Inflammatory Bowel DiseasesNCT05615779
Personalized B-fructan Diet in Inflammatory Bowel Disease Patients
A study testing Randomized B-fructan diet, Personalized pectin diet and Personalized B-fructan diet in people with Inflammatory Bowel Diseases and Ulcerative Colitis, run by University of Manitoba at 2 sites in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Diseases, Ulcerative Colitis
- What is being tested?
- Randomized B-fructan diet, Personalized pectin diet and Personalized B-fructan diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Aug 2023to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 39 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Eytan Wine, MD, PhD contact
Canada2 sites, 2 recruiting
- Recruiting
University of Alberta Hospital
Edmonton, Alberta, T6G 1C9
Eytan Wine, MD, PhD, 780-407-3339, wine@ualberta.ca
- Recruiting
Health Sciences Centre Hospital
Winnipeg, Manitoba, R3E 3P4
Heather Armstrong, PhDMED, 2047893815, heather.armstrong@umanitoba.ca
About this study
Official title: The Fibre Study: RCT of Personalized Fibre Diet in IBD
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.
- Conditions
- Inflammatory Bowel Diseases, Ulcerative Colitis
- Being tested
- Placebo Comparator: Randomized pectin diet, Randomized B-fructan diet, Personalized pectin diet, Personalized B-fructan diet
- Medical subject headings
- Inflammatory Bowel Diseases, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo Comparator: Randomized pectin dietOther
UC and healthy control participants randomized to receive recommendations provided by a dietician increasing consumption of foods high in pectin
Randomized B-fructan dietOther
UC and healthy control participants randomized to receive recommendations provided by a dietician increasing consumption of foods high in B-fructan
Personalized pectin dietOther
UC and healthy control participants to receive recommendations provided by a dietician increasing consumption of foods high in pectin based on personal host (biopsy) and microbe (stool) response at baseline
Personalized B-fructan dietOther
UC and healthy control participants to receive recommendations provided by a dietician increasing consumption of foods high in B-fructan based on personal host (biopsy) and microbe (stool) response at baseline
| Study group | Role | What they receive |
|---|---|---|
| Randomized pectin diet | Placebo comparator | Not described Receives: Other: Placebo Comparator: Randomized pectin diet |
| Randomized B-fructan diet | Placebo comparator | Not described Receives: Other: Randomized B-fructan diet |
| Personalized pectin diet | Experimental | Not described Receives: Other: Personalized pectin diet |
| Personalized B-fructan diet | Experimental | Not described Receives: Other: Personalized B-fructan diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diet tolerability
Percentage of patients able to tolerate a personalized fiber diet provided by a dietitian will be evaluated at week 4 by measure of patient symptom score (PROMIS questionnaire) and willingness to continue adherence to diet advice provided.
Measured: 4 weeks
Secondary outcomes (2)
Inflammatory response to diet
Host inflammatory response to personalized dietary fibre recommendations provided by dietitian will be determined by examining changes in markers of inflammation in blood and stool
Measured: 1 week, 4 weeks, 8 weeks, 12 weeks
Microbiota changes in response to diet
Host microbiota response to personalized dietary fibre recommendations provided by dietitian will be determined by examining changes in microbe abundance, diversity and functions by shotgun metagenomics in stool
Measured: 1 week, 4 weeks, 8 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start1 Aug 2023
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05615779
- Sponsor's protocol ID
- B2022:074
- Status last verified
- Dec 2024
- First submitted
- 4 Oct 2022
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Fibre Study: RCT of Personalized Fibre Diet in IBD
- ClinicalTrials.gov ID
- NCT05615779
- Acronym / sponsor ID
- B2022:074
- Conditions
- Inflammatory Bowel Diseases, Ulcerative Colitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 14 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Randomized pectin diet | Placebo comparator | Other: Placebo Comparator: Randomized pectin diet |
| Randomized B-fructan diet | Placebo comparator | Other: Randomized B-fructan diet |
| Personalized pectin diet | Experimental | Other: Personalized pectin diet |
| Personalized B-fructan diet | Experimental | Other: Personalized B-fructan diet |
Who may qualify
- Ages
- 6 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo Comparator: Randomized pectin dietUC and healthy control participants randomized to receive recommendations provided by a dietician increasing consumption of foods high in pectin | Other | Randomized pectin diet |
| Randomized B-fructan dietUC and healthy control participants randomized to receive recommendations provided by a dietician increasing consumption of foods high in B-fructan | Other | Randomized B-fructan diet |
| Personalized pectin dietUC and healthy control participants to receive recommendations provided by a dietician increasing consumption of foods high in pectin based on personal host (biopsy) and microbe (stool) response at baseline | Other | Personalized pectin diet |
| Personalized B-fructan dietUC and healthy control participants to receive recommendations provided by a dietician increasing consumption of foods high in B-fructan based on personal host (biopsy) and microbe (stool) response at baseline | Other | Personalized B-fructan diet |
Primary outcome
Diet tolerability
Time frame: 4 weeks
Percentage of patients able to tolerate a personalized fiber diet provided by a dietitian will be evaluated at week 4 by measure of patient symptom score (PROMIS questionnaire) and willingness to continue adherence to diet advice provided.
2 secondary outcomes
Inflammatory response to diet
Time frame: 1 week, 4 weeks, 8 weeks, 12 weeks
Microbiota changes in response to diet
Time frame: 1 week, 4 weeks, 8 weeks, 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eytan Wine, MD, PhD contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Randomized B-fructan diet, Personalized pectin diet and Personalized B-fructan diet in people with Inflammatory Bowel Diseases and Ulcerative Colitis, run by University of Manitoba at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heather Armstrong, MSc, PhD (2047893815, heather.armstrong@umanitoba.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diet tolerability (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.