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 Beutel)

Multicentre, prospective, double-blind, two-armed, placebo-controlled phase III study to evaluate the efficacy and safety of the treatment of diarrhoea with Lactobacillus rhamnosus GG (InfectoDiarrstop LGG Mono Beutel) in infants and toddlers - Diarrhoea therapy with Lactobacillus rhamnosus GG

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-002291-13-DE

Enrollment

150

Registered

2012-07-13

Start date

2012-10-19

Completion date

Unknown

Last updated

2014-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute diarrhoea in infants and toddlers MedDRA version: 14.1 Level: LLT Classification code 10000706 Term: Acute diarrhea System Organ Class: 100000004856

Interventions

Trade Name: Infectodiarrstop LGG Mono Beutel Pharmaceutical Form: Powder for oral suspension INN or Proposed INN: Lactobacillus rhamnosus GG CAS Number: ./. Current Sponsor code: ./. Other descriptive

Eligibility

Sex/Gender

All

Inclusion criteria

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

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 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

Design outcomes

Primary

Measure	Time frame
Main Objective: Duration of diarrhoea (time until therapeutic success, i.e. end of diarrhoea, defined as = 3 watery and/or loose stools per day during the past 2 days without recurrence of the diarrhoea until the end of the treatment);Secondary Objective: • Therapeutic success at the control visit on Day 5 • Therapeutic success at the final examination on Day 10 • Termination due to inefficacy on Day 2 and until Day 10 • Number of watery and/or loose stools on each day during the treatment phase • Number of bloody stools on each day during the treatment phase • Number of patients with vomiting analysed for each day during the treatment phase • Dropout cases (number and reasons) • Adverse events (AEs) (incl. seriousness and relationship to trial drug) ;Primary end point(s): The primary efficacy variable is the duration of diarrhoea. Duration of diarrhoea is defined as the time from randomisation to the end of diarrhoea (defined as = 3 watery and/or loose stools per day during the past 2 days without recurrence of the diarrhoea until the end of the treatment). The first day without diarrhoea will be the day of end of diarrhoea. This definition also applies to patients who prematurely terminate the treatment with = 3 watery and/or loose stools per day during the past 2 days (i.e. due to an already reached “end of diarrhoea”). ;Timepoint(s) of evaluation of this end point: Presumably March 2014	—

Measure

Time frame

Main Objective: Duration of diarrhoea (time until therapeutic success, i.e. end of diarrhoea, defined as = 3 watery and/or loose stools per day during the past 2 days without recurrence of the diarrhoea until the end of the treatment);Secondary Objective: • Therapeutic success at the control visit on Day 5 • Therapeutic success at the final examination on Day 10 • Termination due to inefficacy on Day 2 and until Day 10 • Number of watery and/or loose stools on each day during the treatment phase • Number of bloody stools on each day during the treatment phase • Number of patients with vomiting analysed for each day during the treatment phase • Dropout cases (number and reasons) • Adverse events (AEs) (incl. seriousness and relationship to trial drug) ;Primary end point(s): The primary efficacy variable is the duration of diarrhoea. Duration of diarrhoea is defined as the time from randomisation to the end of diarrhoea (defined as = 3 watery and/or loose stools per day during the past 2 days without recurrence of the diarrhoea until the end of the treatment). The first day without diarrhoea will be the day of end of diarrhoea. This definition also applies to patients who prematurely terminate the treatment with = 3 watery and/or loose stools per day during the past 2 days (i.e. due to an already reached “end of diarrhoea”). ;Timepoint(s) of evaluation of this end point: Presumably March 2014

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Secondary

Measure	Time frame
Secondary end point(s): Therapeutic success at the control visit on Day 5 (=yes, if end of diarrhoea defined as = 3 watery and/or loose stools per day during the past 2 days without recurrence of the diarrhoea until Day 10, otherwise =no) Therapeutic success at the final examination on Day 10 (=yes, if end of diarrhoea defined as = 3 watery and/or loose stools per day during the past 2 days without recurrence of the diarrhoea until Day 10, otherwise =no) Termination due to inefficacy on Day 2 and until Day 10 Number of watery and/or loose stools on each day during the treatment phase Number of bloody stools on each day during the treatment phase Number of patients with vomiting analysed for each day during the treatment phase Grade of dehydration (the grade of dehydration will be determined by the investigator at each visit as mild ( 10%)) ;Timepoint(s) of evaluation of this end point: Presumably March 2014	—

Measure

Time frame

Secondary end point(s): Therapeutic success at the control visit on Day 5 (=yes, if end of diarrhoea defined as = 3 watery and/or loose stools per day during the past 2 days without recurrence of the diarrhoea until Day 10, otherwise =no) Therapeutic success at the final examination on Day 10 (=yes, if end of diarrhoea defined as = 3 watery and/or loose stools per day during the past 2 days without recurrence of the diarrhoea until Day 10, otherwise =no) Termination due to inefficacy on Day 2 and until Day 10 Number of watery and/or loose stools on each day during the treatment phase Number of bloody stools on each day during the treatment phase Number of patients with vomiting analysed for each day during the treatment phase Grade of dehydration (the grade of dehydration will be determined by the investigator at each visit as mild ( 10%)) ;Timepoint(s) of evaluation of this end point: Presumably March 2014

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Countries

Germany, Poland, Ukraine

Contacts

Public ContactProject Manager

Ecron Acunova GmbH

Simon.Berberich@ecronacunova.com+496966 80 30 0

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026