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

This study has been completed.
Sponsor:
Collaborator:
Winclove Bio Industries BV
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00702026
First received: June 11, 2008
Last updated: January 28, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Irritable Bowel Syndrome
Hypersensitivity
Dietary Supplement: multispecies probiotic (Ecologic 801)
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of a Multispecies Probiotic on Hypersensitivity in IBS Patients

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Pain tolerance threshold [ Time Frame: t=0 and t=6 weeks ] [ Designated as safety issue: No ]
  • VAS score for pain at pressure step 29 mmHg [ Time Frame: t=0 and t=6 weeks ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: August 2008
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Dietary Supplement: multispecies probiotic (Ecologic 801)
once daily, 5 gram [10e9 cfu/gram]
Other Name: Ecologic 801
Placebo Comparator: 2 Dietary Supplement: Placebo
once daily, 5 gram [10e9 cfu/gram]

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00702026

Locations
Netherlands
University Hospital Maastricht
Maastricht, Netherlands
Sponsors and Collaborators
Maastricht University Medical Center
Winclove Bio Industries BV
Investigators
Principal Investigator: A AM Masclee, Prof. Dr. Maastricht University Medical Center
  More Information

No publications provided by Maastricht University Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT00702026     History of Changes
Other Study ID Numbers: MEC 08-1-031
Study First Received: June 11, 2008
Last Updated: January 28, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
Irritable Bowel Syndrome
Hypersensitivity
Probiotics
Multispecies

Additional relevant MeSH terms:
Hypersensitivity
Irritable Bowel Syndrome
Immune System Diseases
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 20, 2014