Title
Bovine Lactoferrin and Antibiotic-associated Diarrhoea.
Bovine Lactoferrin in the Prevention of Antibiotic-associated Diarrhoea in Children - a Randomized Clinical Trial.
Phase
Phase 2Lead Sponsor
Medical University of WarsawStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Antibiotic Associated DiarrhoeaIntervention/Treatment
maltodextrin bovine lactoferrin ...Study Participants
156This 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.
The children will be randomly assigned to receive 100 mg of bovine lactoferrin twice a day orally for the whole period of antibiotic therapy.
The children will be randomly assigned to receive 100 mg of placebo - maltodextrin twice a day orally for the whole period of antibiotic therapy.
Bovine lactoferrin orally - 100 mg twice a day, for whole antibiotic treatment period.
Maltodextrin orally - 100 mg twice a day, for whole antibiotic treatment period.
Inclusion Criteria: acute respiratory or urinary infection requiring empiric antibiotic therapy. antibiotic treatment started before 24 hours prior to enrollment. the consent of parents or legal guardians to participate in the study Exclusion Criteria: severe or generalized bacterial infection antibiotic therapy during the last 8 weeks use of probiotic during the seven days prior to enrollment immune disorders, chronic disease of the gastrointestinal tract, actual acute or chronic diarrhea, intake of iron supplementation, cows milk protein allergy lack of consent of the parents or legal guardians to participate in the study.
