International trial involving numerous sites in several countries to investigate the efficacy in shortening diarrhoea and safety for small children (infants and toddlers) by treatment with Lactobacillus rhamnosus GG (brand name: InfectoDiarrstop LGG Mono)

• Conditions: Acute diarrhoea in infants and toddlers; MedDRA version: 14.1Level: LLTClassification code 10000706Term: Acute diarrheaSystem Organ Class: 100000004856; Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]

• Registration Number: EUCTR2012-002291-13-PL
• Lead Sponsor: InfectoPharm - Arzneimittel und Consilium GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-22
• Last Update Posted: 16 December 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Informed consent to trial participation in writing encompassing consent to data recording and verification procedures, is to be given by both parents (or legal representatives, if applicable) of the patient before the first administration of trial medication
• Male or female infants or toddlers aged 28 days to 24 months
• Clinical diagnosis of diarrhoea (> 3 watery and/or loose stools during the past 24 hours)

Are the trial subjects under 18? yes
Number of subjects for this age range: 150
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Diarrhoea for more than 3 days (72 hours)
• Diarrhoea after stay abroad
• Bloody stools
• Fever
• Dehydration > 5% (loss in weight)
• Systemic treatment with antibiotics (currently or during the past 24 hours)
• Malnutrition (according to clinician’s assessment)
• Severe or chronic disease of the gastrointestinal tract
• Short bowel syndrome
• Phenylketonuria
• Clinically relevant primary or secondary immunodeficiency
• Malignant tumour, chemotherapy, or radiotherapy (currently or during the past 6 months)
• Other severe diseases that the investigator assesses as conflicting with the participation
• Premature infants (gestational age < 38 weeks)
• Lactose intolerance
• Hypersensitivity to the active pharmaceutical ingredient or any other ingredient of the trial medication
• Intake of highly dosed probiotics (> one billion of colony forming units (CFU)/day during the past 7 days before inclusion)
• Other antidiarrhoeal medical therapies (currently or during the past 7 days)
• Inability of the parents to understand the instructions of the trial
• Obvious unreliability of the parents or missing willingness to cooperate
• Known addiction of the parents to alcohol, medicaments, or drugs
• Dependency of the child or the parents on the sponsor or on an investigator
• Participation in a clinical trial during the past 30 days
• Participation of a sibling in the present clinical trial
• Previous participation in the present clinical trial

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified