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

Sanofi

Status and phase: Completed; Phase 3

Conditions: Gastroenteritis

Treatments: Other: Oral rehydration therapy; Drug: Bacillus Clausii

Study type: Interventional

Funder types: Industry

Identifiers

NCT00457353

ENTER_L_01486

Details and patient eligibility

About

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

Enrollment: 264 patients

Sex: All

Ages: 6 months to 5 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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264 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

Administration of oral rehydration therapy with Bacillus clausii probiotic strain (1 vial twice daily, each vial containing 2 billion spores of Bacillus clausii)

Treatment:

Drug: Bacillus Clausii

2

Placebo Comparator group

Description:

Administration of Oral rehydration therapy

Treatment:

Other: Oral rehydration therapy