Irritable Bowel SyndromeNCT00977587
Saccharomyces Cerevisiae CNCM I-3856 Treatment in Irritable Bowel Syndrome With Diarrhea (IBS-D) and Post Infective Bowel Dysfunction
A study testing Saccharomyces Cerevisiae CNCM I-3856 in people with Irritable Bowel Syndrome and Post Infective Bowel Dysfunction, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
Irritable Bowel Syndrome (IBS) is a common condition characterised by abdominal pain or discomfort and altered bowel habit affecting up to 10% of the population. There are several groups of patients that are based on differing bowel patterns including IBS with diarrhea (IBS-D) and those with post infective IBS… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome, Post Infective Bowel Dysfunction
- 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
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2011to Jul 2012
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Study 1 and 2:
- Male or female aged 18-75 years
- Subjects who are able to give informed consent
- Study 1:
- IBS-D patients meeting Rome III Criteria
- Study 2:
- Subjects with stool cultures positive for Campylobacter jejuni
- Healthy volunteer controls
Who cannot join
- Subjects that, in the opinion of the investigator, are considered unsuitable.
- Subjects who have had abdominal surgery which may cause bowel symptoms similar to IBS (Please note, appendicectomy and cholecystectomy is not an exclusion).
- Subjects with a known intolerance to yeast.
- Subjects taking immunosuppressant medication, e.g. long term steroids, or who might otherwise be immunocompromised.
- Subjects who have had a recent course of antibiotics (in the last 28 days).
- Subjects unable to stop anti-diarrhoeal drugs.
Show all 9Show fewer
- Subjects currently participating in another clinical trial or who have been in a trial in the previous three months.
- Patients with known gastrointestinal diseases including coeliac disease and inflammatory bowel disease.
- Regular consumption of drugs known to alter bowel habit (see concomitant medication).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Nottingham University Hospital
Nottingham, Nottinghamshire, NG7 2UH
About this study
Official title: Effect of Saccharomyces Cerevisiae CNCM I-3856 on Faecal Proteases and Symptoms Associated With IBS-D and Postinfective Bowel Dysfunction
Irritable Bowel Syndrome (IBS) is a common condition characterised by abdominal pain or discomfort and altered bowel habit affecting up to 10% of the population. There are several groups of patients that are based on differing bowel patterns including IBS with diarrhea (IBS-D) and those with post infective IBS (PI-IBS) whose symptoms begin after an acute infection. Saccharomyces cerevisiae, the yeast used in bread making has been shown to reduce the duration of infectious diarrhoea. Part of the benefit maybe that it can destroy bacterial toxins. Recent studies suggest an increase in proteases (chemicals which breakdown proteins) in the stool of patients with IBS-D. The investigators think that this yeast may benefit patients with IBS-D and PI-IBS by reducing the amount of protease in stool. This is important because proteases have been shown to be potentially important in generating some of the discomfort experienced by patients. The investigators will study patients with chronic IBS-D who will receive 2 weeks treatment with the yeast or placebo followed by a 4 week gap and then a further 2 week treatment with placebo or the yeast, with the treatments allocated randomly. The investigators will also study 30 subjects who still have persistent loose bowel function 6 weeks after an infection with Campylobacter jejuni, one of the commonest causes of gastroenteritis in the UK. Subjects will be randomised to take either the yeast or placebo for 4 weeks . In both studies, the investigators will examine the effect of treatment on stool proteases, stool frequency and consistency and abdominal discomfort; the investigators will also take blood samples to examine some aspects of immune system function. The results of the study may suggest how yeast provides a benefit in patients with IBS and diarrhea and will provide data for a larger clinical trial.
Read the detailed description
The participant involvement in study 1 \& 2 will last 15 \& 9 weeks respectively. Study1 has a cross over design so each participant will receive two 2 week treatment periods (1 of placebo and 1 of active) with a 4 week washout period in between. The order with which they receive the treatment will be decided randomly. The study starts with a screening period lasting 1 week. If, at the end of screening, they are still eligible they will be enrolled and start randomised treatment. Once the participant has received both treatments the study finishes.
Study 2 is a parallel group design. Subjects who submit a stool sample which proves to be positive for Campylobacter will be sent an invitation to take part. All subjects will be asked to complete a bowel symptom questionnaire and attend to provide a stool sample (enrolment visit). A blood sample will be taken at this visit.
After a further 4 weeks subjects will attend again, bringing with them a stool sample and stool symptom diaries. A blood sample will be taken. At this time, if they are still symptomatic they will be invited to take part in the randomised placebo controlled trial taking yeast or placebo for 5 weeks, after which they will again attend with stool diaries and provide a final stool and blood sample. The blood sample will be used to see, if antibodies to C. jejuni antigens predicts recovery and whether this is altered by yeast treatment. Those that are asymptomatic will not take part in the RCT but will return at 9 weeks with a further stool and blood sample.
We will also invite 15 healthy volunteers, free from gastrointestinal complaints to attend on 3 occasions mimicking visits 1-3 by providing stool and blood samples so we can define the normal variability in stool composition in health. As with the other subjects they will be required to avoid antibiotics and probiotics during the study.
End of Studies The last visit of the last subject.
SELECTION AND WITHDRAWAL OF PARTICIPANTS Recruitment Study 1 Participants for study 1 will be recruited from Professor Spiller's patients who have previously taken part in research studies and have indicated that they would like to be contacted about future relevant research projects. This secure password protected database is held within the Nottingham Digestive Diseases Centre and contains patient's names and addresses to allow mailing of invitation letter.
The investigator or their nominee, i.e. a member of the participant's usual care team, will make the initial approach to the patient by letter to the patient using a ethically approved invitation letter enclosing a copy of the information sheet and inform the participant of all aspects pertaining to participation in the study.
Study 2 Currently all patients who submit a stool sample positive for C jejuni to the Public Health laboratory receive a letter form Professor Neal asking for details about eating out and pet's illnesses as part of routine surveillance. This letter will have an information sheet enclosed and an invitation to take part in Study 2 We will also recruit 15 healthy volunteers who have responded to an advert displayed on public notice boards at University Hospital Nottingham. On responding, they will then be sent an information sheet and details of the study and who to contact if they are interested in taking part.
- Being tested
- Saccharomyces Cerevisiae CNCM I-3856, placebo
- Keywords
- irritable bowel syndrome, faecal serine proteases
- 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-3856Drug
Saccharomyces cerevisiae CNCM I-3856, 500 mg per capsule (5 X109 living cells). Living cells are estimated by the method of colony forming units (cfu).subjects will take 1 capsule twice a day
placeboDrug
Placebo: Capsules will contain 500 mg of the following formulation and will not contain Saccharomyces cerevisiae CNCM I-3856:
- Calcium phosphate, Dibasic 472.0 mg
- Maltodextrin DE14 112.1 mg
- Vegetal magnesium stearate 5.9 mg subjects will take one capsule twice a day
| Study group | Role | What they receive |
|---|---|---|
| Saccharomyces Cerevisiae CNCM I-3856 | Active comparator | 2 weeks of treatment with Saccharomyces Cerevisiae CNCM I-3856 1 capsule twice a day, 500 mg per capsule (5 X109 living cells). Living cells are estimated by the method of colony forming units (cfu). Receives: Drug: Saccharomyces Cerevisiae CNCM I-3856 |
| placebo | Placebo comparator | Capsules will contain 500 mg of the following formulation and will not contain Saccharomyces cerevisiae CNCM I-3856:
* Calcium phosphate, Dibasic 472.0 mg
* Maltodextrin DE14 112.1 mg
* Vegetal magnesium stearate 5.9 mg subjects will take one capsule twice a day Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in faecal serine protease activity
Measured: at 4 and 9 weeks for study 1 and 10 weeks for study 2
Secondary outcomes (5)
Stool consistency
Measured: at 4 and 9 weeks for study 1 and ten weeks for study 2
Stool frequency
Measured: at 4 and 9 weeks for study 1 and 10 weeks for study 2
Number of mucus septae per high power filed
Measured: at 4 and 9 weeks for study 1 and 10 weeks for study 2
In vitro effect of Saccharomyces cerevisiae CNCM I-3856 supernatant on IBS-D faecal proteases
Measured: at week one for both studies
Bacterial diversity assessed by similarity indices
Measured: at week 1 for both studies at week 4 and 9 for study 1 and week 10 for study 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2009 (estimated)
- Study startJan 2011
- Primary completionJan 2012 (estimated)
- Study completionJul 2012 (estimated)
Why it stopped: unable to get MHRA approval for formulation in present form
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Lesaffre International
- Responsible party
- Sponsor
- Investigators
- Robin Spiller, MB B Chir Cantab, MSc Lond, MD, Principal investigator, Nottingham Digestive Diseases Centre and Biomedical Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00977587
- Sponsor's protocol ID
- 09075
- Status last verified
- Jan 2012
- First submitted
- 15 Sep 2009
- Last updated
- 20 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Saccharomyces Cerevisiae CNCM I-3856 on Faecal Proteases and Symptoms Associated With IBS-D and Postinfective Bowel Dysfunction
- ClinicalTrials.gov ID
- NCT00977587
- Acronym / sponsor ID
- 09075
- Keywords
- irritable bowel syndrome, faecal serine proteases
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: unable to get MHRA approval for formulation in present form
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- Lesaffre International
- Study start
- Jan 2011
- Primary completion
- Jan 2012 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 16 Sep 2009 (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.
Irritable Bowel Syndrome (IBS) is a common condition characterised by abdominal pain or discomfort and altered bowel habit affecting up to 10% of the population. There are several groups of patients that are based on differing bowel patterns including IBS with diarrhea (IBS-D) and those with post infective IBS (PI-IBS) whose symptoms begin after an acute infection. Saccharomyces cerevisiae, the yeast used in bread making has been shown to reduce the duration of infectious diarrhoea. Part of the benefit maybe that it can destroy bacterial toxins. Recent studies suggest an increase in proteases (chemicals which breakdown proteins) in the stool of patients with IBS-D. The investigators think that this yeast may benefit patients with IBS-D and PI-IBS by reducing the amount of protease in stool. This is important because proteases have been shown to be potentially important in generating some of the discomfort experienced by patients. The investigators will study patients with chronic IBS-D who will receive 2 weeks treatment with the yeast or placebo followed by a 4 week gap and then a further 2 week treatment with placebo or the yeast, with the treatments allocated randomly. The investigators will also study 30 subjects who still have persistent loose bowel function 6 weeks after an infection with Campylobacter jejuni, one of the commonest causes of gastroenteritis in the UK. Subjects will be randomised to take either the yeast or placebo for 4 weeks . In both studies, the investigators will examine the effect of treatment on stool proteases, stool frequency and consistency and abdominal discomfort; the investigators will also take blood samples to examine some aspects of immune system function. The results of the study may suggest how yeast provides a benefit in patients with IBS and diarrhea and will provide data for a larger clinical trial.
Detailed description
The participant involvement in study 1 \& 2 will last 15 \& 9 weeks respectively. Study1 has a cross over design so each participant will receive two 2 week treatment periods (1 of placebo and 1 of active) with a 4 week washout period in between. The order with which they receive the treatment will be decided randomly. The study starts with a screening period lasting 1 week. If, at the end of screening, they are still eligible they will be enrolled and start randomised treatment. Once the participant has received both treatments the study finishes.
Study 2 is a parallel group design. Subjects who submit a stool sample which proves to be positive for Campylobacter will be sent an invitation to take part. All subjects will be asked to complete a bowel symptom questionnaire and attend to provide a stool sample (enrolment visit). A blood sample will be taken at this visit.
After a further 4 weeks subjects will attend again, bringing with them a stool sample and stool symptom diaries. A blood sample will be taken. At this time, if they are still symptomatic they will be invited to take part in the randomised placebo controlled trial taking yeast or placebo for 5 weeks, after which they will again attend with stool diaries and provide a final stool and blood sample. The blood sample will be used to see, if antibodies to C. jejuni antigens predicts recovery and whether this is altered by yeast treatment. Those that are asymptomatic will not take part in the RCT but will return at 9 weeks with a further stool and blood sample.
We will also invite 15 healthy volunteers, free from gastrointestinal complaints to attend on 3 occasions mimicking visits 1-3 by providing stool and blood samples so we can define the normal variability in stool composition in health. As with the other subjects they will be required to avoid antibiotics and probiotics during the study.
End of Studies The last visit of the last subject.
SELECTION AND WITHDRAWAL OF PARTICIPANTS Recruitment Study 1 Participants for study 1 will be recruited from Professor Spiller's patients who have previously taken part in research studies and have indicated that they would like to be contacted about future relevant research projects. This secure password protected database is held within the Nottingham Digestive Diseases Centre and contains patient's names and addresses to allow mailing of invitation letter.
The investigator or their nominee, i.e. a member of the participant's usual care team, will make the initial approach to the patient by letter to the patient using a ethically approved invitation letter enclosing a copy of the information sheet and inform the participant of all aspects pertaining to participation in the study.
Study 2 Currently all patients who submit a stool sample positive for C jejuni to the Public Health laboratory receive a letter form Professor Neal asking for details about eating out and pet's illnesses as part of routine surveillance. This letter will have an information sheet enclosed and an invitation to take part in Study 2 We will also recruit 15 healthy volunteers who have responded to an advert displayed on public notice boards at University Hospital Nottingham. On responding, they will then be sent an information sheet and details of the study and who to contact if they are interested in taking part.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saccharomyces Cerevisiae CNCM I-3856 | Active comparator | Drug: Saccharomyces Cerevisiae CNCM I-38562 weeks of treatment with Saccharomyces Cerevisiae CNCM I-3856 1 capsule twice a day, 500 mg per capsule (5 X109 living cells). Living cells are estimated by the method of colony forming units (cfu). |
| placebo | Placebo comparator | Drug: placeboCapsules will contain 500 mg of the following formulation and will not contain Saccharomyces cerevisiae CNCM I-3856: * Calcium phosphate, Dibasic 472.0 mg * Maltodextrin DE14 112.1 mg * Vegetal magnesium stearate 5.9 mg subjects will take one capsule twice a day |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female aged 18-75 years
- Subjects who are able to give informed consent
- IBS-D patients meeting Rome III Criteria
- Subjects with stool cultures positive for Campylobacter jejuni
- Healthy volunteer controls
Key exclusion criteria (9 listed)
- Subjects that, in the opinion of the investigator, are considered unsuitable.
- Subjects who have had abdominal surgery which may cause bowel symptoms similar to IBS (Please note, appendicectomy and cholecystectomy is not an exclusion).
- Subjects with a known intolerance to yeast.
- Subjects taking immunosuppressant medication, e.g. long term steroids, or who might otherwise be immunocompromised.
- Subjects who have had a recent course of antibiotics (in the last 28 days).
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-3856Saccharomyces cerevisiae CNCM I-3856, 500 mg per capsule (5 X109 living cells). Living cells are estimated by the method of colony forming units (cfu).subjects will take 1 capsule twice a day | Drug | Saccharomyces Cerevisiae CNCM I-3856 |
| placeboPlacebo: Capsules will contain 500 mg of the following formulation and will not contain Saccharomyces cerevisiae CNCM I-3856: * Calcium phosphate, Dibasic 472.0 mg * Maltodextrin DE14 112.1 mg * Vegetal magnesium stearate 5.9 mg subjects will take one capsule twice a day | Drug | placebo |
Primary outcome
Change in faecal serine protease activity
Time frame: at 4 and 9 weeks for study 1 and 10 weeks for study 2
5 secondary outcomes
Stool consistency
Time frame: at 4 and 9 weeks for study 1 and ten weeks for study 2
Stool frequency
Time frame: at 4 and 9 weeks for study 1 and 10 weeks for study 2
Number of mucus septae per high power filed
Time frame: at 4 and 9 weeks for study 1 and 10 weeks for study 2
In vitro effect of Saccharomyces cerevisiae CNCM I-3856 supernatant on IBS-D faecal proteases
Time frame: at week one for both studies
Bacterial diversity assessed by similarity indices
Time frame: at week 1 for both studies at week 4 and 9 for study 1 and week 10 for study 2
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2017.
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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.
Robin Spiller, MB B Chir Cantab, MSc Lond, MD principal investigator
Nottingham Digestive Diseases Centre and Biomedical Research Unit
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 and Post Infective Bowel Dysfunction, run by University of Nottingham at 1 site in United Kingdom.
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 8 inclusion and 9 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: withdrawn, as of the sponsor's last update on 20 Jun 2017. 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 United Kingdom. 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 was withdrawn before enrolling participants, so there are no results.
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 in faecal serine protease activity (time frame: at 4 and 9 weeks for study 1 and 10 weeks for study 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jun 2017.