Ulcerative Colitis Relapse Prevention by Prebiotics

• Register: ClinicalTrials.gov
• Last refreshed on: 19 April 2022
• Main ID: NCT02865707
• Date of registration: 12/07/2016
• Prospective Registration: Yes
• Primary sponsor: University of Alberta
• Public title: Ulcerative Colitis Relapse Prevention by Prebiotics
• Scientific title: Prevention of Ulcerative Colitis by Prebiotics: Efficacy and Protective Mechanisms
• Date of first enrolment: August 2016
• Target sample size: 89
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02865707
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Participant, Investigator).
• Phase: N/A

Countries of recruitment

Canada

Contacts

• Name: Levinus A Dieleman, MD, PhD
• Affiliation: University of Alberta

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients with Ulcerative colitis (UC) with confirmed diagnosis by histology and
endoscopy.

- Currently in clinical remission defined as total Mayo score of = 2 and endoscopic
score of 0 or 1) who have experienced at least one flare in the past 18 months.

- On stable doses of oral 5-ASA for 2 weeks and/or a stable doses of azathioprine and/or
anti-tumor necrosis factor (anti-TNF) biologics for 2 months

- Colonic involvement of >15 cm from the anal verge.

- Ability to give valid informed consent

- For females of child bearing potential, a negative pregnancy test and an agreement to
use appropriate birth control over the study period.

Exclusion Criteria:

- Crohn's disease, indetermined colitis or infectious colitis.

- Active UC, (total Mayo score of = 3)

- Taking prednisone (or steroid equivalent) within 1 month of enrollment

- Used topical 5-ASA or steroids within 2 weeks of enrollment

- Using immunosuppressive treatments of 6-mercaptopurine or methotrexate

- Used antibiotics within 2 months

- Used anti-diarreal agents with the previous 3 days

- Pregnancy or lactation

- Significant chronic disorders such as severe cardiac disease, significant renal
failure, severe pulmonary disease (need for oxygen)

- Active gastrointestinal infection

- Severe psychiatric disorder

- Not able to consent to the study.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Intervention(s)

Dietary Supplement: Synergy-1

Dietary Supplement: Maltodextrin

Primary Outcome(s)

Prevention of relapse [Time Frame: 6 months]

Secondary Outcome(s)

Patient compliance [Time Frame: 3 and 6 month]

Changes in partial Mayo score [Time Frame: 0 and 6 month]

Patient tolerability [Time Frame: 3 and 6 month]

Changes in endoscopic disease activity inflammation [Time Frame: 0 and 6 month]

Time to relapse [Time Frame: 6 months]

Changes in fecal calprotectin [Time Frame: 0, 1, 3 and 6 month]

Secondary ID(s)

Pro00041938

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of British Columbia