Bovine Lactoferrin and Antibiotic-associated Diarrhoea.

Phase 2

Completed

• Conditions: Antibiotic Associated Diarrhoea
• Interventions: Dietary Supplement: Bovine lactoferrin; Dietary Supplement: Maltodextrin

• Registration Number: NCT02626104
• Lead Sponsor: Medical University of Warsaw

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-06-29
• Status Verified: 2015-11
• Study Start: 2015-12
• Study First Submitted QC: 2015-12-09
• Study First Posted: 2015-12-10
• Primary Completion: 2017-03-01
• Study Completion: 2017-03-01
• Last Update Submitted: 2018-06-14
• Last Update Posted: 2018-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 156

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A - Lactoferrin	Bovine lactoferrin	Bovine lactoferrin orally - 100 mg twice a day, for whole antibiotic treatment period.
B - Maltodextrin	Maltodextrin	Maltodextrin orally - 100 mg twice a day, for whole antibiotic treatment period.

Primary Outcome Measures

Name	Time	Method
Occurence of antibiotic-associated diarrhoea.	Up to 24 days after initiation of antibiotic treatment.	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.

Secondary Outcome Measures

Name	Time	Method
Discontinuation of antibiotic treatment due to the antibiotic - diarrhoea.	Up to 10 days after initiation of antibiotic treatment.
Intravenous rehydration due to the antibiotic-associated diarrhea	Up to 24 days after initiation of antibiotic treatment.

Trial Locations

Locations (1)

Medical University of Warsaw's Department of Paediatric Gastroenterology and Nutrition; 🇵🇱 Warsaw, Mazovia, Poland