E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Antibiotic associated diarrhea |
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MedDRA Classification |
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 demonstrate clinical efficacy of new Linex® Forte hard capsules in comparison with placebo regarding frequency of occurrence of diarrhea in treatment with antibiotics |
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E.2.2 | Secondary objectives of the trial |
• to determine the duration of diarrhea • to observe microflora change from beginning to the end of treatment • to determine efficacy in C. difficile diarrhea
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Age between 18 to 70; male or female 2. Subject has been prescribed antibiotic therapy for the duration of at least 7 days to 2 weeks at baseline visit (amoxicillin-clavulanate) 3. Willing to consult with study doctor before any new drug would be taken during the course of their participation 4. Willing not to consume any products containing probiotics during participation in the clinical trial (see Appendix 3) 5. Willing to complete diary card during participation
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E.4 | Principal exclusion criteria |
Hypersensitivity to any of the ingredients or excipients: anhydrous glucose, microcrystal cellulose, potato starch, inulin, oligofructose (glucose, fructose, saccharose), magnesium stearat, hypromellose, titanium dioxide (E171), yellow iron oxide (E172) 2. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorbtion or sucrase-isomaltase insufficiency 3. Allergy to milk proteins 4. Pregnancy or lactation 5. Females of child-bearing potential not using effective contraception, i.e. oral contraception/intrauterine device and/or condoms 6. Immunocompromised patients 7. Unwilling or incapable to give written informed consent or to comply with study directives 8. Patients with diarrhea on entry or within the preceding week 9. Patients with diagnosis of irritable bowel syndrom, Chron disease, bowel pathology that could result in diarrhea 10. Current use of medication is in accordance with the criteria listed in Section 3.4.1.3. (Prohibited medication: Butilscopolamine (Buscopan), metoklopramid (Reglan), domperidon (Tametil), bisakodil (Dulcolax, Novolax), lactulose (Lactecon, Portalac, Prorektal S), lactitol (Importal), glycerol (glycerin globulae)) 11. Use of antibiotic in the previous two weeks
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary endpoint of the trial is to evaluate clinical efficacy of Linex® Forte hard capsules (capsule contains not less than 2 x 109 CFU of lyophillisated lactic acid bacteria Lactobacillus acidophilus (LA-5) and Bifidobacterium animalis subsp. lactis (BB-12) in ratio 1:1) in comparison with placebo as frequency of occurrence of diarrhea in treatment with antibiotics. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Information not present in EudraCT |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Information not present in EudraCT |
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 | Information not present in EudraCT |
E.8.5.1 | Number of sites anticipated in the EEA | 4 |
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 | Information not present in EudraCT |
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 | |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 4 |