Status:
COMPLETED
The Effect of a Multispecies Probiotic on Hypersensitivity in Irritable Bowel Syndrome (IBS) Patients
Lead Sponsor:
Maastricht University Medical Center
Collaborating Sponsors:
Winclove Bio Industries BV
Conditions:
Irritable Bowel Syndrome
Hypersensitivity
Eligibility:
All Genders
18-65 years
Phase:
NA
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). ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00702026
Start Date
August 1 2008
End Date
December 1 2011
Last Update
January 29 2013
Active Locations (1)
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1
University Hospital Maastricht
Maastricht, Netherlands