Effect of Probiotic Formula on Reducing the Risk for Antibiotic-associated Diarrhoea

Phase 2

Terminated

• Conditions: Antibiotic-associated Diarrhoea
• Interventions: Dietary Supplement: Probiotic; Dietary Supplement: Placebo

• Registration Number: NCT01596829
• Lead Sponsor: Danisco

Brief Summary

Antibiotic treatment disturbs the balance of the intestinal microbiota and predisposes to antibiotic associated diarrhea. Previous studies have shown that the risk of developing diarrhea during a course of antibiotics may be reduced by simultaneous consumption of probiotics. The aim of the present study is to assess the effect of a probiotic formula containing four strains on reducing the risk of antibiotic associated diarrhea.

Detailed Description

The aim of the study is to assess the effect of a probiotic formula on reducing the risk of antibiotic-associated diarrhea (AAD). The study will be conducted as a two-arm, parallel groups, placebo-controlled, double-blind, randomized clinical trial, stratified by age, gender and number of days on antibiotics. The duration of patient participation in the study will be up to 7 weeks (up to 3 weeks supplementation, 4 weeks follow-up). The overall duration of the study is expected to be approximately 8 months. Adult males and females that are prescribed antibiotic therapy for minimum of 3 and a maximum of 14 days will be included in the study. The incidence of AAD will be evaluated as the primary end-point. The stool from patients presenting diarrhea will be tested for the presence of Clostridium difficile and if negative for C. difficile, also for the presence of other common pathogens causing diarrhea. The overall microbiota will be analyzed from fecal samples taken regularly during each phase of the study.

Study Timeline

• Study First Submitted: 2012-05-08
• Study First Submitted QC: 2012-05-09
• Study First Posted: 2012-05-11
• Study Start: 2012-12
• Status Verified: 2014-12
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Last Update Submitted: 2016-01-21
• Last Update Posted: 2016-01-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 258

Inclusion Criteria

1. Males and females aged 18-65 years.
2. Patients will be initiating antibiotic therapy.
3. The antibiotic therapy consists of one of the following: broad spectrum penicillins, cephalosporins, doxycycline, clarithromycin, ciprofloxacin or isoxazolyl penicillin.
4. The antibiotic therapy is expected to be 3 to 14 days in duration.
5. Obtained his/her informed consent after verbal and written information.
6. Have a high probability for compliance with and completion of the study.
7. Patients having a telephone available.
8. Body Mass Index between 19 and 30.

Exclusion Criteria

1. Participation in a clinical trial with an investigational product or drug within the 60 days prior to screening.
2. Likeliness to be noncompliant with the protocol, or to be unsuitable to the study by the investigator for any reason.
3. Pregnant or breastfeeding women; women planning to become pregnant during the study months.
4. Presence of active diarrhea (3 or more loose or watery stools per 24 hour period).
5. Daily consumption of probiotics, fermented milk and/or yogurt with probiotics.
6. Known to have a previous reaction, including anaphylaxis, to any substance in composition of the study product (i.e. on-medicinal ingredients: Cellulose, hypromellose, magnesium stearate (vegetable source), ascorbic acid, Colloidal silicon dioxide).
7. Presence of an active, non-controlled intestinal disease such as Crohn's Disease or ulcerative colitis.
8. Regular use of proton pump inhibitors.
9. Bowel surgery, artificial heart valve, history of rheumatic heart disease or infective endocarditis.
10. A previous documented C. difficile infection < 3 months prior to study initiation.
11. Immunosuppressive therapy or any health condition causing immunosuppression (including haematological malignancies, AIDS).
12. Ongoing or recent use of antibiotic therapy in the 3 months prior to the study product first administration.
13. Planned administration of antibiotics other than broad spectrum penicillins, cephalosporins, doxycycline, ciprofloxacin or isoxazolyl penicillin for the treatment of an infection.
14. History of drug or alcohol abuse.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic	Probiotic	Probiotic consumption during and after course of antibiotic
Placebo	Placebo	Placebo consumed during and after course of antibiotic

Primary Outcome Measures

Name	Time	Method
Incidence of AAD	Up to 21 days	Incidence of diarrhoea defined as three or more loose or watery stools per a 24 h period.

Secondary Outcome Measures

Name	Time	Method
Duration of diarrhoea	Up to 21 days	Number of continuous days of diarrhoea
Fecal microbiota	Up to 21 days	Analysis of overall microbiota from all samples and of causative diarrhoeal agent from samples taken during diarrhoeal episode
Safety profile	Up to 21 days	Evaluation of serious and non-serious adverse events

Trial Locations

Locations (1)

Koskiklinikka; 🇫🇮 Tampere, Finland