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

January 28, 2013 updated by: Maastricht University Medical Center

The Effect of a Multispecies Probiotic on Hypersensitivity in IBS Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Maastricht, Netherlands
        • University Hospital Maastricht

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Dietary supplement: multispecies probiotic (Ecologic 801)
once daily, 5 gram [10e9 cfu/gram]
Other Names:
  • Ecologic 801
Placebo Comparator: 2
Dietary supplement: Placebo
once daily, 5 gram [10e9 cfu/gram]

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain tolerance threshold
Time Frame: t=0 and t=6 weeks
t=0 and t=6 weeks
VAS score for pain at pressure step 29 mmHg
Time Frame: t=0 and t=6 weeks
t=0 and t=6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Collaborators

Winclove Bio Industries BV

Investigators

  • Principal Investigator: A AM Masclee, Prof. Dr., Maastricht University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

June 11, 2008

First Submitted That Met QC Criteria

June 18, 2008

First Posted (Estimate)

June 19, 2008

Study Record Updates

Last Update Posted (Estimate)

January 29, 2013

Last Update Submitted That Met QC Criteria

January 28, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEC 08-1-031

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe