TEDDY: Spores of Bacillus Clausii in Acute Diarrhoea in Children

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Spores of Bacillus Clausii Probiotic Strain

About this trial

This is an interventional treatment trial for Diarrhea

Eligibility Criteria

6 Months - 36 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion criteria: Infants or Children Non hospitalized infants or children With acute diarrhea evident for less than 48 hours Having had three or more watery stools during the preceding 24 hours Exclusion criteria: Infants or Children With blood stools Having been treated with antibiotics or probiotics within the two weeks before the enrollment Suffering from dehydration defined by a weight loss of at least 5% or by the presence of a skin fold With an history of seizures With immunosuppressive conditions With a current status requiring an antibiotic treatment Suffering from a chronic disease including chronic diarrhea whatever the origin Having received before inclusion one of the following treatments: Probiotics Prebiotics Drugs with adsorbing properties Drugs that modify intestinal secretion like bismuth subsalicylate, acetorphan Drugs that modify intestinal motility (opiates such as loperamide, atropine and other cholinergic agents). Having participated in another clinical trial in the last 3 months prior to the start of the study

Sites / Locations

Sanofi-Aventis
Sanofi-Aventis

Outcomes

Primary Outcome Measures

Duration of diarrhoea as counted from the first intake of the investigational product up to the first appearance of a loose stool followed by two-consecutive normal stools

Secondary Outcome Measures

Number of infants/children with normal stools at D3, D4, D5, D6 and D7;Mean number of stools per day;Occurrence of vomiting episodes per day after enrolment;Parents'overall global assessment of efficacy at the end of the treatment;other safety criteria

Full Information

NCT ID

NCT00265369

First Posted

November 4, 2005

Last Updated

January 10, 2011

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00265369

Brief Title

TEDDY: Spores of Bacillus Clausii in Acute Diarrhoea in Children

Official Title

Comparative Efficacy and Safety of a Bacillus Clausii Probiotic Strain Versus Placebo in the Treatment of Acute Diarrhoea in Children

Study Type

Interventional

2. Study Status

Record Verification Date

January 2011

Overall Recruitment Status

Completed

Study Start Date

May 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Sanofi

4. Oversight

5. Study Description

Brief Summary

Primary objective: To demonstrate the efficacy of a Bacillus clausii probiotic strain compared to placebo in children suffering from acute diarrhoea and treated for 7 days. Secondary objective: To evaluate the clinical safety of the Bacillus clausii probiotic strain versus placebo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diarrhea

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

420 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Spores of Bacillus Clausii Probiotic Strain

Primary Outcome Measure Information:

Title

Duration of diarrhoea as counted from the first intake of the investigational product up to the first appearance of a loose stool followed by two-consecutive normal stools

Secondary Outcome Measure Information:

Title

Number of infants/children with normal stools at D3, D4, D5, D6 and D7;Mean number of stools per day;Occurrence of vomiting episodes per day after enrolment;Parents'overall global assessment of efficacy at the end of the treatment;other safety criteria

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

36 Months

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion criteria: Infants or Children Non hospitalized infants or children With acute diarrhea evident for less than 48 hours Having had three or more watery stools during the preceding 24 hours Exclusion criteria: Infants or Children With blood stools Having been treated with antibiotics or probiotics within the two weeks before the enrollment Suffering from dehydration defined by a weight loss of at least 5% or by the presence of a skin fold With an history of seizures With immunosuppressive conditions With a current status requiring an antibiotic treatment Suffering from a chronic disease including chronic diarrhea whatever the origin Having received before inclusion one of the following treatments: Probiotics Prebiotics Drugs with adsorbing properties Drugs that modify intestinal secretion like bismuth subsalicylate, acetorphan Drugs that modify intestinal motility (opiates such as loperamide, atropine and other cholinergic agents). Having participated in another clinical trial in the last 3 months prior to the start of the study

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gilles Perdriset, MD

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Sanofi-Aventis

City

Brussels

Country

Belgium

Facility Name

Sanofi-Aventis

City

Paris

Country

France

Diarrhea

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial