Microbiome

New York, NY

22 Microbiome Trials near New York, NY

Power is an online platform that helps thousands of Microbiome 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.

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No Placebo
Highly Paid
Stay on Current Meds
Pivotal Trials (Near Approval)
Breakthrough Medication

L-Phenylalanine for Gut Health

New York, New York
The purpose of this study is to explore how the dietary supplement L-Phenylalanine affects the production of the metabolite phenylpropionic acid (PPA) and changes fungal populations of the gut microbiome.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 4

20 Participants Needed

Antibiotics for Protecting Gut Bacteria During Stem Cell Transplant

New York, New York
The purpose of this study is to see how different antibiotics affect the community of friendly bacteria existing in the intestinal tract (gut). Under normal circumstances, these friendly bacteria are not harmful and they help with normal bodily functions such as digestion. When these bacteria are absent, several complications may occur, such as infections with harmful bacteria or other inflammatory reactions, that can complicate the stem cell transplant course. Treatment with antibiotics or chemotherapy is known to kill off these friendly bacteria. In this study we compare the effects of different antibiotics on the community of friendly bacteria in the gut. For microbiota-related biomarker analysis, optional urine samples (MSKCC patients only) will be collected at baseline, 7 +/-2 days after initiation of antibiotic therapy, and on post-transplant days +28, +56 and +100 (+/- 7days).
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Phase 2

347 Participants Needed

Whole Food Plant-Based Smoothie for Knee Replacement

New York City, New York
This study aims to assess the feasibility of a 2-week dietary whole-food smoothie intervention and compare outcomes between two groups: patients that integrated a daily whole food plant-based smoothie into their diet for two weeks prior to surgery, and a control group of revision TKA patients that made no nutritional changes to their diet prior to surgery. The main research questions are: 1. Among patients planned for elective TKA revision surgery, what is the feasibility of a 2-week dietary intervention implemented 2 weeks prior to surgery? \[Outcomes will be compliance, noted barriers and/or facilitators, satisfaction with diet\] 2. Determine if the implementation of a daily whole food plant- based smoothie dietary supplement 2 weeks prior to TKA revision surgery will reduce inflammation -measured in plasma levels of IL-6 and CRP- at POD0, POD1, POD2, POD3, and 6 Weeks Post-operative as compared to 1) baseline (prior to dietary intervention initiation) and 2) control patients who did not make changes in their diet prior to surgery. 3. Determine if the implementation of a daily whole food plant-based smoothie dietary supplement 2 weeks prior to TKA revision surgery will result in quantifiable changes in the gut microbiome composition -measured via fecal samples- as compared to control patients who did not make changes in their diet prior to surgery. 4. Determine if the implementation of a daily whole food plant- based smoothie dietary supplement 2 weeks prior to TKA revision surgery will result in improved immediate postoperative pain -measured through numeric rating scale (NRS) pain scores- and opioid use -measured in morphine milligram equivalents (MME)- as compared to control patients. 5. Compare patient satisfaction and adoption of nutritional behavioral changes in patients implementing a whole food plant-based smoothie 2 weeks prior to TKA revision surgery to patients undergoing the same surgery but did not me pre-surgery dietary changes. The researcher's primary outcome is measuring feasibility and patient compliance with smoothie consumption. Secondarily, the investigators are interested in measuring if the preoperative smoothie can alter the gut microbiome and decrease systemic inflammation, leading to lowered post-operative pain and opioid use.
No Placebo Group

Trial Details

Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:40 - 80

24 Participants Needed

High Fructose Diet for Obesity

New York, New York
Americans commonly consume excess amounts of dietary fructose. Added fructose has been shown to have an adverse impact on metabolic health, including increased insulin resistance and type 2 diabetes (T2D) risk. However, the mechanisms that link dietary fructose and metabolic health are poorly understood. Malabsorption or incomplete metabolism of fructose in the small intestine is common in the population. Excess fructose reaches the colon where it may change the structure and function of the gut microbiome, alter bacterial metabolites and trigger inflammatory responses impacting T2D risk. To elucidate whether commonly consumed levels of dietary fructose influence metabolic outcomes through altering the gut microbiome, the research team will randomize 30 participants to a controlled cross-over dietary intervention, in which the participants will consume 12-day isocaloric, added fructose or glucose diets (25% of total calories) separated by a 10-day controlled diet washout period. The research team aims to: 1. Determine the relationships between high fructose consumption, the gut microbiome and metabolic risk. 2. Characterize the causal role(s) that fructose-induced alterations to the gut microbiome have on metabolic risk using a germ-free mouse model. The research team will measure 1) microbiota community structure and function via metagenomic sequencing of stool, 2) fecal metabolites via targeted and untargeted metabolomics, 3) anthropometrics, 4) insulin resistance, serum markers of T2D risk and inflammatory cytokines, 5) fecal microbial carbohydrate oxidation capacity and 6) liver fat via MRI elastography. The research team will use novel statistical approaches, including Distributed Lag Modeling, to understand the complex relationships between diet, the microbiome, metabolites and health outcomes. The research team will then conduct controlled dietary interventions and fecal microbiome transplantation studies in germ-free mice. Donor fecal samples from human participants in both the glucose and fructose arms of the clinical intervention will be transplanted into germ-free and colonized mice to establish a causal relationship between fructose-induced changes to the gut microbiome, liver fat and metabolic and inflammatory changes known to increase risk for T2D. The research team aims to comprehensively assess the structural and functional changes to the gut microbiome brought about by a high fructose diet. Determining the impact of excess fructose on the microbiome will help identify novel means by which fructose contributes to metabolic disease risk. In addition to identifying strategies to improve metabolic health in adults, data from this proposal could help inform targeted approaches to mitigate future disease risk in vulnerable populations that consume high levels of fructose, such as children.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:25 - 45

11 Participants Needed

Gut Microbiome Pill for Healthy Subjects

New York, New York
The purpose of this study is to evaluate the safety and efficacy of a 3D-printed ingestible pill designed to sample microbiota from the GI tract, focusing on the ability to collect data also from the small intestine. The study also aims to assess ease of use and transit time.
No Placebo Group

Trial Details

Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:18 - 65

10 Participants Needed

Walnuts for Colon Health

New York, New York
This trial studies if eating walnuts daily can improve gut bacteria, reduce inflammation, and benefit colon tissue in people having a colonoscopy. Walnuts have been shown in animal studies to inhibit colorectal cancer growth and alter gut microbiota.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:39 - 75

200 Participants Needed

Digital Health Coaching for Cancer Survivorship

New York, New York
This study intends to explore feasibility, acceptability, and outcomes related to the use of a digital health coaching intervention for individuals who have completed primary therapy for cancer. Up to 625 individuals with diverse cancer diagnoses will be enrolled across up to 8 clinical sites to participate in a randomized wait-list control study. Those in the intervention group will receive 6 months of digital coaching up front followed by 6 months of ongoing monitoring via patient reported and clinical outcomes, as well as wearable data. Those in the control group will be monitored via patient reported and clinical outcomes as well as wearable data for the first 6 months followed by 6 months of digital health coaching. Both groups will collect fecal microbiome samples at enrollment and month 6. The study aims to explore if and how digital health coaching may be used to enhance outcomes for individuals following completion of primary cancer therapy.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased

625 Participants Needed

ShA9 Topical Gel for Eczema

New York, New York
This is a Phase 1b, randomized, placebo/vehicle-controlled, double-blinded, multi-center trial. It is designed to assess the safety and efficacy of S. hominis A9 (ShA9) topical application as a treatment for atopic dermatitis (AD). The trial will enroll adults and adolescents with atopic dermatitis who are culture positive for S. aureus colonization. The primary safety objective of this study is to compare the safety profile of ShA9 to placebo (vehicle) over 14 weeks of application, which includes an initial two-week period of co-treatment with topical corticosteroids (TCS). The primary efficacy objective of this study is to assess the ability of ShA9, compared to placebo (vehicle), to prolong the period of atopic dermatitis control over 12 weeks after conclusion of an initial two-week period of co-treatment with TCS.

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 1, 2
Age:12+

86 Participants Needed

Butyrate for Rheumatoid Arthritis

New York, New York
This trial tests a supplement with small molecules for RA patients who don't improve with standard treatment. The supplement aims to change gut bacteria and improve immune responses. These molecules are involved in the body's inflammatory response and immunity.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased

35 Participants Needed

Nutritional Optimization for Heart Failure

New York, New York
The goal of this clinical trial is to assess whether a peri-operative intervention with nutritional immune modulating intervention (Ensure Surgery Immunonutrition shake) has beneficial effects on the complex interplay between gut microbiome, systemic inflammation and malnutrition that is commonly present in advanced heart failure and the adverse events associated with left ventricular assist device (LVAD) placement in hospitalized advanced heart failure patients awaiting LVAD implantation. The main questions it aims to answer are: * Will pre-surgical supplementation with Ensure Surgery affect gut microbial composition and levels of inflammation among heart failure patients undergoing LVAD implantation? * Will pre-surgical supplementation with Ensure Surgery affect post-surgical morbidity (e.g., infections, intensive care unit length of stay (LOS)) and mortality? Participants will be evaluated for malnutrition and will be given Ensure Surgery Immunonutrition shake to drink in the days preceding their LVAD surgery. Blood and stool samples will be collected at prespecified timepoints before and after surgery. Researchers will compare malnourished participants drinking Ensure Surgery 3/day with well-nourished participants randomized to drink either 1/day or 3/day to see if any of the above supplementation strategies change the gut microbial composition, levels of inflammation, and post-surgical morbidity and mortality.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased

50 Participants Needed

Antibiotics for Neonatal Infections

New York, New York
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:Active Not Recruiting
Trial Phase:Phase 4
Age:23 - 4

802 Participants Needed

Pembrolizumab + Chemotherapy for Pancreatic Cancer

New York, New York
A multi-institutional, single arm pilot study of antibiotics and pembrolizumab, following chemotherapy for the treatment of surgically resectable pancreatic cancer.
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 2
Age:19+

25 Participants Needed

Vancomycin for Multiple Sclerosis

New York, New York
This trial is testing vancomycin, an antibiotic, to see if it can change gut bacteria and help reduce brain inflammation in people with multiple sclerosis (MS). The goal is to understand if altering gut bacteria can improve immune function and lessen MS symptoms.

Trial Details

Trial Status:Recruiting
Trial Phase:Phase 1
Age:18 - 50

12 Participants Needed

Nutritional Supplement for Healthy Nutrition

Hempstead, New York
This study is a randomized, double-blind, placebo-controlled study of N=20 active men and women. This study to assess the effect of a novel dietary supplement on improving nutrient gaps and the gut microbiome.

Trial Details

Trial Status:Recruiting
Age:18 - 40

20 Participants Needed

Azithromycin Impact on Exercise Performance

New Brunswick, New Jersey
The gut microbiome refers to the trillions of bacteria that inhabit the stomach and other regions involved in the digestion of food, including the intestines. Compelling studies of animals (rodents) suggest that the health of the gut microbiome may influence skeletal muscle function and exercise performance. To date, there have been no similar observations reported in humans. A common experimental approach in animal studies to temporarily disrupt the gut microbiome is through the use of antibiotic therapies. Azithromycin is an antibiotic medicine prescribed to humans for the treatment of mild to moderate infections caused by bacteria. The purpose of the proposed project is to determine the influence of short-term (5-days) antibiotic therapy (azithromycin) on exercise performance in young, healthy adults. Treadmill exercise performance will be compared in two groups of adults before and after 5-days ingestion of azithromycin, or a placebo (something that has no physical effect).
No Placebo Group

Trial Details

Trial Status:Recruiting
Trial Phase:Early Phase 1
Age:18 - 40

40 Participants Needed

Grape Powder for Psychological Distress

New Brunswick, New Jersey
The goal of this trial is to investigate the effect of freeze-dried table grape powder (FTGP) on psychological distress and gut microbiota in college students. The main questions it aims to answer are: Does FTGP reduce anxiety, depression, and perceived stress? Does FTGP improve the gut microbiota? Researchers will compare FTGP to a placebo to see how FTGP affects psychological distress and gut microbiota. Participants will: Drink a daily supplement containing FTGP or a placebo for 4 weeks. Record consumption of grape powder or placebo in a compliance log. Complete surveys and provide stool samples. Three in-person visits.

Trial Details

Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 30

50 Participants Needed

Postcoital Sponge for Vaginal Health

Mountain Lakes, New Jersey
LiviWell has developed a product designed for postcoital semen absorption. Previous studies have demonstrated the product rapidly absorbs semen, and leads to less symptoms of postcoital vaginal microbiome disruption such as vaginal odor and discharge. This study will investigate the study device, Livi, in a broader clinical setting.
No Placebo Group

Trial Details

Trial Status:Not Yet Recruiting
Sex:Female

1000 Participants Needed

Time-Restricted Eating + Calorie Restriction for Weight Loss and Bone Health

New Brunswick, New Jersey
This trial is testing a diet where older women who are overweight or obese eat only during certain times and reduce their calorie intake. The goal is to see if this helps them lose weight, improve heart health, and strengthen bones by changing gut bacteria.
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:50 - 79
Sex:Female

48 Participants Needed

Stool Transplant for Immunotherapy-Related Diarrhea

New York, New York
This trial is testing a treatment called fecal microbiota transplantation (FMT) to help patients with diarrhea caused by cancer treatments. FMT involves transferring stool from a healthy person into the intestines of a sick person. The healthy bacteria in the donor's stool are expected to replace the unhealthy bacteria in the recipient's gut, improving their symptoms. FMT has been proven to be a safe and effective treatment for Clostridium difficile infection (CDI) and it is now a recommended treatment for recurrent or refractory infection.
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Phase 1

4 Participants Needed

GSK3882347 for Urinary Tract Infection (UTI)

Bronx, New York
This trial tests a new medication, GSK3882347, to treat urinary tract infections in adult women. The study will see if the medication can effectively clear the infection and check for any side effects. Participants will take the medication for a short period, and researchers will compare it to an existing treatment to ensure accurate results.

Trial Details

Trial Status:Recruiting
Sex:Female

122 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 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

"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

"I have dealt with voice and vocal fold issues related to paralysis for over 12 years. This problem has negatively impacted virtually every facet of my life. I am an otherwise healthy 48 year old married father of 3 living. My youngest daughter is 12 and has never heard my real voice. I am now having breathing issues related to the paralysis as well as trouble swallowing some liquids. In my research I have seen some recent trials focused on helping people like me."

AG
Paralysis PatientAge: 50

"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

Diet-CD for Crohn's Disease During Pregnancy

New York, New York
This trial tests if a special diet during pregnancy can improve gut health in women with Crohn's disease and their babies. The goal is to create a healthier balance of gut bacteria, which may help reduce disease relapse in mothers and lower gut inflammation in babies. The study will collect various samples to analyze the effects of the diet.
No Placebo Group

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Unphased
Sex:Female

194 Participants Needed

IV Bacteriophage Therapy for Cystic Fibrosis

New Hyde Park, New York
This is a phase 1b/2 study of a single dose of intravenous (IV) bacteriophage in males and non-pregnant females, at least 18 years old, diagnosed with Cystic Fibrosis (CF). This clinical trial is designed to assess the safety and microbiological activity of bacteriophage product Walter Reed Army Institute of Research- PAM-Cystic Fibrosis1 (WRAIR-PAM-CF1), directed at Pseudomonas aeruginosa in clinically stable CF individuals chronically colonized with P. aeruginosa. WRAIR-PAM-CF1 is a 4 component anti-pseudomonal bacteriophage mixture containing between 4 x 10\^7 and 4 x 10\^9 Plaque Forming Units (PFU) of bacteriophage. Enrollment will occur at up to 20 clinical sites in the United States. In stage 1, two eligible subjects will be assigned to each of the three dosing arms receiving a single dosage of the IV bacteriophage therapy (4 x 10\^7 PFU, 4 x 10\^8 PFU, and 4 x 10\^9 PFU; total of 6 sentinel subjects), followed by 30 plus or minus 7 days observation period. If no Serious Adverse Events (SAEs)(related to the study product) are identified during the 96 hours after bacteriophage administration for all Sentinel Subjects in Stage 1, the study will proceed to Stage 2. In Stage 2a, 32 subjects will be enrolled into one of 4 arms (placebo IV, 4 x 10\^7 PFU, 4 x 10\^8 PFU, and 4 x 10\^9 PFU) in a 1:1:1:1 allocation. An interim analysis will be performed after all subjects have completed follow up visit 5 on Day 8+3 to select the IV bacteriophage dose with the most favorable safety and microbiological activity profile. During Stage 2b, subjects will be randomized into the bacteriophage (dose selected based on Interim Analysis following Stage 2a) or placebo arm. The final sample size is expected to be up to 72 subjects total with up to 25 subjects in the placebo arm and up to 25 subjects in the Stage 2b bacteriophage dose.

Trial Details

Trial Status:Active Not Recruiting
Trial Phase:Phase 1, 2

73 Participants Needed

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