Bovine Lactoferrin and Antibiotic-associated Diarrhoea.

Medical University of Warsaw156 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

156

Conditions

Antibiotic Associated Diarrhoea

Interventions

Eligibility

Sex: ALLMin age: 1 YearMax age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Occurence of antibiotic-associated diarrhoea.

Occurrence of diarrhea up to 24 days after initiation of antibiotic treatment, defined as \> 3 stools a day, a watery or loose stool with/or occurrence of blood in the stool.

Time frame: Up to 24 days after initiation of antibiotic treatment.

Secondary Outcomes

Discontinuation of antibiotic treatment due to the antibiotic - diarrhoea.

Time frame: Up to 10 days after initiation of antibiotic treatment.

Intravenous rehydration due to the antibiotic-associated diarrhea