Bovine Lactoferrin and Antibiotic-associated Diarrhoea.

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02626104

Acronym

BLAAD

Enrollment

156

Registered

2015-12-10

Start date

2015-12-31

Completion date

2017-03-01

Last updated

2018-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antibiotic Associated Diarrhoea

Keywords

lactoferrin, clostridium difficile, antibiotic associated diarrhoea, children, antibiotic therapy, diarrhoea

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.

Interventions

DIETARY_SUPPLEMENTBovine 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.

DIETARY_SUPPLEMENTMaltodextrin

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

1 Years to 18 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
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.

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026