FiberSmart for Gut Microbiome Health

IW
Overseen ByIsaac Wong
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a prebiotic supplement called FiberSmart affects the bacterial community in the small intestine of healthy individuals. Researchers aim to understand the impact of prebiotics on the upper digestive system, as most studies have focused on the large intestine. Participants will take either FiberSmart or a placebo (an inactive look-alike substance) for 21 days. This study suits individuals without known gut issues who can easily swallow a capsule. As a Phase 4 trial, FiberSmart has already received FDA approval and proven effective. This research seeks to understand its benefits for more patients, offering participants a chance to contribute to broader health insights.

Will I have to stop taking my current medications?

You may need to stop taking certain medications before joining the study. If you're using prescription medications, you must stop 14 days before the study starts, unless it's oral contraceptives. If you're using Proton Pump Inhibitors (PPIs), you need to stop them 24 hours before and 4 hours after taking the SIMBA capsule.

What is the safety track record for FiberSmart?

Research has shown that FiberSmart is generally safe for people. One study found that increasing the amount of FiberSmart did not lead to more stomach or digestive issues, indicating participants tolerated it well. Another study confirmed that prebiotic fibers, such as FiberSmart, are safe and can aid digestion. Health experts state there is no specific limit on safe dietary fiber intake, suggesting that FiberSmart is unlikely to cause harm when used as directed.12345

Why are researchers enthusiastic about this study treatment?

Unlike traditional treatments for gut health that often focus on probiotics or medications, FiberSmart is unique because it acts as a prebiotic. This means it specifically nourishes and boosts the beneficial bacteria already present in the gut, promoting a healthier microbiome. Researchers are excited about FiberSmart because it offers a more natural approach, potentially enhancing gut health without the side effects that sometimes accompany other treatments. Plus, by directly feeding the good bacteria, FiberSmart might improve digestive health more effectively and sustainably.

What evidence suggests that FiberSmart might be an effective treatment for gut microbiome health?

Studies have shown that prebiotic supplements like FiberSmart can increase beneficial bacteria in the gut, such as Bifidobacterium. This boost strengthens the gut lining and supports the immune system, improving gut health. Research also indicates that fiber supplements can decrease harmful bacteria, aid digestion, and enhance overall gut function. Short-term, consistent fiber use leads to positive changes in gut bacteria, supporting better bowel health. In this trial, participants will receive either FiberSmart or a placebo to evaluate its effectiveness in promoting a healthier gut environment.46789

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 19-40 who do not have any gastrointestinal diseases or recent GI surgeries, are not pregnant or breastfeeding, can swallow a capsule, and haven't used antibiotics, certain medications, probiotics, prebiotics, or fiber supplements recently.

Inclusion Criteria

I am male or a female who is not pregnant, not breastfeeding, and at least 6 weeks postpartum.
At least a four-week washout period between the completion of a previous research study that required ingestion of any study food or drug and their start in the current study
I am between 19 and 40 years old.
See 3 more

Exclusion Criteria

I have fewer than three bowel movements each week.
I cannot stop taking my acid reflux medicine before and after the SIMBA capsule.
I have not had major digestive tract surgery or radiation that could block my intestines.
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants ingest either the FiberSmart or a matched Placebo daily for 21 days

3 weeks
Daily ingestion, with monitoring at baseline and endpoint

Follow-up

Participants are monitored for safety and effectiveness after treatment

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • FiberSmart

Trial Overview

The study tests the effects of a prebiotic supplement called FiberSmart versus a placebo on gut bacteria in the small intestine. Participants take either FiberSmart or placebo daily for 21 days. The study uses special capsules to collect samples from the small intestine.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: PrebioticExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Nimble Science Ltd.

Lead Sponsor

Trials
11
Recruited
570+

Anderson Advanced Ingredients

Industry Sponsor

Trials
2
Recruited
30+

Citations

Prebiotics and Gut Health: Mechanisms, Clinical Evidence ...

Results: The analysis confirms that prebiotic supplementation consistently increased the abundance of beneficial bacteria (e.g., Bifidobacterium ...

Fiber and Prebiotics: Mechanisms and Health Benefits - PMC

Benefits of prebiotics include improvement in gut barrier function and host immunity, reduction of potentially pathogenic bacteria subpopulations (e.g., ...

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, ...

A randomized, placebo-controlled clinical trial

This study aimed to show a causal relationship between microbiome modulation through fibre intervention and health.

Mixing fibers for gut health

Researches in Purdue University's College of Agriculture have discovered that combining specific fibers can have a synergistic effect.

Evaluation of the Gastrointestinal Tolerability of Fibersmart ...

Additionally, GI symptoms did not appear to increase across the escalating doses, which was supported by additional measures of GI tolerability ...

Prebiotic fiber modulation of the gut microbiota improves risk ...

Prebiotic fibers are non-digestible carbohydrates that promote the growth of beneficial bacteria in the gut. Prebiotic consumption may benefit obesity.

GRAS Notice GRN 1045 Agency Response Letter

AGG notes that the Institute for Medicine (IOM, 2005) has not established a tolerable upper limit for dietary fiber and concludes that serious and chronic ...

Anderson Advanced Ingredients' sugar-reduction fiber trial ...

Anderson Advanced Ingredients' sugar-reduction fiber trial showed safety for gastrointestinal tract ... GLP-1 food and gut health. Fibers.