An interventional study of Saccharomyces Cerevisiae CNCM I-3856 and placebo in Irritable Bowel Syndrome and Post Infective Bowel Dysfunction, sponsored by University of Nottingham. Withdrawn at 1 site in United Kingdom. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-06-20.
Sponsored by University of Nottingham · Not applicable, Interventional, and Treatment
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.
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.
1,062 studies on the registry are indexed under Irritable Bowel Syndrome; 190 are open to participants now.
Browse Irritable Bowel Syndrome studies →University of Nottingham is the lead sponsor of 455 studies on the registry; 77 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Study 1 and 2:
Study 1:
Study 2:
Exclusion Criteria:
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).
Drug: Saccharomyces Cerevisiae CNCM I-3856
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
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
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
Change in faecal serine protease activity
Time frame: at 4 and 9 weeks for study 1 and 10 weeks for study 2
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
This study is withdrawn, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Nottingham