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Sponsors and Collaborators: |
Maastricht University Medical Center Winclove Bio Industries BV |
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Information provided by: | Maastricht University Medical Center |
ClinicalTrials.gov Identifier: | NCT00702026 |
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 |
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Irritable Bowel Syndrome Hypersensitivity |
Dietary Supplement: multispecies probiotic (Ecologic 801) Dietary Supplement: Placebo |
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 |
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 |
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1: Experimental |
Dietary Supplement: multispecies probiotic (Ecologic 801)
once daily, 5 gram [10e9 cfu/gram]
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2: Placebo Comparator |
Dietary Supplement: Placebo
once daily, 5 gram [10e9 cfu/gram]
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Catherina JM Koning, MSC | 31-43-388-1982 |
Netherlands | |
University Hospital Maastricht | |
Maastricht, Netherlands |
Principal Investigator: | A AM Masclee, Prof. Dr. | Maastricht University Medical Center |
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 History of Changes |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Irritable Bowel Syndrome Hypersensitivity Probiotics Multispecies |
Hypersensitivity Digestive System Diseases Gastrointestinal Diseases Colonic Diseases |
Irritable Bowel Syndrome Intestinal Diseases Colonic Diseases, Functional |
Hypersensitivity Pathologic Processes Disease Digestive System Diseases Immune System Diseases Gastrointestinal Diseases |
Syndrome Colonic Diseases Irritable Bowel Syndrome Intestinal Diseases Colonic Diseases, Functional |