NCT02626104

Bovine Lactoferrin and Antibiotic-associated Diarrhoea.

Bovine Lactoferrin in the Prevention of Antibiotic-associated Diarrhoea in Children - a Randomized Clinical Trial.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 156 (actual)
• Sponsor: Medical University of Warsaw · Academic / Other
• Sex: All
• Age: 1 Year – 18 Years
• Healthy volunteers: Not accepted

Summary

This prospective, randomized, parallel-group, double blind, single-center study is to be conducted in the Medical University of Warsaw Public Paediatric Teaching Hospital in following departments: Department of Paediatric Gastroenterology and Nutrition, Department of Paediatrics and Nephrology, Department of Pediatric Pneumonology and Allergy, Department of Pediatrics with Medical Assessment Unit, Admissions Department. It is planned to include a total of 156 children aged between 12 months to 18 years old receiving antibiotic therapy because of acute respiratory tract infection/or urinary tract infection. The children will be randomly assigned to receive 100 mg of bovine lactoferrin or placebo twice a day orally for the whole period of antibiotic therapy. The primary efficacy parameter is occurrence of diarrhea during the antibiotic therapy and two weeks after, defined as \> 3 stools a day, a watery or loose stool with/or occurrence of blood in the stool.

Conditions

• Antibiotic Associated Diarrhoea

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Bovine lactoferrin	The children will be randomly assigned to receive 100 mg of bovine lactoferrin twice a day orally for the whole period of antibiotic therapy.
DIETARY_SUPPLEMENT	Maltodextrin	The children will be randomly assigned to receive 100 mg of placebo - maltodextrin twice a day orally for the whole period of antibiotic therapy.

Timeline

• Start date: 2015-12-01
• Primary completion: 2017-03-01
• Completion: 2017-03-01
• First posted: 2015-12-10
• Last updated: 2018-06-15

Locations

1 site across 1 country: Poland