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Completed

NCT Number: NCT01151657

Probiotics for Irritable Bowel Syndrome

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.

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Research Unit for General Practice, Department of gastroenterology, Odense University hospital

Odense, 5000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotics

Dietary Supplement

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.

Placebo

Dietary Supplement

Placebo capsules containing maltodextrin

Primary outcomes

  1. Adequate relief

    Time frame: 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 outcomes

  1. gastrointestinal symptoms

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Collaborators

  • Arla Foods
  • Mejeribrugets ForskningsFond

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jun 28, 2010
Registry last updated
Oct 25, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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