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The Effect of Probioticson Bloating in IBS

Primary Purpose

Irritable Bowel Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Probiotic bacteria (Trevis R)
Sponsored by
Royal Veterinary and Agricultural University, Denmark
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Meteorism, Bloating, Irritable bowel syndrome (IBS), Probiotics, Bowel gas

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: - Female test persons with symptoms of meteorism, the age of > 18 years, completely integrated in the Danish society (including nutrition), and no previous abdominal surgery besides from appendicectomy (advertisement in a local newspaper for test persons). Exclusion Criteria: Lactose and sorbitol intolerant persons (based on hydrogen breath tests). Persons with chronic ingestion of medicine, that might have an effect on gut bacterial flora or bowel motility. Persons taking antibiotics within 2 month prior to the trial Persons with diagnosed gastrointestinal disease other than IBS. Persons not able to understand and/or read Danish. Persons under age and persons with obvious problems remembering and sticking to the protocol (persons with dementia, psychological illness etc.)

Sites / Locations

  • Dept. Human Nutrition, The Royal Veterinary and Agricultural UniversityRecruiting

Outcomes

Primary Outcome Measures

In-vitro production (quantified) of hydrogen and methane in feces
Recovery of ingested bacteria in feces by PCR

Secondary Outcome Measures

Quality of life (SF36-danish version)
VAS-scores for bloating, distention, abdominal pain, abdominal discomfort, flatulence
Abdominal height in lying position, waist circumference, weight

Full Information

First Posted
August 24, 2006
Last Updated
August 24, 2006
Sponsor
Royal Veterinary and Agricultural University, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT00368758
Brief Title
The Effect of Probioticson Bloating in IBS
Official Title
The Effect of Probioticson Bloating in IBS
Study Type
Interventional

2. Study Status

Record Verification Date
August 2006
Overall Recruitment Status
Unknown status
Study Start Date
August 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Royal Veterinary and Agricultural University, Denmark

4. Oversight

5. Study Description

Brief Summary
The purpose of the study is to establish an in-vitro method to evaluate the effect of probiotics on gas production in feces (hydrogen and methane)
Detailed Description
The objective of this study is to establish a model for screening probiotic bacteria in the treatment of meteorism symptoms (feeling of air in the stomach) with otherwise healthy adult women. As excessive bacterial gas production in the intestine is the most likely mechanism behind meteorism, we will examine eventual changes of the production of gases (hydrogen and methane) before and after administration of Trevis®. For screening of Trevis® we will apply a combination of clinical examination and a laboratory model for the determination of gastrointestinal gas production (a new method in connection with studies on probiotics). The results will be compared with the test person's specification of their health, both with respect to gastrointestinal function and in general through questionnaires. The background for the project will be described in the following.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
Meteorism, Bloating, Irritable bowel syndrome (IBS), Probiotics, Bowel gas

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
20 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Probiotic bacteria (Trevis R)
Primary Outcome Measure Information:
Title
In-vitro production (quantified) of hydrogen and methane in feces
Title
Recovery of ingested bacteria in feces by PCR
Secondary Outcome Measure Information:
Title
Quality of life (SF36-danish version)
Title
VAS-scores for bloating, distention, abdominal pain, abdominal discomfort, flatulence
Title
Abdominal height in lying position, waist circumference, weight

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Female test persons with symptoms of meteorism, the age of > 18 years, completely integrated in the Danish society (including nutrition), and no previous abdominal surgery besides from appendicectomy (advertisement in a local newspaper for test persons). Exclusion Criteria: Lactose and sorbitol intolerant persons (based on hydrogen breath tests). Persons with chronic ingestion of medicine, that might have an effect on gut bacterial flora or bowel motility. Persons taking antibiotics within 2 month prior to the trial Persons with diagnosed gastrointestinal disease other than IBS. Persons not able to understand and/or read Danish. Persons under age and persons with obvious problems remembering and sticking to the protocol (persons with dementia, psychological illness etc.)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jens R Andersen, MD
Phone
+45 3528 2504
Email
jra@kvl.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Julie Schrøder, student
Phone
+45 3528 2487
Email
juliebs@dsr.kvl.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens R Andersen, MD
Organizational Affiliation
Dept. Human Nutrition, The Royal Veterinary and Agricultural University, Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. Human Nutrition, The Royal Veterinary and Agricultural University
City
Copenhagen
ZIP/Postal Code
DK-1958-FC
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jens R Andersen, MD
Phone
+45 3528 2504
Email
jra@kvl.dk
First Name & Middle Initial & Last Name & Degree
Jens R Andersen, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
1556190
Citation
Strocchi A, Levitt MD. Factors affecting hydrogen production and consumption by human fecal flora. The critical roles of hydrogen tension and methanogenesis. J Clin Invest. 1992 Apr;89(4):1304-11. doi: 10.1172/JCI115716.
Results Reference
background

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The Effect of Probioticson Bloating in IBS

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