FindTrial
Sign In

Probiotics for Irritable Bowel Syndrome

Lactobacillus Plantarum MF 1298 vs Placebo for Irritable Bowel Syndrome.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00355810
Enrollment
19
Registered
2006-07-25
Start date
2006-01-31
Completion date
2006-12-31
Last updated
2016-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional Gastrointestinal Disorders, Irritable Bowel Syndrome

Keywords

Probiotics

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.

Interventions

DIETARY_SUPPLEMENTplacebo followed by Lactobacillus plantarum MF 1298

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

DIETARY_SUPPLEMENTLactobacillus plantarum MF1298 followed by placebo

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

Sponsors

Norwegian Food Research
CollaboratorUNKNOWN
Gilde
CollaboratorOTHER
Norwegian Foundation for Health and Rehabilitation
CollaboratorOTHER
Sykehuset Innlandet HF
CollaboratorOTHER
Norwegian University of Science and Technology
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Satisfactory relief of abdominal symptoms11 weeksrelief of symptoms recorded on diary cards

Secondary

MeasureTime frameDescription
Abdominal gas11 weeks—
Immunological parameters11 weeks—
Fecal bacterial count11 weeks—
Graded measurement of abdominal symptoms11 weeksIBS sum score

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026