The Effect of Probioticson Bloating in IBS

This study is currently recruiting participants.

Verified by Royal Veterinary and Agricultural University, Denmark, August 2006

First Received: August 24, 2006 No Changes Posted

Sponsored by:	Royal Veterinary and Agricultural University, Denmark
Information provided by:	Royal Veterinary and Agricultural University, Denmark
ClinicalTrials.gov Identifier:	NCT00368758

Purpose

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)

Condition	Intervention
Irritable Bowel Syndrome	Drug: Probiotic bacteria (Trevis R)

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	The Effect of Probioticson Bloating in IBS

Resource links provided by NLM:

MedlinePlus related topics: Gas

U.S. FDA Resources

Further study details as provided by Royal Veterinary and Agricultural University, Denmark:

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

Estimated Enrollment:	20
Study Start Date:	August 2006
Estimated Study Completion Date:	September 2007

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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.)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00368758

Contacts

Contact: Jens R Andersen, MD	+45 3528 2504	jra@kvl.dk
Contact: Julie Schrøder, student	+45 3528 2487	juliebs@dsr.kvl.dk

Locations

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

Sponsors and Collaborators

Royal Veterinary and Agricultural University, Denmark

Investigators

Principal Investigator:

Jens R Andersen, MD

Dept. Human Nutrition, The Royal Veterinary and Agricultural University, Copenhagen

More Information

Publications:

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.

Study ID Numbers:	JRA1
Study First Received:	August 24, 2006
Last Updated:	August 24, 2006
ClinicalTrials.gov Identifier:	NCT00368758 History of Changes
Health Authority:	Denmark: Danish Medicines Agency

Keywords provided by Royal Veterinary and Agricultural University, Denmark:

Meteorism
Bloating
Irritable bowel syndrome (IBS)
Probiotics
Bowel gas

Study placed in the following topic categories:

Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Irritable Bowel Syndrome

Flatulence
Intestinal Diseases
Colonic Diseases, Functional

Additional relevant MeSH terms:

Pathologic Processes
Disease
Digestive System Diseases
Gastrointestinal Diseases
Syndrome

Colonic Diseases
Irritable Bowel Syndrome
Intestinal Diseases
Colonic Diseases, Functional

ClinicalTrials.gov processed this record on August 12, 2009