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The Effect of Probioticson Bloating in IBS

NCT ID: NCT00368758

Last Updated: 2006-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2007-09-30

Brief Summary

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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

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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.

Conditions

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Irritable Bowel Syndrome

Keywords

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Meteorism Bloating Irritable bowel syndrome (IBS) Probiotics Bowel gas

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Probiotic bacteria (Trevis R)

Intervention Type DRUG

Eligibility Criteria

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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.)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Royal Veterinary and Agricultural University, Denmark

OTHER

Sponsor Role lead

Principal Investigators

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Jens R Andersen, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Dept. Human Nutrition, The Royal Veterinary and Agricultural University

Copenhagen, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Jens R Andersen, MD

Role: CONTACT

Phone: +45 3528 2504

Email: [email protected]

Julie Schrøder, student

Role: CONTACT

Phone: +45 3528 2487

Email: [email protected]

Facility Contacts

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Jens R Andersen, MD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 1556190 (View on PubMed)

Other Identifiers

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JRA1

Identifier Type: -

Identifier Source: org_study_id