The Effect of Probioticson Bloating in IBS

August 24, 2006 updated by: Royal Veterinary and Agricultural University, Denmark
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)

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, DK-1958-FC
        • Recruiting
        • Dept. Human Nutrition, The Royal Veterinary and Agricultural University
        • Contact:
          • Jens R Andersen, MD
          • Phone Number: +45 3528 2504
          • Email: jra@kvl.dk
        • Principal Investigator:
          • Jens R Andersen, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Veterinary and Agricultural University, Denmark

Investigators

  • Principal Investigator: Jens R Andersen, MD, Dept. Human Nutrition, The Royal Veterinary and Agricultural University, Copenhagen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Study Completion

September 1, 2007

Study Registration Dates

First Submitted

August 24, 2006

First Submitted That Met QC Criteria

August 24, 2006

First Posted (Estimate)

August 25, 2006

Study Record Updates

Last Update Posted (Estimate)

August 25, 2006

Last Update Submitted That Met QC Criteria

August 24, 2006

Last Verified

August 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JRA1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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