CLINICAL TRIAL

Synbiotic for Inflammation

EnrollingByInvitation · 65+ · All Sexes · La Jolla, CA

This study is evaluating whether a synbiotic supplement can improve gut health and mood in older adults.

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About the trial for Inflammation

Eligible Conditions
Inflammation · Microbiome, Human

Treatment Groups

This trial involves 3 different treatments. Synbiotic is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

Experimental Group 1
Synbiotic
DIETARYSUPPLEMENT
Control Group 2
Placebo
DIETARYSUPPLEMENT
Control Group 3
Probiotic
DIETARYSUPPLEMENT

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Synbiotic
2016
Completed Phase 3
~700

Side Effect Profile for Sevelamer

Sevelamer
Show all side effects
14%
Mouth Ulcers
14%
Abdominal Bloating/Flatulence
14%
Nausea
14%
Vasovagal Syncope
0%
Hypertension
0%
Headache
0%
Dehydration
0%
Ear Itching
0%
Diarrhea
0%
Hematoma
0%
Gum Infection
Mouth Ulcers
14%
Abdominal Bloating/Flatulence
14%
Nausea
14%
Vasovagal Syncope
14%
Hypertension
0%
Headache
0%
Dehydration
0%
Ear Itching
0%
Diarrhea
0%
Hematoma
0%
Gum Infection
0%
This histogram enumerates side effects from a completed 2020 Phase 2 trial (NCT02124759) in the Sevelamer ARM group. Side effects include: Mouth Ulcers with 14%, Abdominal Bloating/Flatulence with 14%, Nausea with 14%, Vasovagal Syncope with 14%, Hypertension with 0%.

Eligibility

This trial is for patients born any sex aged 65 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
I need to see a doctor to get medical clearance. show original
able to understand and communicate health information in English; able to understand and follow oral and written instructions in English show original
Cognitively intact;
> 60 years of age.
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 8 weeks
Screening: ~3 weeks
Treatment: Varies
Reporting: 8 weeks
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 8 weeks.
View detailed reporting requirements
Trial Expert
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- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Synbiotic will improve 1 primary outcome and 1 secondary outcome in patients with Inflammation. Measurement will happen over the course of 8 weeks.

Objective measures of gut microbiome health
8 WEEKS
16S rDNA sequencing of stool sample
8 WEEKS
Inflammatory biomarkers
8 WEEKS
Measure concentrations of 30 cytokines in blood samples with standard ELISA panel
8 WEEKS

Who is running the study

Principal Investigator
C. T. P.
Christine T. Peterson, Assistant Project Scientist
University of California, San Diego

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the latest research for inflammation?

Our knowledge was enhanced by this survey. All doctors were aware of the importance of inflammation as a risk factor for atherosclerosis, and they took a proactive preventive approach to patients with chronic diseases.

Anonymous Patient Answer

Can inflammation be cured?

Inflammation appears, on the whole to be a chronic self-defense response against pathogens and exogenous substances that do not pose a threat to the individual. Once an inflammatory response is initiated, however, it evolves through time into a damaging self-defense response that can potentially result in a chronic, almost systemic disorder with high morbidity, and often even mortality.

Anonymous Patient Answer

What are common treatments for inflammation?

There are many ways to reduce inflammation. The most common methods to manage inflammation involve diet, lifestyle, exercise, stress reduction and nutritional supplementation. Anti-inflammatory treatments include corticosteroids, steroids, antibiotics, and NSAIDS. Also, patients may use topical immunomodulators e.g. creams and ointments. These may be prescribed for use for short periods or on a regular basis. However, the evidence base for most treatments is very weak.\n

Anonymous Patient Answer

What are the signs of inflammation?

Cluster headaches should be screened for by migraine or headache attacks when present with nausea and tenderness and/or swelling of the eye or face, but should also be screened for when present with chronic or recurring pain, tenderness to touch, or redness in a specific area of the head, back of neck, eyelids, arm, or leg. The lack of either these signs of inflammation or acute headache or the inability of these signs to respond to analgesics could be used to suspect the presence of intracranial tumor. The diagnosis of orbital cellulitis rests entirely on a history and physical examination.

Anonymous Patient Answer

What is inflammation?

Inflammation is a complex interaction between the nervous and immune systems. The immune system and the central nervous system are tightly intertwined and both may be influenced by inflammation. Chronic inflammation at an earlier stage is implicated in the increased incidence of Alzheimer's disease at a later stage. This article deals with the effects of inflammation in neurological diseases such as Parkinson's disease and Alzheimer's disease. It also highlights the complexities affecting the interaction between the peripheral nervous system and the immune system, particularly in neurological diseases.

Anonymous Patient Answer

What causes inflammation?

T-cells may be involved when in the brain, and they release pro-inflammatory cytokines in the blood when in the gut.\n\nBrain injury to the cortex and white matter is another common cause of psychosis. A number of risk factors including environmental and genetic influences are believed to be involved in psychosis, including environmental factors such as stress or substance abuse, the genetics of the individual, and genetics of the fetus. Psychosis is thought to be associated with the onset of brain injury in the hippocampus, frontal lobe, cerebral cortical regions on both sides of the cerebrum, and the amygdala. Traumatic brain injury is also linked to ADHD and psychosis.\n\nToxins may cause psychosis though acute intoxication.

Anonymous Patient Answer

How many people get inflammation a year in the United States?

Around 1/3 of the American population is subjected to inflammation. For most conditions, women have a higher risk than men. For a minority of diseases, males have a higher risk than females.

Anonymous Patient Answer

Is synbiotic safe for people?

The majority of synbiotics used for the treatment of lactose intolerance in this population were well tolerated and did not pose a risk to normal intestinal function. This trial is registered with www.clinicaltrials.gov (NCT 00604473).

Anonymous Patient Answer

Have there been other clinical trials involving synbiotic?

A clinical trial using synbiotics has not been published. However, clinical trials using synbiotics may use a different dosing of the synbiotic (i.e., a lower dose in clinical and preclinical studies versus clinical studies) or use other modes of administration (e.g., orally, in water, in oil, in tea, or by injection). Results from a recent paperbase and published reviews did not reveal any synbiotics of clinical trials that have been submitted for publication in biomedical journals, and as with other studies on synbiotic therapies, the lack of published studies can possibly be related to the potential safety risks in an unproven and potentially new mode of therapy.

Anonymous Patient Answer

What is synbiotic?

Synbiotics can be defined as, ‘a dietary supplement composed of plant-based foods and microorganism living symbiotically with beneficial effects on human health’. Synbiotics may be beneficial in the digestive system, gastrointestinal barrier, immune system, and CNS, amongst other areas. It is important to be aware of the possibility that synbiotics may be associated with risks in the community.

Anonymous Patient Answer

Who should consider clinical trials for inflammation?

This survey indicates that while clinicians are aware of multiple indications for randomized trials, not all inflammatory diseases are candidates for clinical trials. Physicians and stakeholders need to be more proactive to recruit patients with inflammatory disorders for clinical trials opportunities, especially in the fields of rheumatoid arthritis, systemic lupus erythematosus, and inflammatory bowel disease. Patient advocacy and collaborative health care research between patients and clinicians are critical for the optimal development of clinical trials with patients with inflammatory diseases.

Anonymous Patient Answer

How does synbiotic work?

The use of synbiotic in patients with chronic disease has been largely studied for the treatment or prevention of IBS. This is the first randomized, placebo-controlled trial of synbiotic used as an additional nonpharmacological therapy in patients with CD. In comparison with the control group, the synbiotic group received a significantly greater magnitude of clinical improvement and had better side effects. Synbiotics may be a useful therapeutic agent in patients with CD or other diseases.

Anonymous Patient Answer
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