Efficacy and Safety of a Probiotic Product in Children With Antibiotic-associated Gastrointestinal Disorders.

Probi AB

Status and phase: Completed; Phase 2

Conditions: Antibiotic-associated Loose/Watery Stools

Treatments: Dietary Supplement: Placebo capsules; Dietary Supplement: Probiotic capsules

Study type: Interventional

Funder types: Industry

Identifiers

NCT01940913

ProAAD

Details and patient eligibility

About

To assess the tolerability and effect of a probiotic product, when co-administered with antibiotics, on the incidence and duration of loose/watery stools following the antibiotic treatment in children.

Enrollment: 400 estimated patients

Sex: All

Ages: 1 to 11 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

1. Children at the age of 1-11 years that have been ordinated to start antibiotic treatment except for penicillin.
2. Possibility to initiate the probiotic treatment within 24 hours after the first dose of the antibiotic treatment.
3. Children whose parents or legal caregivers have signed the informed consent to participate in the study.

Exclusion criteria

1. Chronic intestinal disease.
2. Current immunodeficiency or immunosuppressive treatment.
3. Chronic or acute diarrhoeal disease.
4. Use of laxatives the week before inclusion in the study.
5. Antibiotic treatment for the last four weeks before inclusion in the study.
6. Known hypersensitivity to any of the ingredients in the probiotic product or the placebo [potato starch, silicon dioxide, capsule (hypromellose, water) ± bacterial culture].
7. Intake of any probiotic products for the last two weeks before inclusion in the study.
8. Patient requiring hospitalisation. Lack of parents´/legal guardians´ informed consent.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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400 participants in 2 patient groups, including a placebo group

Probiotics

Active Comparator group

Treatment:

Dietary Supplement: Probiotic capsules

Placebo

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo capsules