Bovine Lactoferrin and Antibiotic-associated Diarrhoea.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2017-03-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Antibiotic Associated Diarrhoea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A - Lactoferrin

Bovine lactoferrin orally - 100 mg twice a day, for whole antibiotic treatment period.

Group Type EXPERIMENTAL

Bovine lactoferrin

Intervention Type DIETARY_SUPPLEMENT

The children will be randomly assigned to receive 100 mg of bovine lactoferrin twice a day orally for the whole period of antibiotic therapy.

B - Maltodextrin

Maltodextrin orally - 100 mg twice a day, for whole antibiotic treatment period.

Group Type PLACEBO_COMPARATOR

Maltodextrin

Intervention Type DIETARY_SUPPLEMENT

The children will be randomly assigned to receive 100 mg of placebo - maltodextrin twice a day orally for the whole period of antibiotic therapy.

Interventions

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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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No