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OpenTrials
Completed

NCT Number: NCT00457353

ENterogermina® (Bacillus Clausii) In the manaGeMent of diarrheA in Children

Primary:

* To demonstrate the efficacy of Enterogermina® in reducing the duration of acute diarrhea in children

Secondary:

* To evaluate the safety of Enterogermina® in acute diarrhea in Indian children

Completed

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Key information

Conditions

Gastroenteritis Digestive System Diseases Gastrointestinal Diseases

Age range

6 month–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sanofi-Aventis

Mumbai, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Non hospitalised infants and children attending clinic/outpatients with acute diarrhea (>3 liquid or watery stools occurring in a 24-hour period) of less than 48 hours duration

Exclusion criteria

  • History of presence of blood, pus, or mucus in stools
  • Severe dehydration (World Health Organization criteria)
  • Severely malnourished patients
  • Treatment with antibiotics, probiotics, or prebiotics within a period of 2 weeks before enrolment
  • History of conditions known to producing immunodeficiency (Acquired Immune Deficiency Syndrome, other congenital immunodeficiency syndrome, drug therapy with steroids, anticancer drugs etc)
  • Known hypersensitivity to Bacillus clausii or other probiotics.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Treatment and study plan

Bacillus clausii

Drug

For 5 days

Oral rehydration therapy

Other

For 5 days

Primary outcomes

  1. Reduction in duration of diarrhea

    Time frame: Throughout the treatment period

  2. Incidence of adverse events

    Time frame: Throughout the study period

Secondary outcomes

  1. Mean number of stools per day

    Time frame: Throughout the treatment period

  2. Effect on consistency of stools

    Time frame: Throughtout the treatment period

  3. Vomiting episodes per day

    Time frame: Throughout the treatment period

  4. Requirement of unscheduled intravenous transfusion

    Time frame: Throughout the study period

  5. Need for hospitalization

    Time frame: Throughout the treatment period

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

Phase III Comparative Study to Assess the Efficacy and Safety of Oral Rehydration Therapy (ORT) in Combination With Spores of Bacillus Clausii (Enterogermina)Versus ORT Alone, Administered for 5 Days With the Treatment of Acute Diarrhea in Children.

Acronym: ENIGMA

Important dates

Study start
2007
Primary completion
2007
First posted
Apr 6, 2007
Registry last updated
Jan 21, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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