The Effect of Probioticson Bloating in IBS

Irritable Bowel Syndrome Clinical Trial

Official title:

The Effect of Probioticson Bloating in IBS

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00368758
• Other study ID #: JRA1
• Status: Recruiting
• Phase: N/A
• First received: August 24, 2006
• Last updated: August 24, 2006
• Start date: August 2006
• Est. completion date: September 2007

Study information

• Verified date: August 2006
• Source: Royal Veterinary and Agricultural University, Denmark
• Contact: Jens R Andersen, MD
• Phone: +45 3528 2504
• Email: jra[@]kvl.dk
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Irritable Bowel Syndrome

Intervention

Drug:
• Probiotic bacteria (Trevis R)

Locations

Country	Name	City	State
Denmark	Dept. Human Nutrition, The Royal Veterinary and Agricultural University	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Royal Veterinary and Agricultural University, Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-vitro production (quantified) of hydrogen and methane in feces
Primary	Recovery of ingested bacteria in feces by PCR
Secondary	Quality of life (SF36-danish version)
Secondary	VAS-scores for bloating, distention, abdominal pain, abdominal discomfort, flatulence
Secondary	Abdominal height in lying position, waist circumference, weight