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New treatment option for Inflammatory Bowel Diseases
Official title Personalized B-fructan Diet in Inflammatory Bowel Disease Patients
ClinicalTrials.gov ID: NCT05615779
What this study is testing
- What it's testing
- This study aims to examine patient tolerability of personalized dietary fibre consumption recommendations (high-pectin diet versus high-B-fructan diet based on personalized responses), provided by an IBD dietician, based on our novel translational research findings.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 39. Healthy volunteers may be eligible.
You may be able to join if
- Children (age 6-17) or young adults (age 18-39).
- Known or suspected UC or IBDU [there will be 2 control group: non-IBD (undergoing colonoscopy but found not to have IBD; and healthy (no GI symptoms...
- For UC: Remission-mild-moderate disease: Mayo score \<10
- Clinical indication for sedated colonoscopy
- Disease location: E2-E4
You likely can't join if
- Use of antibiotics for a week or more over the last 3 months
- Use of probiotics or prebiotics at pharmacological doses (adding fibre sources to food or probiotics in yogurt, for example, are allowed)
- History of abdominal surgery, including appendectomy
- Documented enteric infection during the 3 months prior to endoscopy
- Presence of non-IBD bowel conditions (e.g., celiac), anatomical or mucosal abnormalities, motility disorder
- Presence of a systemic disease requiring treatment (cancer, ischemic heart disease, kidney failure, etc)
See the full eligibility criteria
- Children (age 6-17) or young adults (age 18-39).
- Known or suspected UC or IBDU [there will be 2 control group: non-IBD (undergoing colonoscopy but found not to have IBD; and healthy (no GI symptoms, so not required to have colonoscopy; could be family members)]
- For UC: Remission-mild-moderate disease: Mayo score \<10
- Clinical indication for sedated colonoscopy
- Disease location: E2-E4
- Stable treatment (not on steroids; biologics or immunomodulator not changed in last month)
- High likelihood that patients will be able to collect all samples and provide all data
- Use of antibiotics for a week or more over the last 3 months
- Use of probiotics or prebiotics at pharmacological doses (adding fibre sources to food or probiotics in yogurt, for example, are allowed)
- History of abdominal surgery, including appendectomy
- Documented enteric infection during the 3 months prior to endoscopy
- Presence of non-IBD bowel conditions (e.g., celiac), anatomical or mucosal abnormalities, motility disorder
- Presence of a systemic disease requiring treatment (cancer, ischemic heart disease, kidney failure, etc)
- Proctitis (E1)
- Systemic steroids (above 10 mg/day of Prednisone)
- Topical therapy within 1 week of endoscopy
- Recent change in IBD treatment (started biologics or IM over the last month)
- Pregnancy or planning to become pregnant during the study
- Inability to understand or sign the consent
The study team makes the final eligibility decision.
Where it's taking place
- Edmonton, Alberta, Canada
- Winnipeg, Manitoba, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 39 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Edmonton, Alberta, Canada; Winnipeg, Manitoba, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.