The Effect of a Multispecies Probiotic on Hypersensitivity in Irritable Bowel Syndrome (IBS) Patients

Not Applicable

Completed

• Conditions: Irritable Bowel Syndrome; Hypersensitivity
• Interventions: Dietary Supplement: multispecies probiotic (Ecologic 801); Dietary Supplement: Placebo

• Registration Number: NCT00702026
• Lead Sponsor: Maastricht University Medical Center

Brief Summary

The purpose of this study is to determine whether a specifically designed multispecies probiotic decreases visceral hypersensitivity in IBS-patient (defined by an increased pain tolerance threshold). Moreover, the effect on general symptom scores and inflammatory and microbiological parameters will be studied.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-06-11
• Study First Submitted QC: 2008-06-18
• Study First Posted: 2008-06-19
• Study Start: 2008-08
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-28
• Last Update Posted: 2013-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Clinical diagnosis of IBS according to the Rome III criteria
• Increased visceral perception according to barostat measurements, defined as a pain tolerance threshold at smaller than or equal to 23 mmHg
• Age between 18 and 65 years
• BMI between 18.5 and 30 kg/m2

Exclusion Criteria

• Known gastro-intestinal diseases
• Major abdominal surgery
• Previous radiotherapy, chemotherapy
• Clinical significant systemic diseases
• Critically ill patients or patients suffering from severe acute pancreatitis
• Patients with organs failure
• Patients receiving enteral feeding
• Excessive alcohol intake (greater than 15 consumptions per week)
• (planned) pregnancy or lactation
• Use of pre-, probiotics in the month before and during the study
• Use of antibiotics in the two months before and during the study
• Use of anti-diarrhoea medication, anti-laxatives or anti-acid medication in the two weeks before and during the study
• Use of anti depressives (especially SSRI's) in the month before and during the study
• Use of other medication if less then one month on stable dosage

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	multispecies probiotic (Ecologic 801)	-
2	Placebo	-

Primary Outcome Measures

Name	Time	Method
Pain tolerance threshold	t=0 and t=6 weeks
VAS score for pain at pressure step 29 mmHg	t=0 and t=6 weeks

Trial Locations

Locations (1)

University Hospital Maastricht; 🇳🇱 Maastricht, Netherlands