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