Testing Acacia Gum against a placebo for ulcerative colitis
Official title: Personalized Anti-Inflammatory Fibres in Ulcerative Colitis
Clinical Profiling of Anti-inflammatory Fibre Supplements in Patients With Ulcerative Colitis: Towards Personalized Complementary Strategies.
Interventions
Acacia Gum
Participants (n=23) incorporate the fibre supplement into their usual diet daily.
Microcrystalline Cellulose
Participants (n=23) incorporate the fibre supplement into their usual diet daily.
Placebo
Participants (n=23) incorporate the placebo into their usual diet daily.
Canadian Sites (1)
University of Alberta Hospital
Edmonton, Alberta, Canada
Eligibility Criteria
See who this study is looking for26 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Tanner stage ≥4 for pediatric patients.
- +Known diagnosis of ulcerative colitis.
- +Evidence of active disease, defined as either 1) measured FCP \>100 µg/g at screeningScreeningThe checks done before joining, to see whether a study fits.Read more →, 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.
- +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).
- +Able to maintain current lifestyle (diet, exercise, supplements/medications, and sleep) throughout study.
- +Men and women that use adequate contraceptive methods.
Exclusion
- −Allergy to any ingredients of investigational products or placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → (i.e., acacia gum, microcrystalline cellulose, or maltodextrin).
- −Inability to provide informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →.
- −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.
- −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).
- −Unable to maintain high fiber intake through supplementation during intervention.
- −Pregnancy or intention of the patient to become pregnant during the study period.
- −Breastfeeding.
- −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.
- −History of abdominal surgery, including appendectomy.
- −Current smoker (cigarettes).
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
What is being given or done in this study: Acacia Gum, Microcrystalline Cellulose, PlaceboPlaceboA dummy treatment with no active medicine, used for comparison.Read more →.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
Neither you nor the study team would know which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
There are 3 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists a minimum age of 14 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 69 people.
The study is currently expected to finish around December 2027.
The main measurement is taken over: Week 3 and Week 6 (and week 12, if applicable).
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Changes in fecal calprotectin — measured over Week 3 and Week 6 (and week 12, if applicable).
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06515210 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Acacia GumDietary supplement
Participants (n=23) incorporate the fibre supplement into their usual diet daily.
From the trial registry — its own words, unedited.
What a dietary supplement is here: A vitamin, mineral, or other supplement being studied.
Read the full explanation → · in clinical review
About Microcrystalline CelluloseDietary supplement
Participants (n=23) incorporate the fibre supplement into their usual diet daily.
From the trial registry — its own words, unedited.
What a dietary supplement is here: A vitamin, mineral, or other supplement being studied.
Read the full explanation → · in clinical review
About PlaceboDietary supplement
Participants (n=23) incorporate the placebo into their usual diet daily.
From the trial registry — its own words, unedited.
What a dietary supplement is here: A vitamin, mineral, or other supplement being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 14 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
Neither you nor the study team would know which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 14 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Week 3 and Week 6 (and week 12, if applicable).
The study as a whole is currently expected to finish around 2027-12.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 69 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Edmonton, Alberta, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
The goal of this clinical trial is to determine the clinical effects of two different dietary fibre supplements, acacia gum (AG) and microcrystalline cellulose (MCC), in patients with ulcerative colitis. The main question it aims to answer is: Can the fibre supplements reduce gut inflammation (fecal calprotectin)? Researchers will compare AG and MCC to a placebo (a look-alike substance that contains no fibre) to see if the fibre supplements improve inflammation in ulcerative colitis. Participants will add their assigned fibre supplement or placebo to their usual diet daily for 6 weeks. They will visit the clinic at baseline, week 3, and week 6 to provide samples (stool, blood) and complete various questionnaires.
Think this trial might be right for you?
Complete a quick intake form and we will match you with this and other relevant trials based on your medical profile.
See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.