Clinical trial NCT01151657: Probiotics for Irritable Bowel Syndrome
Official title: Probiotics for Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Keywords: IBS
Irritable bowel syndrome
Probiotics
Treatment
Adequate relief
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Mejeribrugets ForskningsFond
name: Arla Foods
First posted: 2010-06-28
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims to investigate the effect of probiotics on IBS-patients symptoms compared to placebo, when given for 6 months.

By draw the investigators give IBS patients, in the age of 18-50 years, capsules with either probiotics or placebo. The patients are to take 2x2 capsules / day for 6 months. The patients are followed for 1 year. They are seen after 3, 6 and 12 months, and are followed by means of monthly letters.

The capsules contain 3 different probiotic strains - Lactobacillus paracasei ssp paracasei F19, Lactobacillus acidophilus La5 and Bifidobacterium Bb12. The dose is 2 x 109 - 10 x 109 CFU/capsule.

The hypothesis is, that there is a clinical difference between the group receiving probiotics and the group receiving placebo.

Detailed description: Background: In management of IBS, no treatments have showed great efficacy. IBS is a non-fatal disease, so safety is a high priority in the choice of treatment. Probiotics is a dietary supplement and have no adverse effects. In some studies it has shown beneficial effect on some of the IBS patients symptoms, but some of the results are questionable. The studies have to be of longer duration, with more patients and the probiotics have to be capsules instead of milk based drinks.

Eligibility criteria: Inclusion Criteria:

* Fulfill ROME III criteria
* age 18-50 years
* signed informed content

Exclusion Criteria:

* Danger signals (fever, anaemia, weightloss, blod in stools, predisposition for CRC or IBD)
* abnormal physical examination
* comorbidity
* abuse
* lacking ability to talk and understand danish
* pregnancy
* For patients \> 40 years. Changed bowel habits, with duration \> 3 weeks, but \< 1 year

Primary outcomes:
measure: Adequate relief
timeFrame: Every month for 12 months
Secondary outcomes:
measure: gastrointestinal symptoms
timeFrame: Every month for 12 months
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Research Unit for General Practice, Department of gastroenterology, Odense University hospital
Study officials:
affiliation: Department of gastroenterology, Odense University hospital
name: Ove B Schaffalitzky de Muckadell, Dr.Med, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Begtrup LM, de Muckadell OB, Kjeldsen J, Christensen RD, Jarbol DE. Long-term treatment with probiotics in primary care patients with irritable bowel syndrome--a randomised, double-blind, placebo controlled trial. Scand J Gastroenterol. 2013 Oct;48(10):1127-35. doi: 10.3109/00365521.2013.825314. Epub 2013 Aug 19.