Dietary fibre supplementation to prevent ulcerative colitis relapse: randomised double-blind placebo controlled clinical trial
Completed
- Conditions
- lcerative colitis and proctitis in remissionDigestive SystemUlcerative colitis and proctitis
- Registration Number
- ISRCTN75453816
- Lead Sponsor
- antmännen Food (Sweden)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 130
Inclusion Criteria
1. Adults with ulcerative colitis or proctitis in clinical and endoscopic remisson following a colitis relapse within prior 12 months
2. Written consent
Exclusion Criteria
1. Antibiotics at inclusion
2. Steroids in last two weeks
3. Ongoing treatment with immunosuppressive drugs
4. Pregnancy or planned pregnancy
5. Concomitant serious disorder
6. Inability to comply with study protocol
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Colitis relapse at six months.
- Secondary Outcome Measures
Name Time Method The following will be assessed at six months:<br>1. General health<br>2. Bowel symptoms <br>3. Faecal butyrate concentration