Functional Gastrointestinal DisordersNCT00355810
Probiotics for Irritable Bowel Syndrome
A study of Functional Gastrointestinal Disorders and Irritable Bowel Syndrome, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
This randomised, double blind, cross-over study compares the effect (symptoms, fecal bacterial growth, gas production) of three weeks' treatment with lactobacillus plantarum MF 1298 with placebo in patients with irritable bowel syndrome. The results are related to dietary habits, food intolerance and food allergy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Functional Gastrointestinal Disorders, Irritable Bowel Syndrome
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2006to Dec 2006
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Irritable bowel syndrome according to the Rome II criteria
- regular symptoms
Who cannot join
- Use of probiotics last three weeks
- pregnancy
- lactation
- co-existing other gastrointestinal disorders
- use of laxatives and antibiotics within last 5 weeks.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lactobacillus Plantarum MF 1298 vs Placebo for Irritable Bowel Syndrome.
This randomised, double blind, cross-over study compares the effect (symptoms, fecal bacterial growth, gas production) of three weeks' treatment with lactobacillus plantarum MF 1298 with placebo in patients with irritable bowel syndrome. The results are related to dietary habits, food intolerance and food allergy.
- Being tested
- placebo followed by Lactobacillus plantarum MF 1298, Lactobacillus plantarum MF1298 followed by placebo
- Keywords
- Probiotics
- Medical subject headings
- Gastrointestinal Diseases, Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placebo followed by Lactobacillus plantarum MF 1298Dietary supplement
Also called probiotic
placebo during 3 weeks, washout period 4 weeks, Lactobacillus plantarum MF1298 during 3 weeks
Lactobacillus plantarum MF1298 followed by placeboDietary supplement
Also called probiotic
Lactobacillus plantarum MF1298 during 3 weeks, washout period 4 weeks, placebo during 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| placebo followed by probiotic | Experimental | placebo, then washout period, then Lactobacillus plantarum MF1298 Receives: Dietary Supplement: placebo followed by Lactobacillus plantarum MF 1298 |
| probiotic followed by placebo | Experimental | Lactobacillus plantarum MF1298, then washout period, then placebo Receives: Dietary Supplement: Lactobacillus plantarum MF1298 followed by placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfactory relief of abdominal symptoms
relief of symptoms recorded on diary cards
Measured: 11 weeks
Secondary outcomes (4)
Graded measurement of abdominal symptoms
IBS sum score
Measured: 11 weeks
Fecal bacterial count
Measured: 11 weeks
Abdominal gas
Measured: 11 weeks
Immunological parameters
Measured: 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2006 (estimated)
- Study startJan 2006
- Primary completionApr 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Functional Gastrointestinal DisordersStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Food Research, Gilde, Norwegian Foundation for Health and Rehabilitation, Sykehuset Innlandet HF
- Responsible party
- Sponsor
- Investigators
- Per G Farup, PhD, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00355810
- Sponsor's protocol ID
- REK 4.2005.2284
- Status last verified
- Jul 2016
- First submitted
- 24 Jul 2006
- Last updated
- 19 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Ligaarden SC, Axelsson L, Naterstad K, Lydersen S, Farup PG. A candidate probiotic with unfavourable effects in subjects with irritable bowel syndrome: a randomised controlled trial. BMC Gastroenterol. 2010 Feb 10;10:16. doi: 10.1186/1471-230X-10-16.
PubMed 20144246Farup PG, Jacobsen M, Ligaarden SC, Rudi K. Probiotics, symptoms, and gut microbiota: what are the relations? A randomized controlled trial in subjects with irritable bowel syndrome. Gastroenterol Res Pract. 2012;2012:214102. doi: 10.1155/2012/214102. Epub 2012 Jul 31.
PubMed 22899904
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lactobacillus Plantarum MF 1298 vs Placebo for Irritable Bowel Syndrome.
- ClinicalTrials.gov ID
- NCT00355810
- Acronym / sponsor ID
- REK 4.2005.2284
- Keywords
- Probiotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Norwegian Food Research, Gilde, Norwegian Foundation for Health and Rehabilitation, Sykehuset Innlandet HF
- Study start
- Jan 2006
- Primary completion
- Apr 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 25 Jul 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.
This randomised, double blind, cross-over study compares the effect (symptoms, fecal bacterial growth, gas production) of three weeks' treatment with lactobacillus plantarum MF 1298 with placebo in patients with irritable bowel syndrome. The results are related to dietary habits, food intolerance and food allergy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo followed by probiotic | Experimental | Dietary Supplement: placebo followed by Lactobacillus plantarum MF 1298placebo, then washout period, then Lactobacillus plantarum MF1298 |
| probiotic followed by placebo | Experimental | Dietary Supplement: Lactobacillus plantarum MF1298 followed by placeboLactobacillus plantarum MF1298, then washout period, then placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Irritable bowel syndrome according to the Rome II criteria
- regular symptoms
Key exclusion criteria (5 listed)
- Use of probiotics last three weeks
- pregnancy
- lactation
- co-existing other gastrointestinal disorders
- use of laxatives and antibiotics within last 5 weeks.
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 |
|---|---|---|
| placebo followed by Lactobacillus plantarum MF 1298Also: probioticplacebo during 3 weeks, washout period 4 weeks, Lactobacillus plantarum MF1298 during 3 weeks | Dietary supplement | placebo followed by probiotic |
| Lactobacillus plantarum MF1298 followed by placeboAlso: probioticLactobacillus plantarum MF1298 during 3 weeks, washout period 4 weeks, placebo during 3 weeks | Dietary supplement | probiotic followed by placebo |
Primary outcome
Satisfactory relief of abdominal symptoms
Time frame: 11 weeks
relief of symptoms recorded on diary cards
4 secondary outcomes
Graded measurement of abdominal symptoms
Time frame: 11 weeks
Fecal bacterial count
Time frame: 11 weeks
Abdominal gas
Time frame: 11 weeks
Immunological parameters
Time frame: 11 weeks
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 19 Jul 2016.
- Results publication: PubMed 20144246Ligaarden SC, Axelsson L, Naterstad K, Lydersen S, Farup PG. A candidate probiotic with unfavourable effects in subjects with irritable bowel syndrome: a randomised controlled trial. BMC Gastroenterol. 2010 Feb 10;10:16. doi: 10.1186/1471-230X-10-16.
- Results publication: PubMed 22899904Farup PG, Jacobsen M, Ligaarden SC, Rudi K. Probiotics, symptoms, and gut microbiota: what are the relations? A randomized controlled trial in subjects with irritable bowel syndrome. Gastroenterol Res Pract. 2012;2012:214102. doi: 10.1155/2012/214102. Epub 2012 Jul 31.
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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.
Per G Farup, PhD principal investigator
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Functional Gastrointestinal Disorders and Irritable Bowel Syndrome, run by Norwegian University of Science and Technology at 1 site in Norway.
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 2 inclusion and 5 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 19 Jul 2016. 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 Norway. 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?
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?
Satisfactory relief of abdominal symptoms (time frame: 11 weeks). 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 NCT00355810, which also lists 2 linked publications.
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 19 Jul 2016; AzTrials last refreshed its copy on 31 Oct 2026.