Clinical trial NCT02626104: Bovine Lactoferrin and Antibiotic-associated Diarrhoea.
Official title: Bovine Lactoferrin in the Prevention of Antibiotic-associated Diarrhoea in Children - a Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Antibiotic Associated Diarrhoea
Keywords: lactoferrin
clostridium difficile
antibiotic associated diarrhoea
children
antibiotic therapy
diarrhoea
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
Collaborators: name: Pharmabest Sp. z o.o.
First posted: 2015-12-10
Enrollment: 156
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Occurence of antibiotic-associated diarrhoea.
timeFrame: Up to 24 days after initiation of antibiotic treatment.
Secondary outcomes:
measure: Discontinuation of antibiotic treatment due to the antibiotic - diarrhoea.
timeFrame: Up to 10 days after initiation of antibiotic treatment.
measure: Intravenous rehydration due to the antibiotic-associated diarrhea
timeFrame: Up to 24 days after initiation of antibiotic treatment.
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Medical University of Warsaw's Department of Paediatric Gastroenterology and Nutrition
state: Mazovia
Study officials:
affiliation: Department of Paediatric Gastroenterology and Nutrition
name: Piotr Albrecht, Ph.D.
role: STUDY_CHAIR
References:
citation: Wronowski MF, Kotowska M, Banasiuk M, Kotowski A, Kuzmicka W, Albrecht P. Bovine Lactoferrin in the Prevention of Antibiotic-Associated Diarrhea in Children: A Randomized Clinical Trial. Front Pediatr. 2021 Jun 7;9:675606. doi: 10.3389/fped.2021.675606. eCollection 2021.