Can a fiber supplement reshape the small Intestine's hidden microbiome?
NCT ID NCT07788924
First seen Aug 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time
Summary
This trial asks whether a daily prebiotic supplement called FiberSmart can change the bacteria living in the small intestine of healthy adults. Researchers will give 30 participants either FiberSmart or a placebo for 21 days. They will use a special capsule to sample the small intestine directly, along with stool samples, to see if the prebiotic shifts the microbial community. The goal is to understand how prebiotics affect the upper gut, which plays a key role in metabolism and immunity.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- FiberSmart, a soluble tapioca fiber powder (resistant dextrin) taken orally as a prebiotic supplement
- What this could lead to
- If it works, this could reveal how prebiotics affect the small intestine, opening the door to targeted gut health products.
- What could go wrong
- This is a small, early-stage trial with only 30 participants, so results may not apply broadly. The prebiotic may also cause mild digestive discomfort.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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19 to 40 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Aged 19-40 years old at the inclusion of the study, both female and male subjects. 2. Either a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to the Baseline Visit. 3. Willing to maintain their current lifestyle during the study. 4. Able to swallow a 25mm length and 9mm width sized capsule. 5. 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.- Page 3 of 5 \[DRAFT\] 6. Signed Informed Consent, and willing to follow the study procedures, including consumption of study product per the protocol and completing any forms/questionnaires needed throughout the study. Exclusion Criteria: 1. Use of any prescription medication within 14 days prior to the start of the study, which in the investigator's opinion, may interfere with the study results or pose a risk to the participant (excluding oral contraceptives). 2. Any current acute or chronic medical condition, which in the investigator's opinion, may interfere with the study results or pose a risk to the participant. 3. Known or suspected history of any gastrointestinal disease including, but not limited to, irritable bowel syndrome, celiac disease (treated or untreated), inflammatory bowel disease, persistent diarrhea, chronic constipation, gastrointestinal malignancy, or any condition known to affect gastrointestinal motility or absorption. 4. Less than 3 bowel movements a week 5. If using Proton Pump Inhibitors (PPIs), unable to stop for PPIs 24hrs prior to SIMBA capsule ingestion and 4 hours after 6. Prior gastrointestinal surgery, or radiation treatment which, in the Investigator's opinion, may lead to intestinal stricturing or obstruction with a risk of capsule non-excretion, including, e.g., untreated achalasia, eosinophilic esophagitis, cancer diagnosis (depending on timing, location, and treatment) or previous esophageal, gastric, small intestinal, or colonic surgery. Appendectomy or cholecystectomy more than 3 months before the screening visit is acceptable. 7. History of known structural gastrointestinal abnormalities such as strictures or fistulas leading to mechanical obstruction. 8. Organic motility disorder (e.g., gastroparesis, intestinal pseudo#obstruction, systemic sclerosis, Ogilvie's syndrome) with a history of swallowing difficulty or oropharyngeal dysphagia. 9. Use of metformin within 3 months prior to the start of the study 10. Use of any oral or intravenous antibiotics within 3 months prior to the baseline study timepoint (topical antibiotics are acceptable). 11. Use of probiotics, prebiotics, fibre (Metamucil, FibreOne, etc.) or any other supplements known to affect the gastrointestinal microbiota within 14 days prior to the baseline study timepoint. 12. Known or suspected allergy or intolerance to the IP or its components. 13. Pregnant or breastfeeding women. 14. Excessive alcohol consumption or drug abuse.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
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Study contacts
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Contact
Email: •••••@•••••
Locations
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Life Science Innovation Hub
Calgary, Canada
Contact Email: •••••@•••••
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