Can a fiber supplement reshape the small Intestine's hidden microbiome?

NCT ID NCT07788924

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

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

19 to 40 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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

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  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

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Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Life Science Innovation Hub

    Calgary, Canada

    Contact Email: •••••@•••••

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