Clostridium difficile diarrhoea and colitis Infections and Infestations Other bacterial intestinal infections
Conditions
Interventions
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 pr
Sponsors
Record provided by the NHS Trusts Clinical Trials Register - Department of Health (UK)
Eligibility
Inclusion criteria
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
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease relapse over one month. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Disease relapse over three months 2. Rate of loss of C. difficile and toxin from the stool 3. Time to resolution of diarrhoea | — |
Countries
United Kingdom
Outcome results
None listed