Probiotics for Irritable Bowel Syndrome

Irritable Bowel Syndrome Clinical Trial

Official title:

Lactobacillus Plantarum MF 1298 vs Placebo for Irritable Bowel Syndrome.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00355810
• Other study ID #: REK 4.2005.2284
• Status: Completed
• Phase: N/A
• First received: July 24, 2006
• Last updated: July 18, 2016
• Start date: January 2006
• Est. completion date: December 2006

Study information

• Verified date: July 2016
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research EthicsNorway: Norwegian Social Science Data ServicesNorway: Directorate of Health
• Study type: Interventional

Clinical Trial Summary

This randomised, double blind, cross-over study compares the effect (symptoms, fecal bacterial growth, gas production) of three weeks' treatment with lactobacillus plantarum MF 1298 with placebo in patients with irritable bowel syndrome. The results are related to dietary habits, food intolerance and food allergy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: December 2006
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Irritable bowel syndrome according to the Rome II criteria

• regular symptoms

Exclusion Criteria:

• Use of probiotics last three weeks

• pregnancy

• lactation

• co-existing other gastrointestinal disorders

• use of laxatives and antibiotics within last 5 weeks.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Digestive System Diseases
• Functional Gastrointestinal Disorders
• Gastrointestinal Diseases
• Irritable Bowel Syndrome
• Syndrome

Intervention

Dietary Supplement:
• placebo followed by Lactobacillus plantarum MF 1298
placebo during 3 weeks, washout period 4 weeks, Lactobacillus plantarum MF1298 during 3 weeks
• Lactobacillus plantarum MF1298 followed by placebo
Lactobacillus plantarum MF1298 during 3 weeks, washout period 4 weeks, placebo during 3 weeks

Locations

Country	Name	City	State
Norway	Innlandet Hospital HF	Gjovik	Oppland

Sponsors (5)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Gilde, Norway AB, Norwegian Food Research, Norwegian Foundation for Health and Rehabilitation, Sykehuset Innlandet HF

Country where clinical trial is conducted

Norway, 

References & Publications (2)

Farup PG, Jacobsen M, Ligaarden SC, Rudi K. Probiotics, symptoms, and gut microbiota: what are the relations? A randomized controlled trial in subjects with irritable bowel syndrome. Gastroenterol Res Pract. 2012;2012:214102. doi: 10.1155/2012/214102. Epu — View Citation

Ligaarden SC, Axelsson L, Naterstad K, Lydersen S, Farup PG. A candidate probiotic with unfavourable effects in subjects with irritable bowel syndrome: a randomised controlled trial. BMC Gastroenterol. 2010 Feb 10;10:16. doi: 10.1186/1471-230X-10-16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Satisfactory relief of abdominal symptoms	relief of symptoms recorded on diary cards	11 weeks	No
Secondary	Graded measurement of abdominal symptoms	IBS sum score	11 weeks	No
Secondary	Fecal bacterial count		11 weeks	No
Secondary	Abdominal gas		11 weeks	No
Secondary	Immunological parameters		11 weeks	No