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74 Microtia Trials Near You
Power is an online platform that helps thousands of Microtia patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.
Learn More About PowerProbiotics for Cardiovascular Disease in HIV+ Individuals
Nashville, Tennessee
Among people living with HIV, heavy drinking increases the risk of heart disease and death. Studies suggest that alcohol changes the number and kind of bacteria in your gut and these changes increase the risk of heart disease and death. This randomized controlled trial will determine whether a pill containing healthy gut bacteria can increase the number good bacteria in the gut, lower levels of inflammation, and lower the risk of heart disease and death.
Stay on current meds
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Not Fluent In English
250 Participants Needed
Protein Powders for Nutrition
Calgary, Alberta
This study aims to understand how the Milk Protein Concentrate/Fast Protein (MCP/FP) investigational product (IP) compares to a control the Micellar Casein Isolate/Slow Protein (MCI/SP) product in healthy volunteers. It involves two phases where participants will try both products. The main goal is to measure the type and rate of amino acids quickly in the small intestine after consuming the protein products and how this relates to gastric emptying.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:20 - 55
Key Eligibility Criteria
Disqualifiers:Gastrointestinal Disease, Cancer, Pregnancy, Others
Must Not Be Taking:Antidepressants, Antipsychotics, Antihypertensives, Others
20 Participants Needed
RBX2660 for C. Diff Infection
Cleveland, Ohio
This trial will be initiated to explore whether RBX2660 (REBYOTA®) could be suitable for administration by the practice of colonoscopy. More specifically, the purpose of this trial is to explore the safety and clinical effectiveness of RBX2660 when delivered by colonoscopy to adults with rCDI. The experience of physicians will be documented through a physician-experience questionnaire to explore the usability of RBX2660 in clinical practice for colonoscopic administration. Furthermore, to explore the patient-experience of RBX2660 treatment, each trial participant will be offered to undergo a structured interview.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Key Eligibility Criteria
Disqualifiers:Not Listed
41 Participants Needed
Antibiotics for Neonatal Infections
Pittsburgh, Pennsylvania
The goal of the NANO trial is to study the longstanding clinical practice of empirically administering intravenous antibiotics to extremely low birthweight (ELBW) infants in the first days of life. In this 802-subject multicenter placebo-controlled randomized clinical trial, the hypothesis to be tested is that the incidence of adverse outcomes is higher in babies receiving empiric antibiotics (EA) in the first week of life compared to babies receiving placebo. The study targets a population of ELBW infants in whom the clinical decision to use or not use EA is currently most challenging -- infants that are clinically stable that did not have a known exposure to intraamniotic infection and were not born preterm for maternal indications. The primary outcome is the composite outcome of late-onset sepsis (LOS), necrotizing enterocolitis (NEC), or death during the index hospitalization. Secondary safety outcomes will include total antibiotic days, days to full enteral feedings, and common morbidities in preterm infants that have previously been linked to EA, e.g. retinopathy of prematurity and bronchopulmonary dysplasia. Weight and length z-score, and head circumference, are standard measures to be collected weekly by clinical team per a standardized protocol.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:23 - 4
Key Eligibility Criteria
Disqualifiers:Maternal Infection, Respiratory Insufficiency, Hemodynamic Instability, Major Congenital Anomalies, Others
Must Not Be Taking:Antibiotics
802 Participants Needed
Chemotherapy + Stool Transplant for Pancreatic Cancer
London, Ontario
To confirm the safety of combining oral fecal microbiota transplantation (FMT) with gemcitabine and nab-paclitaxel chemotherapy as first line treatment in patients with unresectable or metastatic pancreatic ductal adenocarcinoma.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Key Eligibility Criteria
Disqualifiers:Immunodeficiency, Chronic Intestinal Disease, Others
Must Be Taking:Gemcitabine, Nab-paclitaxel
20 Participants Needed
Salsalate for Endometriosis
University Park, Pennsylvania
The purpose of this study is to better understand the underlying mechanisms associated with elevated cardiovascular disease risk in women with endometriosis, and to measure the effectiveness of emerging endometriosis treatments on outcomes specific to cardiovascular dysfunction.
Epidemiologic data demonstrate a clear association between endometriosis, reproductive risk factors, inflammation and cardiovascular (CV) risk. Circulating factors, low-density lipoprotein (LDL) and oxidized LDL (oxLDL), are two of many biomarkers of cardiovascular and inflammatory disease of endometriosis. An important signaling mechanism through which circulating LDL and oxLDL act is the lectin-like oxidized LDL receptor (LOX-1). LOX-1 signal transduction functionally results in pronounced endothelial dysfunction, a hallmark of CV. The investigators hypothesis that one factor mediating the elevated risk of cardiovascular disease in endometriosis is systemic inflammation and activation of LOX-1 receptor mechanisms.
Trial Details
Trial Status:Recruiting
Trial Phase:Early Phase 1
Age:18 - 45
Sex:Female
Key Eligibility Criteria
Disqualifiers:Diabetes, Hypertension, Pregnancy, Others
Must Be Taking:Oral Contraceptives
24 Participants Needed
MET-2 for Bacterial Blood Infections
Toronto, Ontario
ARO-DECAMP is a multi-centre, placebo-controlled, pilot and feasibility randomized controlled trial for the microbial consortium Microbial Ecosystem Therapeutic-2. Non-intensive care unit patients ≥ 18 years old diagnosed with a bloodstream infection and receiving treatment for an antibiotic resistant organism will be included. Participants will be randomized to receive either MET-2 or placebo for 10 days. Recruitment rate and study intervention adherence will be evaluated for feasibility. Participants will be followed for 180 days, and biological samples will be collected periodically for clinical, ecological, and biomarker outcomes.
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Inflammatory Bowel Disease, Pregnancy, Others
Must Be Taking:Antibiotics
100 Participants Needed
Tagatose for Impaired Glucose Tolerance
Toronto, Ontario
The primary objective of this clinical-trial is to determine, in subjects with impaired fasting glucose (IFG) and/or insulin resistance (IR), if tagatose meets the definition of a prebiotic, namely that consuming tagatose for 4 weeks selectively stimulates the selective growth of bacteria in the colon and is associated with a health benefit (oral glucose tolerance) when compared to consuming the control treatment (10g sucrose) for 4 weeks.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 50
Key Eligibility Criteria
Disqualifiers:Diabetes, IBS, IBD, Pregnancy, Others
Must Not Be Taking:Hypoglycemics, GLP-I Agonists, Steroids, Antipsychotics
55 Participants Needed
Vaginal Seeding for Cesarean-Delivered Infants
Falls Church, Virginia
Neonates delivered by scheduled Cesarean Section will be randomized to receive vaginal seeding (exposing the infant to Mother's vaginal flora) or sham. Infants will be followed for three years to examine health outcomes including microbiome development, immune development, metabolic outcomes, and any adverse events.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Age:0 - 50
Key Eligibility Criteria
Disqualifiers:Diabetes, Genital HSV, Group B Strep, Others
Must Not Be Taking:Antibiotics
600 Participants Needed
Autophagy Activator for Type 2 Diabetes
Milwaukee, Wisconsin
This trial tests whether a sugar called trehalose can help improve small blood vessel function in adults with Type 2 Diabetes. Participants will take trehalose for a short period. Trehalose helps cells clean out damaged parts, which may help blood vessels relax and widen more easily. Trehalose is a naturally occurring disaccharide that has been found to improve glucose metabolism and homeostasis in different diabetes models.
Trial Details
Trial Status:Recruiting
Trial Phase:Early Phase 1
Key Eligibility Criteria
Disqualifiers:Hypertension, Tobacco Use, Heart Failure, Others
Must Not Be Taking:Anticoagulants, Antiplatelets, Steroids, Others
60 Participants Needed
Nasal Bacteria Transfer for Neonatal Infections
Baltimore, Maryland
This study aims to determine whether a parent-to-child nasal microbiota transplant (NMT) can seed and engraft parental organisms into the neonatal microbiome and increase the neonatal microbiome diversity.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:0 - 60
Key Eligibility Criteria
Disqualifiers:S. Aureus Colonization, Immunodeficiency, Respiratory Illness, Others
175 Participants Needed
Nasal Microbiota Transplant for Staphylococcus aureus Colonization
Baltimore, Maryland
This protocol aims to evaluate how NMT affects pediatric nasal microbiome diversity following intranasal mupirocin treatment
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 1
Age:0 - 60
Key Eligibility Criteria
Disqualifiers:Immunodeficiency, Nasal Swab Issues, Others
Must Be Taking:Intranasal Mupirocin
175 Participants Needed
Nasal Microbiota Transplant for Preventing Newborn Infections
Baltimore, Maryland
This trial is testing if transferring healthy bacteria from a parent's nose to their newborn's nose can help protect the baby from harmful bacteria. The study focuses on newborns at Johns Hopkins Hospital. By creating a healthy bacterial environment in the baby's nose, the researchers hope to reduce the risk of infections.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 1
Age:< 60
Key Eligibility Criteria
Disqualifiers:S. Aureus Colonization, Immunodeficiency, Respiratory Illness, Others
34 Participants Needed
MitoTempol for Cognitive Impairment
Newark, Delaware
The goal of this clinical trial is to better understand how day-to-day stress affects cardiovascular health and brain function in middle-aged adults. The main question is aims to answer is whether the link between daily stress and vascular dysfunction is a potential mechanism of increased risk for future cognitive decline. Participants will complete two 15-day "testing cycles" separated by \~6 months. During each cycle, participants will complete two daily assessments of stress and brain health using an online survey tool for 14-consecutive days. On the last day of each cycle, vascular function will be assessed during a laboratory visit.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:40 - 55
Key Eligibility Criteria
Disqualifiers:Cognitive Impairment, Cardiovascular Diseases, Others
Must Not Be Taking:Cardiovascular Drugs, Psychoactive Drugs
20 Participants Needed
Microbiome Influence on Drug Metabolism
Somerville, New Jersey
The investigators will perform single-dose pharmacokinetic (PK) studies in humans following administration of drugs with known microbiome derived metabolism (MDM) in parallel with preclinical studies. By directly comparing laboratory measurements to clinical results, the investigators will be able to confirm the relevance of MDM in vivo, create microbiome-dependent PK profiles of the MDM positive drugs, and establish methodology to capture the contribution of MDM to inter-individual variability in clinical drug PK profiles.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Gastrointestinal, Autoimmune, Viral, Diabetes, Others
Must Not Be Taking:Antibiotics, Immune Modulators
14 Participants Needed
Candesartan for High Blood Pressure in Obesity
Augusta, Georgia
This trial will use chemicals and a drug called Candesartan to study how they affect certain receptors related to blood pressure. It focuses on obese individuals who often have high levels of a substance called ET-1, which is linked to high blood pressure. By blocking these receptors, the study aims to see if it can improve their function and help lower blood pressure in obese people. Candesartan has been studied extensively for its effects on blood pressure, particularly in hypertensive and obese patients.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Early Phase 1
Age:18 - 40
Key Eligibility Criteria
Disqualifiers:Cardiovascular, Pulmonary, Renal, Others
Must Not Be Taking:Nitrates, Anticoagulants
25 Participants Needed
Protein-Enriched Human Milk for Premature Infants
Birmingham, Alabama
This trial is testing whether giving extremely preterm infants milk with extra protein helps them grow stronger and develop healthier guts compared to regular milk. Some infants will receive milk with extra protein shortly after birth, while others will receive regular milk. Researchers hope to see better growth and gut health in the babies who get the extra protein. Protein supplementation of human milk has been studied to improve growth and development in preterm infants, but results have been mixed.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:1 - 4
Key Eligibility Criteria
Disqualifiers:Congenital Malformations, Chromosomal Anomalies, Others
150 Participants Needed
Skin Preparation for Foot and Ankle Surgery
Columbia, Missouri
Surgical site infections (SSIs) make about 31% of all nosocomial infections and they are the most common hospital-acquired infection. For foot and ankle elective interventions, SSI rate is reported between 0.4% and 3.6%. This study will investigate the effectiveness of skin cleaning with isopropyl alcohol and scrubbing with chlorhexidine soap before standard skin preparation in reducing microbial load and surgical site infections for elective foot and ankle surgeries. Current standard of care includes skin preparation with iodine or chlorhexidine solution prior to sterile draping and the start of surgery. Standard of care will be applied to all patients. The use of an additional "pre-scrub" with isopropyl alcohol and scrubbing with chlorhexidine soap will be applied to the experimental group. The control group will receive only the standard of care skin preparation with iodine or chlorhexidine solution prior to draping.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Key Eligibility Criteria
Disqualifiers:Trauma, Open Injuries, Pregnancy, Others
100 Participants Needed
Simvastatin + Duavee for Endometriosis
New Haven, Connecticut
Purpose: To determine the effects of SERM and simvastatin interventions on endothelial dysfunction in women with endometriosis.
Hypothesis: Treatment with the SERM (bazedoxifene + conjugated estrogen) or with simvastatin will decrease systemic inflammation and improve specific measures of cardiovascular function including endothelium-dependent vasodilation.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:18 - 45
Sex:Female
Key Eligibility Criteria
Disqualifiers:Diabetes, Hypertension, Pregnancy, Others
Must Not Be Taking:Cardiovascular Medications
28 Participants Needed
Stevia for Childhood Obesity
Little Rock, Arkansas
This is an 8 to14-week three-arm randomized controlled in children 8 to 12 years old.
The main purpose of the study is to evaluate if stevia (as with other sweeteners and consistent with prior research in children and adults) has benefits for weight control and metabolic function relative to caloric sweeteners, and whether it provides benefits in this regard similar to water.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:8 - 12
Key Eligibility Criteria
Disqualifiers:Obesity, Asthma, Autism, Diabetes, Others
Must Not Be Taking:Antibiotics, Inhalers
210 Participants Needed
Why Other Patients Applied
"I've been struggling with ADHD and anxiety since I was 9 years old. I'm currently 30. I really don't like how numb the medications make me feel. And especially now, that I've lost my grandma and my aunt 8 days apart, my anxiety has been even worse. So I'm trying to find something new."
FF
ADHD PatientAge: 31
"I've tried several different SSRIs over the past 23 years with no luck. Some of these new treatments seem interesting... haven't tried anything like them before. I really hope that one could work."
ZS
Depression PatientAge: 51
"As a healthy volunteer, I like to participate in as many trials as I'm able to. It's a good way to help research and earn money."
IZ
Healthy Volunteer PatientAge: 38
"I was diagnosed with stage 4 pancreatic cancer three months ago, metastatic to my liver, and I have been receiving and responding well to chemotherapy. My blood work revealed that my tumor markers have gone from 2600 in the beginning to 173 as of now, even with the delay in treatment, they are not going up. CT Scans reveal they have been shrinking as well. However, chemo is seriously deteriorating my body. I have 4 more treatments to go in this 12 treatment cycle. I am just interested in learning about my other options, if any are available to me."
ID
Pancreatic Cancer PatientAge: 40
"I changed my diet in 2020 and I’ve lost 95 pounds from my highest weight (283). I am 5’3”, female, and now 188. I still have a 33 BMI. I've been doing research on alternative approaches to continue my progress, which brought me here to consider clinical trials."
WR
Obesity PatientAge: 58
Dietary Intervention for Healthy Habits and Diet
Needham, Massachusetts
The PREDICT 3 study will build on previous research in over 2,000 individuals to further refine machine learning models that predict individual responses to foods, with the aim of advancing precision nutrition science and individualized dietary advice. The study incorporates both standardized and controlled dietary intervention, for the purpose of testing postprandial responses to specific mixed meals, in addition to a free-living period with a dietary record for measuring responses to a large variety of meals consumed in a realistic context, where the role of external factors (e.g. exercise, sleep, time of day) on postprandial responses may be determined. For the first time this PREDICT study is built on top of a commercial product which will allow access to a much larger group of participants who are already collecting large amounts of data through digital and biochemical devices that can contribute to science.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Pregnancy, Recent Heart Attack, Others
250000 Participants Needed
High-Soluble Fiber Diet for Sarcopenia
Boston, Massachusetts
Muscle health declines during aging. One factor that may impact muscle health is the community of bacteria that live in our intestines, but studies aimed at improving muscle health by targeting the gut in older adults are sparse. The primary goal of this study is to use a diet that is enriched in soluble fiber, which is exclusively utilized by gut bacteria to make substances that can impact muscle health, to improve muscle-related measures in older adults.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:65+
Key Eligibility Criteria
Disqualifiers:Malnutrition, Diabetes, Chronic Kidney Disease, Others
Must Not Be Taking:Probiotics, Antibiotics, Immunosuppressants, Corticosteroids
24 Participants Needed
Dairy Products for Heart Health
Boston, Massachusetts
The purpose of the study is to compare the effect of consuming full-fat (regular) and fat-free (skim) milk, as well as full-fat and fat-free yogurt (a fermented dairy product), on microorganisms in your gut as well as the products produced by the gut microbes. We will also determine whether consuming these dairy products affects risk factors for heart disease.The findings of the study will help us determine if heart disease risk factors are modified by the fat content and fermentation of milk. The results may facilitate refinement of public health dietary guidance for cardiovascular disease risk reduction.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:50+
Key Eligibility Criteria
Disqualifiers:Hypertension, Diabetes, Heart Disease, Others
Must Not Be Taking:Antibiotics, Steroids, NSAIDs, Others
20 Participants Needed
Standardized Oral Care for Premature Infant Health
Gainesville, Florida
Premature very low birth weight (VLBW) infants are susceptible to complications related to infrequent and non-standardized oral care. Although the benefits of frequent standardized oral care are known to reduce oral dybiosis (increased level of potentially pathogenic bacteria) and its associated complications in critically ill adults leading to established evidence-based guidelines, no such information exists for VLBW infants. The proposed study will prospectively follow 40 VLBW infants for 4 weeks following birth. Infants will be randomized into 1 of 2 groups. Standardized oral care will be performed every 3-4 hours (Group 1) and every 12 hours (Group 2). Aim 1 will evaluate the feasibility of frequent standardized oral care, Aim 2 will compare the oral microbiome between groups, and Aim 3 will compare respiratory outcomes including the incidence of ventilator associated pneumonia, bronchopulmonary dysplasia and need for respiratory support between infants receiving standardized oral care every 3-4 hours and every 12 hours. Issues related to recruitment, retention, randomization, acceptance by nursing staff, and treatment fidelity will be examined. Saliva samples will be obtained weekly and analyzed using 16S sequencing, respiratory cultures will be obtained weekly on ventilated infants, and respiratory outcomes will be collected from the medical records.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:12 - 72
Key Eligibility Criteria
Disqualifiers:Congenital Anomalies, Not Expected To Survive
150 Participants Needed
Meal Effects on Nutrient Tracking
College Station, Texas
The goal of this clinical trial is to establish the relationship between macronutrient food intake and the resulting blood and intersticial fluid (ISF )levels of small molecule markers, as well as, validate wearable optical readers and data fusion algorithms to accurately predict individual-specific macronutrient availability in real time.
The study involves 1 screening visit of approximately 2 hours and up to 4 study days of approximately 14 hours. Subjects will be asked to arrive in the fasted state on all study days. Fasting prior to screening is not required. On the screening visit, body weight, height, and body composition by Dual-energy X-ray absorptiometry (DXA) will be measured. In addition, habitual dietary intake, physical activity level (PASE), and quality of life (SGRQ-C) will be assessed.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:50 - 75
Key Eligibility Criteria
Disqualifiers:Malignancy, Diabetes, Metabolic Diseases, Others
Must Not Be Taking:Anticoagulants
33 Participants Needed
Haskap for Digestion
Bozeman, Montana
Diet is a key factor in managing health and individuals at risk of developing metabolic syndrome or other chronic diseases have the opportunity to use diet as a tool to improve their health. This can be complicated when considering the numerous variables that impact digestion and absorption of key health-promoting compounds in foods. One of these variables is the gut microbiome, a microbial community in the digestive tract that interacts with the foods we consume. The mechanisms the microbiome uses to interact with bioactive compounds in foods, like polyphenols, can modulate the health-promoting benefits of polyphenols. Polyphenols are secondary plant metabolites, commonly found in fruit, legumes, chocolate, coffee, and nuts among other foods that have been shown to improve cardiovascular and metabolic health, as well as reduce inflammation and oxidative stress.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 45
Key Eligibility Criteria
Disqualifiers:Allergy, Antibiotics, Supplements, Smoking, Diabetes, Others
Must Not Be Taking:Cholesterol, Inflammation, Lipids
8 Participants Needed
Haskap Berries for Gut Health
Bozeman, Montana
Polyphenol-rich Haskap berries (Haskap) have untapped therapeutic potential to improve human health, and agricultural producers in northern U.S. states are poised to increase production if consumer demand increases. A critical knowledge gap is that little is known about the interactions between gut microbes and Haskap polyphenols to produce bioactive metabolites linked to downstream health impacts. Additionally, little is known about which Haskap varieties and harvest timing yield the greatest bioactive potential. This study aims to address these gaps by investigating the interaction of bioactive components in Haskap with gut microbiota and the resultant gut and serum metabolites, inflammation, and metabolic health, and then couple this with analysis of berries from different Haskap varieties and harvest times.
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:35 - 65
Key Eligibility Criteria
Disqualifiers:Diabetes, BMI <18 Or >40, Others
Must Not Be Taking:Anti-inflammatory, Lipid Lowering, Glucose Lowering, Blood Pressure
120 Participants Needed
Fecal Microbiota Transplantation for Kidney Stones
Park City, Utah
The purpose of this study is to measure the impact of Microbial Transplant Therapy (MTT) on 24-hour urine parameters in recurrent hypercalciuric and hyperoxaluric kidney stone formers.
Trial Details
Trial Status:Recruiting
Trial Phase:Early Phase 1
Key Eligibility Criteria
Disqualifiers:Metabolic Syndrome, Autoimmunity, IBD, Others
Must Not Be Taking:Potassium Citrate, Thiazides, PPIs
36 Participants Needed
Donor Milk for Infant Microbiome
Calgary, Alberta
The objective of this novel study is to establish proof of concept using a pilot randomized controlled trial to determine the effect of DHM compared to formula supplementation on the microbiome in full-term infants who are born via caesarean section and require supplementation. Secondarily, this study aims to compare the infant health outcomes of sleep and growth between groups to assess if these outcomes are mediated by infant feeding type or potential differences in microbial signatures. Finally, this study will compare maternal outcomes of depression, anger, breastfeeding self-efficacy and breastfeeding rates between groups.
The infant gut microbiome plays a critical role in the developing immune, neurologic, and endocrine systems. Yet, most infants experience early life disruptions (ELDs) to their microbiome that have potential long-term health and development impacts. A major source of disruption is caesarean section (c-section) delivery because the infant is born surgically and is not exposed to important commensal bacteria required to establish the infant microbiome. Currently in Canada, over 28% of infants are born via c-section.
Exclusive breastfeeding can improve gut microbiota composition in infants who are born via c-section. However, approximately 60% of infants born via c-section require formula supplementation in their first week of life. Evidence indicates that even one bottle of formula can further disrupt the gut microbiome.
Donor human milk (DHM) is a superior alternative to formula when supplementation is required as its biotic properties minimize perturbations to the infant gut microbiome and may help to repair the microbiome in infants who experience ELDs. Yet, while DHM is well researched in preterm populations, evidence on the impact of DHM as a therapeutic intervention on the full-term infant gut microbiome is lacking.
The hypothesis of this study is: that replacing formula with DHM supplementation will minimize gut microbiome dysbiosis and foster homeostasis following supplementation. In addition, it is hypothesized that improved homeostasis will promote improved sleep and growth outcomes in participant infants. Finally, mothers whose infants receive DHM will have lower depression and anger scores and higher breastfeeding self-efficacy and exclusive breastfeeding rates compared to mothers whose infants receive formula.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:37+
Key Eligibility Criteria
Disqualifiers:Congenital Malformation, No Breastfeeding Intention
90 Participants Needed
Donor Human Milk for Infant Gut Health
Calgary, Alberta
This trial is testing whether giving donor human milk instead of formula to full-term infants can help maintain healthy gut bacteria. The study aims to see if this can improve the babies' sleep, growth, and overall health. The trial also looks at how this affects the mothers' mental health and breastfeeding success.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:37+
Key Eligibility Criteria
Disqualifiers:Major Congenital Malformation, Others
Must Not Be Taking:Extended Antibiotics
105 Participants Needed
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We started Power when my dad was diagnosed with multiple myeloma, and I struggled to help him access the latest immunotherapy. Hopefully Power makes it simpler for you to explore promising new treatments, during what is probably a difficult time.
Bask GillCEO at Power
Frequently Asked Questions
How much do Microtia clinical trials pay?
Each trial will compensate patients a different amount, but $50-100 for each visit is a fairly common range for Phase 2–4 trials (Phase 1 trials often pay substantially more). Further, most trials will cover the costs of a travel to-and-from the clinic.
How do Microtia clinical trials work?
After a researcher reviews your profile, they may choose to invite you in to a screening appointment, where they'll determine if you meet 100% of the eligibility requirements. If you do, you'll be sorted into one of the treatment groups, and receive your study drug. For some trials, there is a chance you'll receive a placebo. Across Microtia trials 30% of clinical trials have a placebo. Typically, you'll be required to check-in with the clinic every month or so. The average trial length for Microtia is 12 months.
How do I participate in a study as a "healthy volunteer"?
Not all studies recruit healthy volunteers: usually, Phase 1 studies do. Participating as a healthy volunteer means you will go to a research facility several times over a few days or weeks to receive a dose of either the test treatment or a "placebo," which is a harmless substance that helps researchers compare results. You will have routine tests during these visits, and you'll be compensated for your time and travel, with the number of appointments and details varying by study.
What does the "phase" of a clinical trial mean?
The phase of a trial reveals what stage the drug is in to get approval for a specific condition. Phase 1 trials are the trials to collect safety data in humans. Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more promising than phase 1.
Do I need to be insured to participate in a Microtia medical study?
Clinical trials are almost always free to participants, and so do not require insurance. The only exception here are trials focused on cancer, because only a small part of the typical treatment plan is actually experimental. For these cancer trials, participants typically need insurance to cover all the non-experimental components.
What are the newest Microtia clinical trials?
Most recently, we added Nasal Microbiota Transplant for Staphylococcus aureus Colonization, MET-2 for Bacterial Blood Infections and Haskap for Digestion to the Power online platform.
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