Bacterial supplementation as treatment for the irritable bowel syndrome: a randomised double-blind placebo-controlled study
| ISRCTN | ISRCTN33705865 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33705865 |
| Protocol serial number | N0265122367 |
| Sponsor | Department of Health (UK) |
| Funder | University Hospital Birmingham NHS Trust (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 16/02/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr S Pathmakanthan
Scientific
Scientific
GI Medicine
Selly Oak Hospital
Birmingham
B29 6JD
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Double-blind randomised placebo-controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Bacterial supplementation as treatment for the irritable bowel syndrome: a randomised double-blind placebo-controlled study |
| Study objectives | To assess the tolerance and efficacy of Synbiotic Cocktail 2000 in symptom reduction in the irritable bowel syndrome. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Digestive System: Irritable bowel syndrome (IBS) |
| Intervention | ASSESSMENT ON ADMISSION INTO TRIAL: History and examination, normal blood tests and a previously normal flexible sigmoidoscopy. ASSESSMENT DURING STUDY PERIOD: All patients will be randomised to receive either the placebo or Synbiotic cocktail 2000 daily for 8 weeks. Prior to this period, there will be a run in period of 2 weeks where patients will record baseline gastrointestinal symptoms on a weekly basis as well as bowel frequency and consistency on a daily basis. A previously validated patient diary will be used scoring abdominal pain, bloating, number and consistency of stool and level of flatulence completed on a weekly basis. After the 2 week run in period, a study period involving Synbiotic or placebo intake will last for 8 weeks. A final questionnaire would be sent out to all patients 6 months post study period, using the same format. Prior to commencement and directly after treatment or placebo period, patients will undergo a hydrogen breath test to ensure bacterial supplementation has not resulted in bacterial overgrowth. REMOVAL FROM STUDY: Patients may be removed from the study if one or more of the following occurs: Protocol violation or non-compliance on part of the patient, refusal of the patient to continue treatment and a decision by the investigator that termination is in the patient's best medical interest (or a significant unrelated medical illness or complication). |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Synbiotic Cocktail 2000 |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 13/04/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | All |
| Sex | All |
| Target sample size at registration | 100 |
| Key inclusion criteria | 1. Any patient seen in gastroenterology outpatient clinics at University Hospital Birmingham who fulfils the Rome criteria II for IBS would be offered entry into the trial 2. Patients without a history of malabsorption, previous abdominal surgery, diverticulitis or other organic intestinal disease |
| Key exclusion criteria | 1. Pregnancy 2. Any form of mental disorder 3. Severe systemic illness |
| Date of first enrolment | 13/04/2003 |
| Date of final enrolment | 13/04/2008 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
GI Medicine
Birmingham
B29 6JD
United Kingdom
B29 6JD
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
