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Could a daily fibre supplement ease ulcerative colitis?

NCT ID NCT06515210

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether two types of fibre supplements—acacia gum and microcrystalline cellulose—can reduce gut inflammation in people with ulcerative colitis. Sixty-nine participants will add one of the fibres or a placebo to their usual diet for six weeks. Researchers will measure changes in inflammation (fecal calprotectin) and disease symptoms.

What this could mean

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

Active substance
Acacia gum and microcrystalline cellulose (dietary fibre supplements)
What this could lead to
If it works, this could point toward a simple, personalized dietary supplement strategy to help manage ulcerative colitis inflammation.
What could go wrong
This is a small, early-stage trial (69 people) testing only short-term effects (6 weeks). The fibre supplements may not reduce inflammation or could cause 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

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.

Participants

About 69 people

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

Started

Jun 2025

Expected to finish

Dec 2027

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

14 years and older

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: * Known diagnosis of ulcerative colitis. * Evidence of active disease, defined as either 1) measured FCP \>100 µg/g at screening, OR 2) Partial Mayo Scoring Index Assessment for UC ≥2 (adult patients) OR Pediatric UC Activity Index (PUCAI) ≥10 (pediatric patients). Patients who are in clinical remission (Partial Mayo \<2 or PUCAI \<10) that have active inflammation (elevated FCP \>100 µg/g) would also be eligible, as will patients with active symptoms, regardless of availability of FCP. * Tanner stage ≥4 for pediatric patients. * Weight \>40kg. * No changes to IBD-related medications in three months prior to study onset (stable therapy, including use of 5-aminosalicylic acid, biologics, and immunosuppressive medications; some minor adjustments allowed, such as increasing dose for weight change, or change to a compatible/generic treatment). * Men and women that use adequate contraceptive methods. * Able to maintain current lifestyle (diet, exercise, supplements/medications, and sleep) throughout study. Exclusion Criteria: * Inability to provide informed consent. * Presence of Crohn disease, IBD unclassified, non-IBD bowel conditions (e.g., celiac), or motility disorder. * Presence of abnormal constrictions of the gastrointestinal tract, diseases of the esophagus and/or the superior opening of the stomach (cardia), potential or existing intestinal blockage, paralysis of the intestine, megacolon, fecal impaction, inflamed bowel or appendicitis, or have failed to defecate after taking another laxative. * History of significant chronic disorders such as severe cardiac disease, malignancy requiring systemic chemotherapy or radiation therapy, significant renal failure, severe pulmonary disease, kidney disorders, diabetes, arthritis, multiple sclerosis, or other immune-mediated conditions requiring systemic therapy. * Presence of serious infection (e.g., infectious colitis). * Presence of severe anemia, defined as hemoglobin \<100 g/L or considered clinically significant based on physician discretion. * Presence of disease or condition that negatively impacts ability to swallow, which may interfere with intake of supplement. * Use of systemic antibiotics for more than a week during two months prior to intervention, or any antibiotic use during the intervention. * Use of medications that inhibit peristaltic movement (e.g. opioids, loperamide) * Consistent use of topical therapies (e.g., rectal suppositories, enemas) for at least a week, with a resulting improvement in symptoms (defined based on physician discretion). * Use of probiotic, prebiotic, or fibre supplements in month prior to intervention or during the course of the trial that are known to affect the gut microbiome (if these are present in foods, such as yogurt or fermented foods, this will be allowed). * Chronic use of laxatives, stool softeners, or anti-diarrheal medications. * Chronic use of illicit drugs and/or excessive alcohol (e.g., average of \>7 drinks/week). * Current smoker (cigarettes). * History of abdominal surgery, including appendectomy. * Pregnancy or intention of the patient to become pregnant during the study period. * Breastfeeding. * Allergy to any ingredients of investigational products or placebo (i.e., acacia gum, microcrystalline cellulose, or maltodextrin). * Unable to maintain high fiber intake through supplementation during intervention.

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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.

  1. The places running it

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

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • University of Alberta Hospital

    RECRUITING

    Edmonton, Alberta, T6G 2X8, Canada

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