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Probiotics for Irritable Bowel Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00355810
Recruitment Status : Completed
First Posted : July 25, 2006
Last Update Posted : July 19, 2016
Sponsor:
Collaborators:
Norwegian Food Research
Gilde
Norwegian Foundation for Health and Rehabilitation
Sykehuset Innlandet HF
Information provided by (Responsible Party):
Norwegian University of Science and Technology

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.

Condition or disease Intervention/treatment Phase
Functional Gastrointestinal Disorders Irritable Bowel Syndrome Dietary Supplement: placebo followed by Lactobacillus plantarum MF 1298 Dietary Supplement: Lactobacillus plantarum MF1298 followed by placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Lactobacillus Plantarum MF 1298 vs Placebo for Irritable Bowel Syndrome.
Study Start Date : January 2006
Actual Primary Completion Date : April 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: placebo followed by probiotic
placebo, then washout period, then Lactobacillus plantarum MF1298
Dietary Supplement: placebo followed by Lactobacillus plantarum MF 1298
placebo during 3 weeks, washout period 4 weeks, Lactobacillus plantarum MF1298 during 3 weeks
Other Name: probiotic

Experimental: probiotic followed by placebo
Lactobacillus plantarum MF1298, then washout period, then placebo
Dietary Supplement: Lactobacillus plantarum MF1298 followed by placebo
Lactobacillus plantarum MF1298 during 3 weeks, washout period 4 weeks, placebo during 3 weeks
Other Name: probiotic




Primary Outcome Measures :
  1. Satisfactory relief of abdominal symptoms [ Time Frame: 11 weeks ]
    relief of symptoms recorded on diary cards


Secondary Outcome Measures :
  1. Graded measurement of abdominal symptoms [ Time Frame: 11 weeks ]
    IBS sum score

  2. Fecal bacterial count [ Time Frame: 11 weeks ]
  3. Abdominal gas [ Time Frame: 11 weeks ]
  4. Immunological parameters [ Time Frame: 11 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00355810


Locations
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Norway
Innlandet Hospital HF
Gjovik, Oppland, Norway, N-2819
Sponsors and Collaborators
Norwegian University of Science and Technology
Norwegian Food Research
Gilde
Norwegian Foundation for Health and Rehabilitation
Sykehuset Innlandet HF
Investigators
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Principal Investigator: Per G Farup, PhD Norwegian University of Science and Technology
Publications of Results:
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Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00355810    
Other Study ID Numbers: REK 4.2005.2284
First Posted: July 25, 2006    Key Record Dates
Last Update Posted: July 19, 2016
Last Verified: July 2016
Keywords provided by Norwegian University of Science and Technology:
Probiotics
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Digestive System Diseases
Gastrointestinal Diseases
Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases