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Gut bacteria may predict who benefits from prebiotics in ulcerative colitis

NCT ID NCT05579483

Disease control Sponsor: Wageningen University Source: ClinicalTrials.gov ↗

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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 20, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This trial tests whether a prebiotic supplement can ease symptoms in people with mild ulcerative colitis, a chronic inflammatory bowel disease. Participants will take either the prebiotic or a placebo for eight weeks. The study aims to see if certain gut bacteria patterns can predict who responds well to the supplement, potentially leading to more personalized dietary advice.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A prebiotic blend of three non-digestible carbohydrates (acacia gum, partially hydrolyzed guar gum, and resistant starch)
What this could lead to
If successful, this could lead to a personalized dietary supplement that helps manage mild ulcerative colitis symptoms based on an individual's gut bacteria.
What could go wrong
This is an early-stage trial with a small number of participants, so results may not apply broadly. The prebiotic may cause digestive discomfort, and its effectiveness is uncertain.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Expected to start

Dec 2023

An estimate. Start dates often move.

Expected to finish

Oct 2025

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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. Male and female subjects aged 18 to 65 years 2. Body Mass Index (BMI) between 18 and 30 kg/m2 (self-reported) 3. Ulcerative Colitis confirmed via previous endoscopy and histology 4. Mild active UC as defined by P-SCCAI score of 3 to 5 (range 0 to 19) 5. Frequent relapse (at least one exacerbation in the last two years) 6. No known allergy to any components of the study product (self-reported) 7. Signed informed consent 8. Stable UC medication defined as no switch to other medication or no dose change 9. Mobile phone on which apps (used for questionnaires) can be downloaded (iOS version 9 and newer, Android version 4.4 and newer. Phones manufactured after 2013 are usually suitable) 10. Stable dietary pattern during the study Exclusion Criteria: 1. Any other underlying disease of the GI-tract or previous bowel surgery, except cholecystectomy and appendectomy 2. Pregnancy or intending to become pregnant during the study 3. Use of medication that can interfere with the study outcomes, as judged by the medical supervisor 4. The need for antibiotic use during the intervention period 5. Systemic antibiotics and proton pump inhibitors (except for omeprazole and pantoprazole with dosage \<20 mg), prebiotic supplements, probiotic supplements four weeks prior to study start 6. Currently participating in another intervention study 7. Acquaintances of anyone in the research team

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Conditions

The condition(s) this trial relates to.

ulcerative colitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ulcerative colitis

Contacts and locations

Locations

  • Wageningen University

    Wageningen, Gelderland, 6708WE, Netherlands

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