Probiotics for Irritable Bowel Syndrome

NCT ID: NCT00355810

Last Updated: 2016-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2006-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Functional Gastrointestinal Disorders Irritable Bowel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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placebo followed by probiotic

placebo, then washout period, then Lactobacillus plantarum MF1298

Group Type EXPERIMENTAL

placebo followed by Lactobacillus plantarum MF 1298

Intervention Type DIETARY_SUPPLEMENT

placebo during 3 weeks, washout period 4 weeks, Lactobacillus plantarum MF1298 during 3 weeks

probiotic followed by placebo

Lactobacillus plantarum MF1298, then washout period, then placebo

Group Type EXPERIMENTAL

Lactobacillus plantarum MF1298 followed by placebo

Intervention Type DIETARY_SUPPLEMENT

Lactobacillus plantarum MF1298 during 3 weeks, washout period 4 weeks, placebo during 3 weeks

Interventions

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placebo followed by Lactobacillus plantarum MF 1298

placebo during 3 weeks, washout period 4 weeks, Lactobacillus plantarum MF1298 during 3 weeks

Intervention Type DIETARY_SUPPLEMENT

Lactobacillus plantarum MF1298 followed by placebo

Lactobacillus plantarum MF1298 during 3 weeks, washout period 4 weeks, placebo during 3 weeks

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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probiotic probiotic

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Norwegian Food Research

UNKNOWN

Sponsor Role collaborator

Gilde

OTHER

Sponsor Role collaborator

Norwegian Foundation for Health and Rehabilitation

OTHER

Sponsor Role collaborator

Sykehuset Innlandet HF

OTHER

Sponsor Role collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Per G Farup, PhD

Role: PRINCIPAL_INVESTIGATOR

Norwegian University of Science and Technology

Locations

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Innlandet Hospital HF

Gjøvik, Oppland, Norway

Site Status

Countries

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Norway

References

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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.

Reference Type RESULT
PMID: 20144246 (View on PubMed)

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.

Reference Type RESULT
PMID: 22899904 (View on PubMed)

Other Identifiers

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REK 4.2005.2284

Identifier Type: -

Identifier Source: org_study_id

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