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

Antibiotic-associated Diarrhoea research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Antibiotic-associated Diarrhoea

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Dietary Supplement:ProbioticProbiotic formula, 10 billion CFU in total once a day for up to 3 weeks

Dietary Supplement:PlaceboA capsule with microcrystalline cellulose matching the appearance and taste of the active comparator

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

ProbioticProbiotic consumption during and after course of antibiotic

PlaceboPlacebo consumed during and after course of antibiotic

Study Status

Terminated

Start Date: December 2012

Completed Date: December 2014

Phase: Phase 2/Phase 3

Type: Interventional

Design:

Primary Outcome: Incidence of AAD

Secondary Outcome: Duration of diarrhoea

Study sponsors, principal investigator, and references

Principal Investigator: Toivo Piippo, MD

Lead Sponsor: Danisco

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01596829

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