FiberSmart for Gut Microbiome Health
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants ingest either the FiberSmart or a matched Placebo daily for 21 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
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
Find a Clinic Near You
Who Is Running the Clinical Trial?
Nimble Science Ltd.
Lead Sponsor
Anderson Advanced Ingredients
Industry Sponsor
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 ...
9.
foodingredientsfirst.com
foodingredientsfirst.com/news/anderson-advanced-ingredients-sugar-reduction-fiber-trial-showed-safety-for-gastrointestinal-tract.htmlAnderson 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.
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.