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Probiotics for Irritable Bowel Syndrome

Primary Purpose

Functional Gastrointestinal Disorders, Irritable Bowel Syndrome

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
placebo followed by Lactobacillus plantarum MF 1298
Lactobacillus plantarum MF1298 followed by placebo
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Functional Gastrointestinal Disorders focused on measuring Probiotics

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Innlandet Hospital HF

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

placebo followed by probiotic

probiotic followed by placebo

Arm Description

placebo, then washout period, then Lactobacillus plantarum MF1298

Lactobacillus plantarum MF1298, then washout period, then placebo

Outcomes

Primary Outcome Measures

Satisfactory relief of abdominal symptoms
relief of symptoms recorded on diary cards

Secondary Outcome Measures

Graded measurement of abdominal symptoms
IBS sum score
Fecal bacterial count
Abdominal gas
Immunological parameters

Full Information

First Posted
July 24, 2006
Last Updated
July 18, 2016
Sponsor
Norwegian University of Science and Technology
Collaborators
Norwegian Food Research, Gilde, Norwegian Foundation for Health and Rehabilitation, Sykehuset Innlandet HF
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1. Study Identification

Unique Protocol Identification Number
NCT00355810
Brief Title
Probiotics for Irritable Bowel Syndrome
Official Title
Lactobacillus Plantarum MF 1298 vs Placebo for Irritable Bowel Syndrome.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
April 2006 (Actual)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
Norwegian Food Research, Gilde, Norwegian Foundation for Health and Rehabilitation, Sykehuset Innlandet HF

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Gastrointestinal Disorders, Irritable Bowel Syndrome
Keywords
Probiotics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
placebo followed by probiotic
Arm Type
Experimental
Arm Description
placebo, then washout period, then Lactobacillus plantarum MF1298
Arm Title
probiotic followed by placebo
Arm Type
Experimental
Arm Description
Lactobacillus plantarum MF1298, then washout period, then placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo followed by Lactobacillus plantarum MF 1298
Other Intervention Name(s)
probiotic
Intervention Description
placebo during 3 weeks, washout period 4 weeks, Lactobacillus plantarum MF1298 during 3 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Lactobacillus plantarum MF1298 followed by placebo
Other Intervention Name(s)
probiotic
Intervention Description
Lactobacillus plantarum MF1298 during 3 weeks, washout period 4 weeks, placebo during 3 weeks
Primary Outcome Measure Information:
Title
Satisfactory relief of abdominal symptoms
Description
relief of symptoms recorded on diary cards
Time Frame
11 weeks
Secondary Outcome Measure Information:
Title
Graded measurement of abdominal symptoms
Description
IBS sum score
Time Frame
11 weeks
Title
Fecal bacterial count
Time Frame
11 weeks
Title
Abdominal gas
Time Frame
11 weeks
Title
Immunological parameters
Time Frame
11 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Per G Farup, PhD
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Innlandet Hospital HF
City
Gjovik
State/Province
Oppland
ZIP/Postal Code
N-2819
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
20144246
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.
Results Reference
result
PubMed Identifier
22899904
Citation
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. Epub 2012 Jul 31.
Results Reference
result

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Probiotics for Irritable Bowel Syndrome

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