Condition category
Digestive System
Date applied
04/02/2008
Date assigned
20/03/2008
Last edited
20/03/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Claes Hallert

ORCID ID

Contact details

Norrköping Hospital NSÖ stab
Norrköping
S-60182
Sweden
+46 (0)70 543 8282
Claes.Hallert@telia.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

v.13

Study information

Scientific title

Acronym

Study hypothesis

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

Ethics approval received from the ethics committee of Linköping University, Sweden (ref: M 159-04)

Study design

Randomised double-blind placebo controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet (only in Swedish)

Condition

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 names

Oat bran

Primary outcome measures

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 trial start date

15/10/2006

Overall trial end date

20/07/2009

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

130

Participant 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

Recruitment start date

15/10/2006

Recruitment end date

20/07/2009

Locations

Countries of recruitment

Sweden

Trial participating centre

Norrköping Hospital NSÖ stab
Norrköping
S-60182
Sweden

Sponsor information

Organisation

Lantmännen Food (Sweden)

Sponsor details

c/o Dr Ingmar Börjesson
R&D Department
Järna
153 81
Sweden
+46 (0)8 519 787 00
ingmar.borjesson@lantmannen.com

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Lantmannen Food R&D (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Medical Research Council of South-East Sweden (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes