E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10012735 |
E.1.2 | Term | Diarrhoea |
E.1.2 | System Organ Class | 10017947 - Gastrointestinal disorders |
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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 demonstrate the efficacy of B clausii probiotic strain (Enterogermina) in combination with oral rehydration therapy (ORT) and Zinc compared to placebo in combination with ORT and Zinc, for a period of 5 days in Indian children with acute diarrhea |
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E.2.2 | Secondary objectives of the trial |
-To evaluate the safety and tolerability of Enterogermina in Indian children with acute diarrhea.
-To evaluate efficacy of Enterogermina on frequency of stool per day.
-To evaluate the impact of Enterogermina on dehydration.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Suffering from acute diarrhea of less than 48 hours duration. Diarrhea is defined as unusual loose or watery stools at least 3 times in previous 24 hours period with no signs of dehydration or some dehydration WHO classification.
- Whose parent/legal guardian has given a written informed consent to participate for his/her child in the study at the time of enrollment.
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E.4 | Principal exclusion criteria |
- Known hypersensitivity to B clausii or any of the excipients or other probiotics.
- Children suffering from chronic gastrointestinal disease (as Crohn’s disease, hemorrhagic recto-colitis, irritable bowel syndrome, short gut syndrome and inflammatory bowel disease).
- History of or current presence of blood (hematochezia), pus, or mucus in stools within the previous 3 months.
- Persistent diarrhea (a diarrhea episode which lasts more than 14 days).
- Clinically significant signs and/or symptoms of parasitic or bacterial diarrhea.
- Severe or persistent vomiting as per Investigator’s judgment.
- Severe dehydration (WHO classification).
- Severe malnutrition defined as <50% weight for age (IAP classification).
- Treatment with antibiotics or antiparasitics within a period of 2 weeks before enrollment.
- Treatment with probiotics or prebiotics within a period of 2 weeks before enrollment: the use of probiotics and prebiotics in dairy food such as yoghurt, cheese, or milk prior to the study is permitted. Formula containing probiotics and prebiotics are forbidden during the study.
- Treatments with anti-diarrhea within 2 weeks before enrollment including but not limited to:
- Anti motility or antiperistaltic drugs (eg, loperamide);
- Adsorbents (eg, diosmectite);
- Anti secretory Drugs (eg, racecadotril);
- Herbal remedies.
- Laxative use within 2 weeks before enrollment.
- Corticosteroids treatment except inhalation, intranasal, ophthalmic and topical formulations within 2 weeks before enrollment. For long term oral or intravenous steroid within 6 months before enrollment.
- History of or current known conditions to produce immunodeficiency:acquired immune deficiency syndrome, other congenital immunodeficiency syndrome, immune-suppressors therapy such as steroids, anticancer drugs, etc.
- Chronic diseases of endocrine, cardiovascular, renal or respiratory system or any other clinically significant condition that can jeopardize patient condition or study outcomes as judged by the Investigator.
- Critically ill patients according to Investigator’s clinical judgment.
- Presence of an indwelling vascular access line.
- Patients with known history of or current pancreatitis.
- History of abdominal surgery.
- Bilious emesis.
- Patient previously enrolled in this study or have participated to another investigational trial within 3 months. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Duration of acute diarrhea (expressed in hours) - Counted from the time of randomization up to recovery (the first normal stool as recorded according to Bristol score; a score <5 is described as normalization of stool). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Randomization time to Day 5 |
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E.5.2 | Secondary end point(s) |
1. Number of patients with Adverse Events (AE) including Serious adverse events (SAE), Adverse event of Special Interest (AESI) - Descriptive analysis (% of AE, SAE and AESI)
2. Frequency of stool per day - Frequency of stool per day: 1 time, 2 times, 3 times, and more than 3 times
3. Dehydration status evaluated - Dehydration status (no dehydration, some dehydration, severe dehydration) evaluated per WHO classification |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. Randomization time to AE recovery
2. and 3. Randomization time to Day 5 |
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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 | Yes |
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 | Yes |
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 |
Will this trial be conducted at a single site globally?
| No |
E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
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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.8.9.2 | In all countries concerned by the trial months | 15 |
E.8.9.2 | In all countries concerned by the trial days | 15 |