Bovine Lactoferrin and Antibiotic-associated Diarrhoea. (BLAAD)

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

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.

Study Overview

• Status: Completed
• Conditions: Antibiotic Associated Diarrhoea
• Intervention / Treatment: Dietary supplement: Bovine lactoferrin; Dietary supplement: Maltodextrin

• Study Type: Interventional
• Enrollment (Actual): 156
• Phase: Phase 2

Contacts and Locations

Study Locations

• Poland
  • Mazovia
    • Warsaw, Mazovia, Poland, 01-184
      • Medical University of Warsaw's Department of Paediatric Gastroenterology and Nutrition

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A - Lactoferrin; Bovine lactoferrin orally - 100 mg twice a day, for whole antibiotic treatment period.	Dietary supplement: 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.
Placebo Comparator: B - Maltodextrin; Maltodextrin orally - 100 mg twice a day, for whole antibiotic treatment period.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurence of antibiotic-associated diarrhoea.	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.	Up to 24 days after initiation of antibiotic treatment.

Secondary Outcome Measures

Outcome 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.

Collaborators and Investigators

• Sponsor: Medical University of Warsaw
• Collaborators: Pharmabest Sp. z o.o.
• Investigators: Study Chair: Piotr Albrecht, Ph.D., Department of Paediatric Gastroenterology and Nutrition

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2015
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: June 29, 2015
• First Submitted That Met QC Criteria: December 9, 2015
• First Posted (Estimate): December 10, 2015

Study Record Updates

• Last Update Posted (Actual): June 15, 2018
• Last Update Submitted That Met QC Criteria: June 14, 2018
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: children; diarrhoea; lactoferrin; antibiotic therapy; antibiotic associated diarrhoea; clostridium difficile
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Diarrhea; Anti-Infective Agents; Lactoferrin
• Other Study ID Numbers: BLAAD