Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
N0265122366
Study information
Scientific title
A double blind, randomised, placebo controlled trial investigating the efficacy and role of Synbiotic Cocktail 2000 in the treatment of Clostridium difficile diarrhoea and colitis
Acronym
Study hypothesis
1. To assess the role of Synbiotic Cocktail 2000 on symptom duration and relapse rates in patients with one or more episodes of C. difficile diarrhoea
2. To confirm the safety, tolerance and efficacy of Synbiotic Cocktail 2000 used with metronidazole for treatment of C. difficile diarrhoea and colitis compared with metronidazole and placebo
3. To assess the rate of C. difficile toxin and C. difficile elimination with Synbiotic Cocktail 2000 when compared to placebo
4. To investigate the ability of Synbiotic Cocktail 2000 to inhibit C. difficile and Toxin A production in vitro
5. To investigate the efficacy and duration of human gut colonisation by Synbiotic Cocktail 2000 during and after treatment
6. To investigate and characterise mucosa-associated bacteria in patients with antibiotic associated colitis before and after treatment with Synbiotic Cocktail 2000
Ethics approval(s)
Not provided at time of registration
Study design
Double-blind randomised placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Condition
Clostridium difficile diarrhoea and colitis
Intervention
Treatment will be initiated at the time of acute relapse and patients will commence on oral metronidazole with either probiotic or placebo. Antibiotic therapy will be continued for seven days while probiotic or placebo will continue for three weeks. Any relapse in symptoms will require oral vancomycin. Stool samples will be obtained daily during initial metronidazole therapy until two stool samples are negative for C. difficile toxin. Daily stool diaries will be kept by all patients. At the end of the three week period of probiotic therapy, patients will undergo a rigid sigmoidoscopy examination and one rectosigmoid biopsy obtained for culture.
Intervention type
Other
Primary outcome measure
Disease relapse over one month
Secondary outcome measures
1. Disease relapse over three months
2. Rate of loss of C. difficile and toxin from the stool
3. Time to resolution of diarrhoea
Overall study start date
16/01/2003
Overall study end date
16/01/2004
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Any patient with a stool sample positive for Toxin A and clinically symptomatic in the Trust will be offered entry into the trial.
ASSESSMENT ON ADMISSION INTO TRIAL:
1. History and physical examination
2. Blood tests
3. Stool analysis for C. difficile and Toxin A
4. Rigid or flexible sigmoidoscopy with biopsies
Participant type(s)
Patient
Age group
Not Specified
Sex
Not Specified
Target number of participants
120
Participant exclusion criteria
Patients may be removed from the study if one or more of the following occurs:
1. Protocol violation or non-compliance on part of the patient
2. 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)
Recruitment start date
16/01/2003
Recruitment end date
16/01/2004
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
Selly Oak Hospital
Birmingham
B29 6JD
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
University Hospital Birmingham NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|