Irritable Bowel SyndromeNCT01613456
Effect of Saccharomyces Cerevisiae on the Symptoms of Irritable Bowel Syndrome
A study testing Saccharomyces cerevisiae CNCM I-3856 in people with Irritable Bowel Syndrome, run by Lesaffre International at 1 site in France.
Trial summary
The main purpose of this study is the effect of the probiotic yeast Saccharomyces cerevisiae CNCM I-3856 on abdominal pain or intestinal discomfort in patients presenting with the irritable bowel syndrome (IBS) Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Saccharomyces cerevisiae CNCM I-3856
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 364 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2011to Jun 2013
- 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
- IBS subject meeting the Rome III criteria , with a discomfort or pain present more than 1 day per week in whom organic causes of their symptoms have been excluded
- IBS-C with less than 3 complete spontaneous bowel movements/week
- IBS-D with at least 2 or more days/week one stool which has consistency of type 6 or 7 Bristol stool score
- Subject able of and willing to comply with the protocol and to give their written informed consents
Who cannot join
- History of chronic gastrointestinal disorders
- History of lactose intolerance
- History of gluten intolerance
- Treatment able to influence IBS, modifying intestinal sensitivity and motility (antidepressants,opioid, narcotic analgesics)
- Eating disorders
- Pregnancy in progress
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of S.Cerevisiae vs Placebo on the Improvement of Gastrointestinal Disorders,Especially During Irritable Bowel Syndrome. Randomized, Double-blind Study
The main purpose of this study is the effect of the probiotic yeast Saccharomyces cerevisiae CNCM I-3856 on abdominal pain or intestinal discomfort in patients presenting with the irritable bowel syndrome (IBS)
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Saccharomyces cerevisiae CNCM I-3856, Placebo
- 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.
Saccharomyces cerevisiae CNCM I-3856Dietary supplement
2 capsules/day during 12 weeks
PlaceboDietary supplement
Capsule with comparable organoleptic properties and weight than the experimental product.
2 capsules/day during 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Dicalcium phosphate, Maltodextrin and Magnesium stearate. Receives: Dietary Supplement: Placebo |
| Saccharomyces cerevisiae CNCM I-3856 | Experimental | Not described Receives: Dietary Supplement: Saccharomyces cerevisiae CNCM I-3856 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in discomfort score,obtained by Daily Likert Scale averaged by week
Measured: baseline and week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2012 (estimated)
- Study startDec 2011
- Primary completionJun 2013
- Study completionJun 2013
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 364 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lesaffre International
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioFortis, University of Nottingham
- Responsible party
- Sponsor
- Investigators
- David GENDRE, MD, Principal investigator, BioFortisRobin SPILLER, Professor of Gastroenterology, Principal investigator, Nottingham Digestive Diseases Centre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01613456
- Sponsor's protocol ID
- PEC11010
- Other IDs
- ID RCB: 2011-A00915-36
- Status last verified
- May 2015
- First submitted
- 5 Jun 2012
- Last updated
- 14 May 2015
- Results posted
- No
Publications
Spiller R, Pelerin F, Cayzeele Decherf A, Maudet C, Housez B, Cazaubiel M, Justen P. Randomized double blind placebo-controlled trial of Saccharomyces cerevisiae CNCM I-3856 in irritable bowel syndrome: improvement in abdominal pain and bloating in those with predominant constipation. United European Gastroenterol J. 2016 Jun;4(3):353-62. doi: 10.1177/2050640615602571. Epub 2015 Aug 21.
PubMed 27403301
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of S.Cerevisiae vs Placebo on the Improvement of Gastrointestinal Disorders,Especially During Irritable Bowel Syndrome. Randomized, Double-blind Study
- ClinicalTrials.gov ID
- NCT01613456
- Acronym / sponsor ID
- PEC11010
- Conditions
- Irritable Bowel Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 364 participants (actual)
- Lead sponsor
- Lesaffre InternationalIndustry (pharma, biotech, devices)
- Collaborators
- BioFortis, University of Nottingham
- Study start
- Dec 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 7 Jun 2012 (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 main purpose of this study is the effect of the probiotic yeast Saccharomyces cerevisiae CNCM I-3856 on abdominal pain or intestinal discomfort in patients presenting with the irritable bowel syndrome (IBS)
Study design
- Primary purpose
- Supportive care
- 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: PlaceboDicalcium phosphate, Maltodextrin and Magnesium stearate. |
| Saccharomyces cerevisiae CNCM I-3856 | Experimental | Dietary Supplement: Saccharomyces cerevisiae CNCM I-3856 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- IBS subject meeting the Rome III criteria , with a discomfort or pain present more than 1 day per week in whom organic causes of their symptoms have been excluded
- IBS-C with less than 3 complete spontaneous bowel movements/week
- IBS-D with at least 2 or more days/week one stool which has consistency of type 6 or 7 Bristol stool score
- Subject able of and willing to comply with the protocol and to give their written informed consents
Key exclusion criteria (6 listed)
- History of chronic gastrointestinal disorders
- History of lactose intolerance
- History of gluten intolerance
- Treatment able to influence IBS, modifying intestinal sensitivity and motility (antidepressants,opioid, narcotic analgesics)
- Eating disorders
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 |
|---|---|---|
| Saccharomyces cerevisiae CNCM I-38562 capsules/day during 12 weeks | Dietary supplement | Saccharomyces cerevisiae CNCM I-3856 |
| PlaceboCapsule with comparable organoleptic properties and weight than the experimental product. 2 capsules/day during 12 weeks | Dietary supplement | Placebo |
Primary outcome
Change from baseline in discomfort score,obtained by Daily Likert Scale averaged by week
Time frame: baseline and week 8
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 14 May 2015.
- Derived from this study: PubMed 27403301Spiller R, Pelerin F, Cayzeele Decherf A, Maudet C, Housez B, Cazaubiel M, Justen P. Randomized double blind placebo-controlled trial of Saccharomyces cerevisiae CNCM I-3856 in irritable bowel syndrome: improvement in abdominal pain and bloating in those with predominant constipation. United European Gastroenterol J. 2016 Jun;4(3):353-62. doi: 10.1177/2050640615602571. Epub 2015 Aug 21.
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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.
David GENDRE, MD principal investigator
BioFortis
Robin SPILLER, Professor of Gastroenterology principal investigator
Nottingham Digestive Diseases Centre 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 Saccharomyces cerevisiae CNCM I-3856 in people with Irritable Bowel Syndrome, run by Lesaffre International 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 4 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: finished, as of the sponsor's last update on 14 May 2015. 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.
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?
Change from baseline in discomfort score,obtained by Daily Likert Scale averaged by week (time frame: baseline and week 8). 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 NCT01613456, 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 14 May 2015.