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The Effect of Probioticson Bloating in IBS

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2006 by Royal Veterinary and Agricultural University, Denmark.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00368758
First Posted: August 25, 2006
Last Update Posted: August 25, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Royal Veterinary and Agricultural University, Denmark
  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: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: The Effect of Probioticson Bloating in IBS

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
ClinicalTrials.gov Identifier: NCT00368758     History of Changes
Other Study ID Numbers: JRA1
First Submitted: August 24, 2006
First Posted: August 25, 2006
Last Update Posted: August 25, 2006
Last Verified: August 2006

Keywords provided by Royal Veterinary and Agricultural University, Denmark:
Meteorism
Bloating
Irritable bowel syndrome (IBS)
Probiotics
Bowel gas

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases