Irritable Bowel SyndromeNCT01151657
Probiotics for Irritable Bowel Syndrome
A study testing Probiotics in people with Irritable Bowel Syndrome, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
The study aims to investigate the effect of probiotics on IBS-patients symptoms compared to placebo, when given for 6 months. By draw the investigators give IBS patients, in the age of 18-50 years, capsules with either probiotics or placebo. The patients are to take 2x2 capsules / day for 6 months. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Probiotics
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2009to Jun 2011
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Fulfill ROME III criteria
- age 18-50 years
- signed informed content
Who cannot join
- Danger signals (fever, anaemia, weightloss, blod in stools, predisposition for CRC or IBD)
- abnormal physical examination
- comorbidity
- abuse
- lacking ability to talk and understand danish
- pregnancy
- For patients > 40 years. Changed bowel habits, with duration > 3 weeks, but < 1 year
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Research Unit for General Practice, Department of gastroenterology, Odense University hospital
Odense, Odense, 5000
About this study
The study aims to investigate the effect of probiotics on IBS-patients symptoms compared to placebo, when given for 6 months.
By draw the investigators give IBS patients, in the age of 18-50 years, capsules with either probiotics or placebo. The patients are to take 2x2 capsules / day for 6 months. The patients are followed for 1 year. They are seen after 3, 6 and 12 months, and are followed by means of monthly letters.
Read more
The capsules contain 3 different probiotic strains - Lactobacillus paracasei ssp paracasei F19, Lactobacillus acidophilus La5 and Bifidobacterium Bb12. The dose is 2 x 109 - 10 x 109 CFU/capsule.
The hypothesis is, that there is a clinical difference between the group receiving probiotics and the group receiving placebo.
Read the detailed description
Background: In management of IBS, no treatments have showed great efficacy. IBS is a non-fatal disease, so safety is a high priority in the choice of treatment. Probiotics is a dietary supplement and have no adverse effects. In some studies it has shown beneficial effect on some of the IBS patients symptoms, but some of the results are questionable. The studies have to be of longer duration, with more patients and the probiotics have to be capsules instead of milk based drinks.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Probiotics, Placebo
- Keywords
- IBS, Irritable bowel syndrome, Probiotics, Treatment, Adequate relief
- 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.
ProbioticsDietary supplement
Capsules with probiotics containing the strains : Lactobacillus paracasei ssp paracasei F19, Lactobacillus acidophilus La5 og Bifidobacterium Bb12. Dose/capsule : 2 x 109 - 10 x 109 CFU.
PlaceboDietary supplement
Placebo capsules containing maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Capsules containing maltodextrin. Receives: Dietary Supplement: Placebo |
| Probiotics | Experimental | Probiotics containing the 3 strains: Lactobacillus paracasei ssp paracasei F19, Lactobacillus acidophilus La5 og Bifidobacterium Bb12 in the dose of 2 x 109 - 10 x 109 CFU/capsule. The patients are to take 2x2 capsules a day. Receives: Dietary Supplement: Probiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adequate relief
The patients are asked "In the last seven days, have you had adequate relief of your IBS symptoms?" . They are asked this question every month ( in a monthly letter) for 12 months.
Measured: Every month for 12 months
Secondary outcomes (1)
gastrointestinal symptoms
We use the questionnaires GSRS-IBS and GSRS. The patients are asked every month (in monthly letters) for 12 months.
Measured: Every month for 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2010 (estimated)
- Study startJan 2009
- Primary completionJun 2011
- Study completionJun 2011
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.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Mejeribrugets ForskningsFond, Arla Foods
- Responsible party
- Principal investigator, Luise Molenberg Begtrup, University of Southern Denmark
- Investigators
- Ove B Schaffalitzky de Muckadell, Dr.Med, Professor, Principal investigator, Department of gastroenterology, Odense University hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01151657
- Sponsor's protocol ID
- MFF080409-2
- Status last verified
- Jan 2009
- First submitted
- 25 Jun 2010
- Last updated
- 25 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Begtrup LM, de Muckadell OB, Kjeldsen J, Christensen RD, Jarbol DE. Long-term treatment with probiotics in primary care patients with irritable bowel syndrome--a randomised, double-blind, placebo controlled trial. Scand J Gastroenterol. 2013 Oct;48(10):1127-35. doi: 10.3109/00365521.2013.825314. Epub 2013 Aug 19.
PubMed 23957590
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotics for Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT01151657
- Acronym / sponsor ID
- MFF080409-2
- Conditions
- Irritable Bowel Syndrome
- Keywords
- IBS, Irritable bowel syndrome, Probiotics, Treatment, Adequate relief
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Mejeribrugets ForskningsFond, Arla Foods
- Study start
- Jan 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 28 Jun 2010 (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 study aims to investigate the effect of probiotics on IBS-patients symptoms compared to placebo, when given for 6 months.
By draw the investigators give IBS patients, in the age of 18-50 years, capsules with either probiotics or placebo. The patients are to take 2x2 capsules / day for 6 months. The patients are followed for 1 year. They are seen after 3, 6 and 12 months, and are followed by means of monthly letters.
The capsules contain 3 different probiotic strains - Lactobacillus paracasei ssp paracasei F19, Lactobacillus acidophilus La5 and Bifidobacterium Bb12. The dose is 2 x 109 - 10 x 109 CFU/capsule.
The hypothesis is, that there is a clinical difference between the group receiving probiotics and the group receiving placebo.
Detailed description
Background: In management of IBS, no treatments have showed great efficacy. IBS is a non-fatal disease, so safety is a high priority in the choice of treatment. Probiotics is a dietary supplement and have no adverse effects. In some studies it has shown beneficial effect on some of the IBS patients symptoms, but some of the results are questionable. The studies have to be of longer duration, with more patients and the probiotics have to be capsules instead of milk based drinks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboCapsules containing maltodextrin. |
| Probiotics | Experimental | Dietary Supplement: ProbioticsProbiotics containing the 3 strains: Lactobacillus paracasei ssp paracasei F19, Lactobacillus acidophilus La5 og Bifidobacterium Bb12 in the dose of 2 x 109 - 10 x 109 CFU/capsule. The patients are to take 2x2 capsules a day. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Fulfill ROME III criteria
- age 18-50 years
- signed informed content
Key exclusion criteria (7 listed)
- Danger signals (fever, anaemia, weightloss, blod in stools, predisposition for CRC or IBD)
- abnormal physical examination
- comorbidity
- abuse
- lacking ability to talk and understand 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 |
|---|---|---|
| ProbioticsCapsules with probiotics containing the strains : Lactobacillus paracasei ssp paracasei F19, Lactobacillus acidophilus La5 og Bifidobacterium Bb12. Dose/capsule : 2 x 109 - 10 x 109 CFU. | Dietary supplement | Probiotics |
| PlaceboPlacebo capsules containing maltodextrin | Dietary supplement | Placebo |
Primary outcome
Adequate relief
Time frame: Every month for 12 months
The patients are asked "In the last seven days, have you had adequate relief of your IBS symptoms?" . They are asked this question every month ( in a monthly letter) for 12 months.
1 secondary outcome
gastrointestinal symptoms
Time frame: Every month for 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2011.
- Derived from this study: PubMed 23957590Begtrup LM, de Muckadell OB, Kjeldsen J, Christensen RD, Jarbol DE. Long-term treatment with probiotics in primary care patients with irritable bowel syndrome--a randomised, double-blind, placebo controlled trial. Scand J Gastroenterol. 2013 Oct;48(10):1127-35. doi: 10.3109/00365521.2013.825314. Epub 2013 Aug 19.
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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.
Ove B Schaffalitzky de Muckadell, Dr.Med, Professor principal investigator
Department of gastroenterology, Odense University hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotics in people with Irritable Bowel Syndrome, run by University of Southern 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 3 inclusion and 7 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: finished, as of the sponsor's last update on 25 Oct 2011. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adequate relief (time frame: Every month for 12 months). 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 NCT01151657, 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 Oct 2011; AzTrials last refreshed its copy on 2 Nov 2026.