Irritable Bowel SyndromePhase 2NCT00561535
Effect of a Probiotic, Lactobacillus FARCIMINIS, in Diarrhea Predominant IBS Patients
A Phase 2 study testing Lactobacillus FARCIMINIS in people with Irritable Bowel Syndrome, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Probiotics may improve symptoms in IBS patients. The aim of this study is to test the efficacy of Lactobacillus FARCIMINIS in diarrhea predominant IBS patients according to Rome III criteria. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Lactobacillus FARCIMINIS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2007to Jun 2010
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diarrhea predominant IBS
- Less than 5-year duration
- Pain intensity between 2 and 7 on VAS
Who cannot join
- Celiac disease
- Antibiotic treatment within the 1-month period preceding inclusion
- Digestive organic disease
- Any severe non digestive organic disease
Trial locations and contacts
1 site in 1 country.
France1 site
Hopital Louis Mourier, GI Unit
Colombes, Île-de-France Region, 92700
About this study
Official title: Effect of a Probiotic, Lactobacillus FARCIMINIS, in Diarrhea Predominant IBS
Probiotics may improve symptoms in IBS patients. The aim of this study is to test the efficacy of Lactobacillus FARCIMINIS in diarrhea predominant IBS patients according to Rome III criteria.
Read the detailed description
The aim of this study is to test the efficacy of Lactobacillus FARCIMINIS in diarrhea predominant IBS patients according to Rome III criteria.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Lactobacillus FARCIMINIS, placebo (starch)
- Keywords
- IBS, Diarrhea, Rome III
- Medical subject headings
- Irritable Bowel Syndrome, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus FARCIMINISDietary supplement
Also called 10.10 UFC of lactobacillus FARCIMINIS
10.10 UFC of lactobacillus FARCIMINIS
placebo (starch)Dietary supplement
Also called Once daily
Once daily
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Lactobacillus FARCIMINIS Receives: Dietary Supplement: Lactobacillus FARCIMINIS |
| B | Placebo comparator | Placebo Receives: Dietary Supplement: placebo (starch) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall subject's assessment
Measured: 4 weeks
Secondary outcomes (1)
Decrease in abdominal pain, stool form and consistency, modifications in intestinal permeability, modification in fecal serine protease activity, modifications in interleukin seric concentrations
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2007 (estimated)
- Study startOct 2007
- Primary completionMay 2010
- Study completionJun 2010
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 Assistance Publique - Hôpitaux de ParisThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Association pour l'Etude des Fonctions Digestives
- Investigators
- Benoit Coffin, Prof, Principal investigator, Assistance Publique - Hôpitaux de ParisYoram Bouhnik, Prof, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00561535
- Sponsor's protocol ID
- AEFD 2007-01
- Status last verified
- Jan 2011
- First submitted
- 20 Nov 2007
- Last updated
- 27 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Camilleri M, Chang L. Challenges to the therapeutic pipeline for irritable bowel syndrome: end points and regulatory hurdles. Gastroenterology. 2008 Dec;135(6):1877-91. doi: 10.1053/j.gastro.2008.09.005. Epub 2008 Oct 9.
PubMed 18848833
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Probiotic, Lactobacillus FARCIMINIS, in Diarrhea Predominant IBS
- ClinicalTrials.gov ID
- NCT00561535
- Acronym / sponsor ID
- AEFD 2007-01
- Conditions
- Irritable Bowel Syndrome
- Keywords
- IBS, Diarrhea, Rome III
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Association pour l'Etude des Fonctions Digestives
- Study start
- Oct 2007
- Primary completion
- May 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 21 Nov 2007 (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.
Probiotics may improve symptoms in IBS patients. The aim of this study is to test the efficacy of Lactobacillus FARCIMINIS in diarrhea predominant IBS patients according to Rome III criteria.
Detailed description
The aim of this study is to test the efficacy of Lactobacillus FARCIMINIS in diarrhea predominant IBS patients according to Rome III criteria.
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 |
|---|---|---|
| A | Experimental | Dietary Supplement: Lactobacillus FARCIMINISLactobacillus FARCIMINIS |
| B | Placebo comparator | Dietary Supplement: placebo (starch)Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diarrhea predominant IBS
- Less than 5-year duration
- Pain intensity between 2 and 7 on VAS
Key exclusion criteria (4 listed)
- Celiac disease
- Antibiotic treatment within the 1-month period preceding inclusion
- Digestive organic disease
- Any severe non digestive organic disease
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 |
|---|---|---|
| Lactobacillus FARCIMINISAlso: 10.10 UFC of lactobacillus FARCIMINIS10.10 UFC of lactobacillus FARCIMINIS | Dietary supplement | A |
| placebo (starch)Also: Once dailyOnce daily | Dietary supplement | B |
Primary outcome
Overall subject's assessment
Time frame: 4 weeks
1 secondary outcome
Decrease in abdominal pain, stool form and consistency, modifications in intestinal permeability, modification in fecal serine protease activity, modifications in interleukin seric concentrations
Time frame: 4 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 27 Jan 2011.
- Background: PubMed 18848833Camilleri M, Chang L. Challenges to the therapeutic pipeline for irritable bowel syndrome: end points and regulatory hurdles. Gastroenterology. 2008 Dec;135(6):1877-91. doi: 10.1053/j.gastro.2008.09.005. Epub 2008 Oct 9.
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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.
Benoit Coffin, Prof principal investigator
Assistance Publique - Hôpitaux de Paris
Yoram Bouhnik, Prof study director
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lactobacillus FARCIMINIS in people with Irritable Bowel Syndrome, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 4 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 27 Jan 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 France. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Overall subject's assessment (time frame: 4 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 NCT00561535, 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 27 Jan 2011.