Irritable Bowel SyndromeNCT00368758
The Effect of Probioticson Bloating in IBS
A study testing Probiotic bacteria (Trevis R) in people with Irritable Bowel Syndrome, run by Royal Veterinary and Agricultural University, Denmark at 1 site in Denmark.
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) Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Probiotic bacteria (Trevis R)
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2006to Sep 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Dept. Human Nutrition, The Royal Veterinary and Agricultural University
Copenhagen, DK-1958-FC
Jens R Andersen, MD, +45 3528 2504, jra@kvl.dk
Jens R Andersen, MD
About this study
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.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Probiotic bacteria (Trevis R)
- Keywords
- Meteorism, Bloating, Irritable bowel syndrome (IBS), Probiotics, Bowel gas
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic bacteria (Trevis R)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
In-vitro production (quantified) of hydrogen and methane in feces
Recovery of ingested bacteria in feces by PCR
Secondary outcomes (3)
Quality of life (SF36-danish version)
VAS-scores for bloating, distention, abdominal pain, abdominal discomfort, flatulence
Abdominal height in lying position, waist circumference, weight
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2006 (estimated)
- Study startAug 2006
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Royal Veterinary and Agricultural University, Denmark
- Sponsor type
- University, hospital or other
- Investigators
- Jens R Andersen, MD, Principal investigator, Dept. Human Nutrition, The Royal Veterinary and Agricultural University, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00368758
- Sponsor's protocol ID
- JRA1
- Status last verified
- Aug 2006
- First submitted
- 24 Aug 2006
- Last updated
- 25 Aug 2006
- Results posted
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Probioticson Bloating in IBS
- ClinicalTrials.gov ID
- NCT00368758
- Acronym / sponsor ID
- JRA1
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Meteorism, Bloating, Irritable bowel syndrome (IBS), Probiotics, Bowel gas
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants
- Lead sponsor
- Royal Veterinary and Agricultural University, DenmarkUniversity, hospital or other
- Study start
- Aug 2006
- Study completion
- Sep 2007
- First posted
- 25 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic bacteria (Trevis R) | Drug | – |
Primary outcome
In-vitro production (quantified) of hydrogen and methane in feces
Recovery of ingested bacteria in feces by PCR
3 secondary outcomes
Quality of life (SF36-danish version)
VAS-scores for bloating, distention, abdominal pain, abdominal discomfort, flatulence
Abdominal height in lying position, waist circumference, weight
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2006.
- Background: PubMed 1556190Strocchi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens R Andersen, MD principal investigator
Dept. Human Nutrition, The Royal Veterinary and Agricultural University, Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic bacteria (Trevis R) in people with Irritable Bowel Syndrome, run by Royal Veterinary and Agricultural University, Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Aug 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jens R Andersen, MD (+45 3528 2504, jra@kvl.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-vitro production (quantified) of hydrogen and methane in feces. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00368758, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2006.