Prebiotics for Gut Health

Overseen By Kevin O'Regan, Operations Manager

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Pharmavite LLC

Must not be taking: Anxiolytics, Antipsychotics, Opioids, others

Disqualifiers: Pregnancy, Drug abuse, Immunocompromised, others

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how two different prebiotics can improve gut health and overall quality of life. Prebiotics are special fibers that nourish beneficial bacteria in the gut, leading to health benefits. Participants will receive one of two prebiotic treatments or a placebo to determine which is most effective. Individuals who are generally healthy but consume less than 18 grams of fiber daily might be suitable for this study. As an unphased trial, this study provides a unique opportunity to contribute to scientific understanding and potentially enhance gut health.

Will I have to stop taking my current medications?

The trial requires that you do not change medications or supplements within 90 days before starting and during the study. Certain medications like anxiolytics, antipsychotics, and opioid pain relievers are not allowed. Please check with the study team if your current medications are permitted.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that prebiotics are generally safe for use. Evidence suggests that prebiotics, such as GOSs (a type of sugar that supports gut bacteria), can improve gut health and are usually well-tolerated. Studies have found that they can alleviate issues like constipation by promoting the growth of beneficial gut bacteria.

However, the FDA does not closely regulate prebiotic supplements, resulting in limited detailed safety information. While prebiotics are typically safe, some individuals might experience mild digestive issues like gas or bloating, especially when first using them.

Overall, for those considering participation in a trial involving prebiotics, research indicates they are safe for most people. Consulting a healthcare provider is advisable for any concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for gut health that often rely on probiotics, these investigational prebiotic treatments are designed to nourish the beneficial bacteria already present in your gut. Researchers are excited about Prebiotic 1 and Prebiotic 2 because they work by selectively feeding healthy gut bacteria, potentially enhancing digestion and boosting overall gut health. This approach could lead to a more balanced gut microbiome without directly introducing new bacteria, offering a natural and potentially more sustainable way to improve gut health.

What evidence suggests that this trial's prebiotic treatments could be effective for gut health?

Research has shown that prebiotics benefit gut health. In this trial, participants will receive either Prebiotic 1 or Prebiotic 2. Prebiotic 1 contains galactooligosaccharides (GOSs), which help relieve constipation and improve overall digestion. It also supports mental well-being by promoting the growth of healthy gut bacteria. Prebiotic 2 contains fructooligosaccharides (FOS), which increase the number of beneficial gut bacteria and enhance digestion. Both prebiotics are linked to better gut function and may reduce the risk of certain gut-related issues. These findings suggest that both treatments could effectively improve gut health. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults experiencing dysbiosis, which means their gut bacteria are out of balance. Participants should be interested in improving their quality of life through dietary changes. Specific eligibility criteria were not provided, so generally healthy adults looking to participate in nutritional studies may consider enrolling.

Inclusion Criteria

Participant must consume less than 18g fiber per day

Participant must be able to give written informed consent

Participant's BMI must be between 18.5 - 29.9kg/m2

Exclusion Criteria

Participant with current or recent use of prohibited foods and nutritional or non-nutritional supplements

Participant who, in the opinion of the investigator, is considered to be poor attendees or unlikely for any reason to be able to comply with the study

Participant may not be receiving treatment involving experimental drugs/supplements

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Run-in

Participants undergo a 2-week run-in period before baseline determination

2 weeks

Treatment

Participants receive prebiotic or placebo treatment for 8 weeks

8 weeks

2 visits (1 in-person, 1 virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Treatment

Trial Overview The study tests the effects of two prebiotic combinations on gut health and overall well-being at different doses. One group will receive a placebo with no active ingredients, while the other will get the actual treatment to see if it positively alters gut microbiota and improves life quality.

How Is the Trial Designed?

Group I: Prebiotic 2 Experimental Treatment 1 Intervention

Group II: Prebiotic 1 Experimental Treatment 1 Intervention

Group III: Placebo 1 Placebo Group 1 Intervention

Group IV: Placebo 2 Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Pharmavite LLC

Lead Sponsor

Trials

12

Recruited

27,200+

Atlantia Food Clinical Trials Ltd.

Collaborator

Trials

3

Recruited

210+

Atlantia Food Clinical Trials

Industry Sponsor

Trials

43

Recruited

4,300+

Published Research Related to This Trial

Prebiotics have been shown to potentially reduce the risk and severity of gastrointestinal infections and inflammation, including conditions like diarrhea and inflammatory bowel disease, based on a growing body of evidence.

They may also enhance mineral absorption and help in weight management by promoting feelings of fullness, but further research is needed to clarify how different prebiotics affect human health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prebiotics and the health benefits of fiber: current regulatory status, future research, and goals. Brownawell, AM., Caers, W., Gibson, GR., et al.[2023]

Pre- and probiotics can positively change the gut microbiome, which may enhance the host's health by improving immune function and lipid metabolism, as well as potentially preventing certain diseases like cancer.

The review highlights both supportive and opposing evidence regarding the effectiveness of pre- and probiotics in treating various conditions, including diarrhea, Helicobacter pylori infections, and inflammatory bowel disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional impact of pre- and probiotics as protective gastrointestinal organisms. Teitelbaum, JE., Walker, WA.[2006]

Probiotics and prebiotics have been traditionally consumed for their health benefits, particularly for gut health, and there is growing scientific interest in the gut microbiota's role in health and disease.

While some human diseases, such as diarrheal illnesses and inflammatory bowel diseases, may benefit from probiotics, there is still a lack of extensive clinical evidence supporting their use, especially for prebiotics, which have not been widely tested in large-scale trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prebiotics and probiotics: their role in the management of gastrointestinal disorders in adults. Quigley, EM.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10975713/

Prebiotics and Probiotics for Gastrointestinal Disorders - PMC In summary, the existing evidence suggests that prebiotics, especially GOSs, are safe and effective in improving constipation and may exert ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S266683352500142X

Recent advances in prebiotics: Classification, mechanisms, ... The benefits of prebiotics are extensive, spanning digestive health, metabolic health, immune function, and mental well-being (Selvamani et al., 2023). They ...

3. frontiersin.org frontiersin.org/journals/microbiology/articles/10.3389/fmicb.2024.1487641/full

A comprehensive review of probiotics and human health ... This review focuses on the applications of probiotics, prebiotics and synbiotics in the prevention and treatment of human health.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5622781/

Effects of Probiotics, Prebiotics, and Synbiotics on Human ... Prebiotic substances selectively stimulate microorganisms present in the host's intestinal ecosystem, thus eliminating the need for competition with bacteria.

5. mdpi.com mdpi.com/2227-9032/12/5/510

Probiotics and Prebiotics Affecting Mental and Gut Health This study aimed to reveal the relationship between the intake of probiotic and prebiotic foods and mental and gut health.

6. ods.od.nih.gov ods.od.nih.gov/factsheets/Probiotics-HealthProfessional/

Probiotics - Health Professional Fact Sheet FDA reported that probiotics have been associated with one infant death and more than two dozen other adverse events in recent years, and the ...

7. mayoclinic.org mayoclinic.org/healthy-lifestyle/nutrition-and-healthy-eating/expert-answers/probiotics/faq-20058065

Probiotics and prebiotics: What you should know Prebiotics may trigger the growth of the "good" germs in the gut. Prebiotics mainly are in high-fiber foods. Probiotics and prebiotics also are ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2161831324001637

Revisiting the Concepts of Prebiotic and Prebiotic Effect in ... The purpose of this article is to revisit the concepts of prebiotic and prebiotic effect by providing a scientific-based industry perspective.

9. cghjournal.org cghjournal.org/article/S1542-3565(18)31019-X/fulltext

Prebiotics and Probiotics in Digestive Health For all of these reason probiotics are “generally regarded as safe.” Though reassuring, the literature on probiotic and prebiotic safety lacks ...