Dietary fibre supplementation to prevent ulcerative colitis relapse: randomised double-blind placebo controlled clinical trial
| ISRCTN | ISRCTN75453816 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75453816 |
| Protocol serial number | v.13 |
| Sponsor | Lantmännen Food (Sweden) |
| Funders | Lantmannen Food R&D (Sweden), Medical Research Council of South-East Sweden (Sweden) |
- Submission date
- 04/02/2008
- Registration date
- 20/03/2008
- Last edited
- 20/03/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Claes Hallert
Scientific
Scientific
Norrköping Hospital NSÖ stab
Norrköping
S-60182
Sweden
| Phone | +46 (0)70 543 8282 |
|---|---|
| Claes.Hallert@telia.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double-blind placebo controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | |
| Study objectives | By taking 60 g of oat bran daily the relapse rate of patients with ulcerative colitis will be lowered from 40% to 20% at six months. |
| Ethics approval(s) | Ethics approval received from the ethics committee of Linköping University, Sweden (ref: M 159-04) |
| Health condition(s) or problem(s) studied | Ulcerative colitis and proctitis in remission |
| Intervention | 60 g of oat bran to the daily diet for six months versus no intervention. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Oat bran |
| Primary outcome measure(s) |
Colitis relapse at six months. |
| Key secondary outcome measure(s) |
The following will be assessed at six months: |
| Completion date | 20/07/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 130 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 15/10/2006 |
| Date of final enrolment | 20/07/2009 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Norrköping Hospital NSÖ stab
Norrköping
S-60182
Sweden
S-60182
Sweden
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
