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Effects of PRObiotic yoghourt on the prevention of antibiotic-associated DIArrhoea (AAD)

Probiotic yoghourt for the prevention of antibiotic-associated diarrhoea in adults: a randomized double blind placebo-controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN46764354
Enrollment
300
Registered
2013-09-18
Start date
2005-05-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antibiotic-associated diarrhoea Digestive System

Interventions

Patients were randomized (2:2:1) to receive 200 ml of: 1. placebo yoghourt (S. thermophilus 10^9 ufc/ml, L bulgaricus 10^7 ufc/ml), (placebo group) 2. probiotic yoghourt (previous plus L. acidophilus

Sponsors

University Hospital Foundation Alcorcón (Hospital Universitario Fundación Alcorcón) (Spain)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
1. Severity of diarrhoea defined as the maximum number of stools per day; length of diarrhoea (days with more than two loose stools) 2. Necessity to stop antibiotic treatment to treat AAD 3. Necessity to use endovenous fluid to treat AAD 4. Prolonged hospital admission or readmission because of AAD 5. Mortality 6. Tolerance to yoghourt and compliance All outcomes were evaluated, followed-up for one month.

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026