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Register:	ISRCTN
Last refreshed on:	3 March 2020
Main ID:	ISRCTN12619517
Date of registration:	18/01/2015
Prospective Registration:	No
Primary sponsor:	St George's University of London
Public title:	Effects of fermented milk on prevention of antibiotic-associated diarrhoea and Clostridium difficile infection in patients undergoing planned bone surgery
Scientific title:	Effects of Yakult (Lactobacillus casei Shirota) on prevention of antibiotic-associated diarrhoea and Clostridium difficile infection in patients undergoing elective orthopaedic surgery
Date of first enrolment:	21/07/2011
Target sample size:	1100
Recruitment status:	Completed
URL:	http://isrctn.com/ISRCTN12619517
Study type:	Interventional
Study design:	Single-centre double-blind randomised placebo-controlled study (Prevention)
Phase:	Not Applicable

Countries of recruitment
United Kingdom

Contacts

Name:	Carl Moran
Address:	St Richard's Hospital Spitalfield Lane PO19 6SE Chichester United Kingdom
Telephone:
Email:
Affiliation:

Name:
Address:
Telephone:
Email:
Affiliation:

Key inclusion & exclusion 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:
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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Infections
Digestive System
1. Antibiotic-associated diarrhoea 2. Clostridium difficile infection

Intervention(s)

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 placebo version of the drink for the same period. The placebo drink will not have the active ingredient of Yakult, but will look and taste identical and will be packaged in the same way. The placebo drink will also be manufactured by Yakult.

Primary Outcome(s)

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 Outcome(s)

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.

Secondary ID(s)

Source(s) of Monetary Support

Yakult UK Ltd (UK), Elective Orthopaedic Centre (UK), St George's Charitable Trust (UK)

Secondary Sponsor(s)

Ethics review

Status:
Approval date:
Contact:

National Research Ethics Service, North London REC 3, 27/09/2010, ref: 10/H0709/52

Results

Results available:	Yes
Date Posted:
Date Completed:	01/08/2014
URL:

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