Effects of PRObiotic yoghourt on the prevention of antibiotic-associated DIArrhoea (AAD)
Completed
- Conditions
- Antibiotic-associated diarrhoeaDigestive System
- Registration Number
- ISRCTN46764354
- Lead Sponsor
- niversity Hospital Foundation Alcorcón (Hospital Universitario Fundación Alcorcón) (Spain)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 300
Inclusion Criteria
1. Adults patients, both male and non-pregnant female, older than 18 years who are prescribed amoxycilline-clavulanate or levofloxacin (oral or intravenous) in their treatments and are able to eat and drink
2. Patients or relatives must be able to give written informed consent
Exclusion Criteria
1. Pregnancy
2. Allergy to penicillins or levofloxacin
3. Known lactose intolerance or intolerance to dairy products
4. Diarrhoea on admission or within the preceding week
5. Reported recurrent diarrhoea or bowel disease that could result in diarrhoea
6. Severe immunosuppression
7. Active neoplasia
8. HIV infection
9. Regular probiotic treatment before admission, or laxative use or enema in the 48 hours before admission
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The rate of diarrhoea up to one month after the end of antibiotic therapy. WHO definition of diarrhoea was used: 3 or more loose or watery stools per day for two or more days.
- Secondary Outcome Measures
Name Time Method 1. Severity of diarrhoea defined as the maximum number of stools per day; length of diarrhoea (days with more than two loose stools)<br>2. Necessity to stop antibiotic treatment to treat AAD<br>3. Necessity to use endovenous fluid to treat AAD<br>4. Prolonged hospital admission or readmission because of AAD<br>5. Mortality<br>6. Tolerance to yoghourt and compliance<br><br>All outcomes were evaluated, followed-up for one month.