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Status unknownNCT00368758Updated Aug 25, 2006

The Effect of Probioticson Bloating in IBS

An interventional study of Probiotic bacteria (Trevis R) in Irritable Bowel Syndrome, sponsored by Royal Veterinary and Agricultural University, Denmark. Status unknown at 1 site in Denmark. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2006-08-25.

Sponsored by Royal Veterinary and Agricultural University, Denmark · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2006), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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)

Read the 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.

02

Conditions studied

  • Irritable Bowel Syndrome

Keywords

  • Meteorism
  • Bloating
  • Irritable bowel syndrome (IBS)
  • Probiotics
  • Bowel gas
03

In context

Irritable Bowel Syndrome

1,062 studies on the registry are indexed under Irritable Bowel Syndrome; 190 are open to participants now.

This study's enrollment of 20 is below the median of 71 across 853 interventional studies indexed under Irritable Bowel Syndrome.

Browse Irritable Bowel Syndrome studies →

Lead sponsor

This is the only study on the registry with Royal Veterinary and Agricultural University, Denmark as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double
Enrollment
20 participants

Interventions

  • DrugProbiotic bacteria (Trevis R)
06

What researchers measure

Primary outcomes

  1. In-vitro production (quantified) of hydrogen and methane in feces

  2. Recovery of ingested bacteria in feces by PCR

Secondary outcomes

  1. Quality of life (SF36-danish version)

  2. VAS-scores for bloating, distention, abdominal pain, abdominal discomfort, flatulence

  3. Abdominal height in lying position, waist circumference, weight

07

Study locations

1 of 1 sites recruiting
  • Dept. Human Nutrition, The Royal Veterinary and Agricultural University
    Copenhagen, DK-1958-FC, Denmark
    • Jens R Andersen, MD · Contact · jra@kvl.dk · +45 3528 2504
    • Jens R Andersen, MD · Principal investigator
    Recruiting
08

References and documents

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. doi: 10.1172/JCI115716. PubMed 1556190 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 25, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00368758
Lead sponsor
Royal Veterinary and Agricultural University, Denmark
First posted
Aug 25, 2006
Start date
Aug 2006
Completion
Sep 2007
Last update
Aug 25, 2006

Study contacts

Jens R Andersen, MD
Contact
jra@kvl.dk
+45 3528 2504
Julie Schrøder, student
Contact
juliebs@dsr.kvl.dk
+45 3528 2487
Jens R Andersen, MD
principal investigator · Dept. Human Nutrition, The Royal Veterinary and Agricultural University, Copenhagen
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Aug 2006. You cannot join it, but the record below documents what was studied.

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