Dietary fibre supplementation to prevent ulcerative colitis relapse: randomised double-blind placebo controlled clinical trial
| ISRCTN | ISRCTN75453816 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75453816 |
| Secondary identifying numbers | v.13 |
- 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
| Study design | Randomised double-blind placebo controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet (only in Swedish) |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Oat bran |
| Primary outcome measure | Colitis relapse at six months. |
| Secondary outcome measures | The following will be assessed at six months: 1. General health 2. Bowel symptoms 3. Faecal butyrate concentration |
| Overall study start date | 15/10/2006 |
| Completion date | 20/07/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
Sponsor information
Lantmännen Food (Sweden)
Industry
Industry
c/o Dr Ingmar Börjesson
R&D Department
Järna
153 81
Sweden
| Phone | +46 (0)8 519 787 00 |
|---|---|
| ingmar.borjesson@lantmannen.com |
Funders
Funder type
Industry
Lantmannen Food R&D (Sweden)
No information available
Medical Research Council of South-East Sweden (Sweden)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
