Antibiotic-associated diarrhea MedDRA version: 16.1 Level: LLT Classification code 10002739 Term: Antibiotic-associated diarrhea System Organ Class: 100000004856
Conditions
Interventions
Sponsors
DuPont Nutrition and Health Active Nutrition
Eligibility
Sex/Gender
All
Inclusion criteria
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 (e.g. amoxicillin or ampicillin alone or in combination with betalactamase inhibitors); narrow spectrum penicillins (e.g. isoxazolylpenicillin, phenoxymethylpenicillin); cephalosporins; doxicyclin (or other tetracyclins); clarithromycin (or other macrolides) (e.g. erythromycin, azithromycin); ciprofloxacin (or other fluoroquinolones) (e.g. levofloxacin, norfloxacin), nitrofurantoin, trimethoprim and sulfadiazine. 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 34.9. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 380 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
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 and watery stools/ 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 (vegetal source), ascorbic acid, Colloidal silicon dioxide). 7. Presence of an active, non-controlled diagnosed intestinal disease (e.g.Crohn’s Disease, ulcerative colitis, celiac disease). NOTE: Detected and symtomless Helicobacter pylori infection is NOT an exclusion criterion. 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 (e.g. amoxicillin or ampicillin alone or in combination with betalactamase inhibitors), narrow spectrum penicillins (e.g. isoxazolylpenicillin, phenoxymethylpenicillin), cephalosporins, doxicyclin (or other tetracyclins) or ciprofloxacin (or other fluoroquinolones) (e.g. levofloxacin, norfloxacin), nitrofurantoin, trimethoprim and sulfadiazine for the treatment of an infection. 14. History of drug or alcohol abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To examine the effect of probiotic capsules on reducing the risk for AAD;Secondary Objective: To examine the effect of probiotic capsules on reducing the risk for AAD. To assess the response effect of probiotic capsules on the duration and severity of AAD. To assess the response effect probiotic capsules on fecal microbiota. To assess the response effect of probiotic capsules on product safety.;Primary end point(s): • Incidence of AAD;Timepoint(s) of evaluation of this end point: The incidence of AAD will be determined by recording any episode of diarrhea during the antibiotic treatment period and at any time until the end of study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Duration of diarrhea • Severity of diarrhea • Incidence of CDAD • Fecal microbiota • Safety profile;Timepoint(s) of evaluation of this end point: • Duration of diarrhea will be recorded at every episode of diarrhea. • Severity of diarrhea will be recorded at every episode of diarrhea. • Incidence of CDAD will be determined at every episode of diarrhea. • Fecal microbiota will be determined at baseline, during the antibiotic treatment period, during the 7-day period with study product only and at the end of study. • Safety profile will be followed by recording all adverse events daily during the antibiotic treatment period, during the 7-day period with study product only and during the 21-day follow-up period. | — |
Countries
Sweden
Contacts
Public ContactAnneli Tarpila
Danisco Sweeteners Oy
Outcome results
None listed