E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Antibiotic-associated diarrhea |
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E.1.1.1 | Medical condition in easily understood language |
Antibiotic-associated diarrhea |
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E.1.1.2 | Therapeutic area | Diseases [C] - Symptoms and general pathology [C23] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10002739 |
E.1.2 | Term | Antibiotic-associated diarrhea |
E.1.2 | System Organ Class | 100000004856 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To examine the effect of probiotic capsules on reducing the risk for AAD |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
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E.5.1.1 | 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.
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E.5.2 | Secondary end point(s) |
• Duration of diarrhea
• Severity of diarrhea
• Incidence of CDAD
• Fecal microbiota
• Safety profile |
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E.5.2.1 | 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.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 12 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 16 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 20 |
E.8.9.2 | In all countries concerned by the trial days | 0 |