Irritable Bowel Syndrome
Conditions
Keywords
IBS, Irritable bowel syndrome, Probiotics, Treatment, Adequate relief
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.
Interventions
DIETARY_SUPPLEMENTProbiotics
Capsules with probiotics containing the strains : Lactobacillus paracasei ssp paracasei F19, Lactobacillus acidophilus La5 og Bifidobacterium Bb12. Dose/capsule : 2 x 109 - 10 x 109 CFU.
DIETARY_SUPPLEMENTPlacebo
Placebo capsules containing maltodextrin
Sponsors
Mejeribrugets ForskningsFond
Arla Foods
University of Southern Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adequate relief | Every month for 12 months | The patients are asked In the last seven days, have you had adequate relief of your IBS symptoms? . They are asked this question every month ( in a monthly letter) for 12 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| gastrointestinal symptoms | Every month for 12 months | We use the questionnaires GSRS-IBS and GSRS. The patients are asked every month (in monthly letters) for 12 months. |
Countries
Denmark
Outcome results
None listed