Skip to main content
OpenTrials
Completed

NCT Number: NCT02626104

Bovine Lactoferrin and Antibiotic-associated Diarrhoea.

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Antibiotic Associated Diarrhoea Diarrhea Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Medical University of Warsaw's Department of Paediatric Gastroenterology and Nutrition

Warsaw, Masovian Voivodeship, 01-184, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bovine Lactoferrin

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.

Maltodextrin

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.

Primary outcomes

  1. Occurence of antibiotic-associated diarrhoea.

    Time frame: 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 outcomes

  1. Discontinuation of antibiotic treatment due to the antibiotic - diarrhoea.

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

  2. Intravenous rehydration due to the antibiotic-associated diarrhea

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

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Collaborators

  • Pharmabest Sp. z o.o.

Registry information

Official study title

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

Acronym: BLAAD

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 10, 2015
Registry last updated
Jun 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.