ClinicalTrials.Veeva

Menu

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

P

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

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

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

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems