Infections Digestive System 1. Antibiotic-associated diarrhoea 2. Clostridium difficile infection
Conditions
Interventions
Patients will be randomly allocated to one of two groups. One group will receive a daily Yakult drink for 2 weeks before and 2 weeks after the elective operation. The other group will receive a placeb
Sponsors
St George's University of London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Undergoing elective joint replacement surgery at the Elective Orthopaedic Centre (UK) 2. Must be able to adhere to the protocol requirements 3. Must be capable of giving informed consent 4. At least 18 years old
Exclusion criteria
Exclusion criteria: 1. Diarrhoea on pre-admission or within the preceding week 2. Lactose intolerance or intolerance to dairy products 3. Regular probiotic consumption in the previous 8 weeks 4. Antibiotic use in the previous 4 weeks 5. Patients unable to give written informed consent 6. Immunosuppression 7. Active inflammatory bowel disease or bowel surgery less than 6 months ago, cancer, leukaemia or pancreatitis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of antibiotic-associated diarrhoea during 4 weeks after surgery. This will be assessed in a hospital and then reported by participants following discharge through direct contact with us or records of their bowel habits over the 4 weeks following the operation. The stool chart will then be sent back to us in a pre-paid envelope. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Duration of antibiotic-associated diarrhoea: this will either be recorded directly if the diarrhoea occurs while the patient is still in hospital or by the participant on a stool chart that covers the 4 weeks after the operation. The recorded information is then sent back by the participant in a pre-paid envelope. 2. The incidence of Clostridium difficile diarrhoea, as diagnosed with a positive Clostridium difficile toxin test and stool culture to exclude other enteric pathogens in all patients with undiagnosed diarrhoea. Any inpatients with diarrhoea will have a stool sample sent for analysis, as per standard hospital care. Participants are asked to inform the trialists of the diarrhoea if it occurs in the 4 weeks after surgery, but following discharge from hospital, so that they can have a stool sample taken (as part of standard care). 3. Gastrointestinal symptoms recorded with the Gastrointestinal Symptom Rating Scale before and after surgery. They are recorded face-to-face at the time of consent and at the time of the operation. Participants record the symptoms themselves at 2 weeks and 4 weeks after the surgery and send the results in pre-paid envelopes. | — |
Countries
United Kingdom
Outcome results
None listed