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

80 Participants Needed

Trial Summary

What is the purpose of this trial?

According to International Scientific Association for Probiotics and Prebiotics (ISAPP), a prebiotic is defined as a substrate that is selectively utilized by host microorganisms conferring a health benefit (Gibson et al, 2017). Fibers/ Prebiotics are known to have several beneficial effects on human health via gut. They remain mostly undigested in upper GI and reach colon where they are fermented by resident gut microbiota. This leads to the production of several beneficial metabolites such as short chain fatty acids and others which are implied in human health. The aim of this study is to examine the effects of combinations of two prebiotics on gut microbiota modulation and Quality of Life at two doses.

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.

What data supports the effectiveness of the treatment in the clinical trial titled 'Prebiotics for Gut Health'?

Research shows that prebiotics can promote the growth of beneficial gut bacteria, which may help with digestive issues like diarrhea and inflammatory bowel diseases. They are also thought to improve immune function and reduce the risk of certain diseases by enhancing gut health. ^{1 2 3 4 5}

Is the prebiotic treatment generally safe for humans?

Prebiotics are generally safe for humans, but they can cause gas, bloating, and sometimes abdominal pain or diarrhea, especially in large doses. People with conditions like irritable bowel syndrome or gastroesophageal reflux may be more sensitive to these effects. ^{6 7 8 9 10}

How is the prebiotic treatment for gut health different from other treatments?

This prebiotic treatment is unique because it promotes the growth of beneficial gut bacteria, like bifidobacteria and lactobacilli, which can improve gut health by enhancing the immune response and reducing harmful bacteria. Unlike other treatments, prebiotics are non-viable food ingredients that are selectively used by these beneficial bacteria, offering a natural way to support gut health with minimal risk of serious side effects. ^{1 5 11 12 13}

Eligibility Criteria

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

Participant must be able to give written informed consent

Exclusion Criteria

I am currently taking medication for anxiety, psychosis, seizures, brain-related issues, pain, or sleep.

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

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Prebiotic 2 Experimental Treatment 1 Intervention

Group II: Prebiotic 1 Experimental Treatment 1 Intervention

Group III: Placebo 2 Placebo Group 1 Intervention

Group IV: Placebo 1 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+

Findings from Research

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

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

2. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Prebiotics--promising alimentary preventors of digestion dysfunctions caused by adverse environmental factors]. [2006]

3. England pubmed.ncbi.nlm.nih.gov

Dietary modulation of the human colonic microbiota: updating the concept of prebiotics. [2008]

4. United States pubmed.ncbi.nlm.nih.gov

Nutritional impact of pre- and probiotics as protective gastrointestinal organisms. [2006]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Microbial-gut interactions in health and disease. Prebiotics. [2005]

6. Germany pubmed.ncbi.nlm.nih.gov

Weight of evidence needed to substantiate a health effect for probiotics and prebiotics: regulatory considerations in Canada, E.U., and U.S. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Tolerance of probiotics and prebiotics. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Prebiotics and the health benefits of fiber: current regulatory status, future research, and goals. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Novel probiotics and prebiotics: road to the market. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Expert consensus document: The International Scientific Association for Probiotics and Prebiotics (ISAPP) consensus statement on the definition and scope of prebiotics. [2022]

11. Italy pubmed.ncbi.nlm.nih.gov

Effects of symbiotic preparations on constipated irritable bowel syndrome symptoms. [2015]

12. Korea (South) pubmed.ncbi.nlm.nih.gov

Prebiotics in the Infant Microbiome: The Past, Present, and Future. [2020]

13. England pubmed.ncbi.nlm.nih.gov

Probiotics and prebiotics in intestinal health and disease: from biology to the clinic. [2022]