Fiber Supplement for Digestive Issues

Overseen By Robert Ganz, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Bell Cinical Service

Disqualifiers: Thyroid disease, Pelvic floor disorder, Inflammatory bowel disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new fiber supplement that combines eight different types of fiber. The goal is to determine if it reduces bloating and gas while improving bowel movements by promoting a healthier gut environment. The trial seeks individuals with ongoing digestive issues such as straining, hard stools, or abdominal pain that disrupts daily life. Participants should have experienced these symptoms for at least three months, affecting their quality of life. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance digestive health.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this fiber supplement is safe?

Research has shown that fiber supplements are generally safe for most people. For example, one study found that including fiber in diets reduced the risk of digestive problems by 39% compared to diets without fiber. This suggests that fiber can help maintain gut health. Additionally, fiber supplements usually have few side effects, and most people don't report major issues. However, it's important to remember that everyone is different. A type of fiber that works well for one person might not be as effective or could cause discomfort for someone else. Always consider individual experiences and consult a healthcare provider if unsure. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike typical treatments for digestive issues, which often include medications or lifestyle changes, this new fiber supplement offers a natural approach by directly enhancing dietary fiber intake. Researchers are excited because it leverages a simple yet effective mechanism—boosting fiber levels to improve digestion and gut health. This supplement could provide a gentler, more sustainable alternative to medications, potentially reducing side effects while promoting overall digestive wellness.

What evidence suggests that this fiber product might be an effective treatment for digestive issues?

Studies have shown that fiber supplements can improve digestive health by making bowel movements more regular and maintaining gut health, which can reduce bloating and gas. Some research also suggests that fiber can help lower cholesterol and improve blood sugar levels. A diverse gut bacteria population generally reduces the likelihood of inflammation, leading to more comfortable digestion. Participants in this trial will receive a fiber supplement to evaluate its effects on digestive issues. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals experiencing abdominal bloating, flatulence, and constipation. Participants should be interested in trying a new fiber supplement to improve their gut health. Specific eligibility criteria are not provided, but typically participants would need to meet certain health conditions.

Inclusion Criteria

My symptoms are long-lasting, affect my daily life, and lower my quality of life.

My bowel movements are mostly of a specific type.

I have had stomach pain or discomfort for at least 3 months, starting over 6 months ago.

Exclusion Criteria

Known allergies or intolerance to fiber products

I have a type of inflammatory bowel disease.

I experience loss of bowel control or have a rectal prolapse.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the fiber supplement to evaluate its effects on bloating, gas, and bowel movements

6 weeks

Baseline and 6-week assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Fiber Product

Trial Overview The study tests an over-the-counter fiber supplement that combines 8 different fibers aimed at diversifying the microbiome and reducing inflammation in the gut. The goal is to see if this product can alleviate symptoms of bloating, gas, and irregular bowel movements.

How Is the Trial Designed?

Group I: Fiber supplemenmt Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Bell Cinical Service

Lead Sponsor

Trials

1

Recruited

100+

LX Medical

Collaborator

Trials

1

Recruited

100+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11671356/

Dietary fiber influence on overall health, with an emphasis on ... These fibers are essential for maintaining digestive health, as they aid in promoting regular bowel movements and fostering a balanced gut ...

2. med.stanford.edu med.stanford.edu/news/all-news/2022/04/fiber-supplements.html

Fiber supplements aren't one-size-fits-all, study shows The study showed that high fiber consumption led to a rise in gut-bacteria-derived bile acids, which break down cholesterol and other lipids, ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S221226721631187X

Understanding the Physics of Functional Fibers in ... This review will focus on the beneficial effects of the isolated functional fibers found in fiber supplements, which are readily assessed for efficacy and ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5413815/

Fiber supplements and clinically proven health benefits The physical effects of fiber in the small intestine drive metabolic health effects (e.g., cholesterol lowering, improved glycemic control), and ...

5. journals.lww.com journals.lww.com/nutritiontodayonline/fulltext/2015/03000/evidence_based_approach_to_fiber_supplements_and.9.aspx

Evidence-Based Approach to Fiber Supplements and ... A high level of dietary fiber consumption (eg, replacement) has been associated with a 30% reduction in the risk of gaining weight or developing obesity.42–44 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6676347/

An Overview of Fiber and Fiber Supplements for Irritable ... JM Generally, fiber supplementation in IBS is considered safe, with few adverse events reported. However, supplementation with fiber is contraindicated in ...

7. aspenjournals.onlinelibrary.wiley.com aspenjournals.onlinelibrary.wiley.com/doi/10.1002/jpen.2210

Safety of Using Enteral Nutrition Formulations Containing ... Models showed 39% lower risk of gastrointestinal (GI) complications overall for fiber compared with nonfiber groups (pooled RR: 0.61; 95% CI ...

8. journals.lww.com journals.lww.com/nutritiontodayonline/fulltext/2015/03000/evidence_based_approach_to_fiber_supplements_and.8.aspx

Evidence-Based Approach to Fiber Supplements and ... This 2-part series will focus on the 4 main characteristics of fiber supplements that drive clinical efficacy (solubility, degree/rate of fermentation, ...