Preventing Childhood Antibiotic-associated Diarrhea by Prebiotics (WGAAD)

Soroka University Medical Center

Status and phase: Completed; Phase 3

Conditions: Antibiotic-Associated Diarrhea

Treatments: Dietary Supplement: Inulin and fructo-oligosaccharides.; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00826137

Sor472908ctil

Details and patient eligibility

About

Prospective randomized double-blind study on the effect of prebiotics (inulin and fructo-oligosaccharides) in the prevention of antibiotic-associated diarrhea in children.

Full description

Group will get either the product or placebo blindly throughout antibiotic treatment with additional 14 days.

Enrollment: 200 patients

Sex: All

Ages: 6 months to 14 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Healthy children with acute infection.

Exclusion criteria

• Hypersensitivity to antibiotics, chronic illness.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups, including a placebo group

A

Experimental group

Description:

Treated with prebiotics.

Treatment:

Dietary Supplement: Inulin and fructo-oligosaccharides.

B

Placebo Comparator group

Description:

Placebo treated.

Treatment:

Dietary Supplement: Placebo