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

This study is not yet open for participant recruitment.

Verified by Maastricht University Medical Center, June 2008

Sponsors and Collaborators:	Maastricht University Medical Center Winclove Bio Industries BV
Information provided by:	Maastricht University Medical Center
ClinicalTrials.gov Identifier:	NCT00702026

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

MedlinePlus related topics: Allergy Dietary Supplements

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	The Effect of a Multispecies Probiotic on Hypersensitivity in IBS Patients

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 ]

Estimated Enrollment:	34
Study Start Date:	August 2008
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Dietary Supplement: multispecies probiotic (Ecologic 801) once daily, 5 gram [10e9 cfu/gram]
2: Placebo Comparator	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

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

Contacts

Contact: Catherina JM Koning, MSC

31-43-388-1982

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

Responsible Party:	University Hospital Maastricht, Division of Gastroenterology-Hepatology ( Prof. Dr. A.A.M. Masclee )
Study ID Numbers:	MEC 08-1-031
Study First Received:	June 11, 2008
Last Updated:	June 18, 2008
ClinicalTrials.gov Identifier:	NCT00702026
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

Study placed in the following topic categories:

Hypersensitivity
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases

Irritable Bowel Syndrome
Intestinal Diseases
Colonic Diseases, Functional

Additional relevant MeSH terms:

Pathologic Processes
Disease
Immune System Diseases
Syndrome

ClinicalTrials.gov processed this record on January 15, 2009