Bovine Lactoferrin and Antibiotic-associated Diarrhoea.

NCT02626104 | Completed Phase 2

• 1 other identifier: BLAAD
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

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.

Conditions

Antibiotic Associated Diarrhoea

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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.

Study Arms (2)

A - Lactoferrin

EXPERIMENTAL

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

Dietary Supplement: Bovine lactoferrin

B - Maltodextrin

PLACEBO COMPARATOR

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

Dietary Supplement: Maltodextrin

Interventions

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.

A - Lactoferrin

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.

B - Maltodextrin

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Warsaw: lead
• Pharmabest Sp. z o.o.: collaborator

Study Sites (1)

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

Warsaw, Masovian Voivodeship, 01-184, Poland

Location

Related Publications (1)

• 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.

  PMID: 34164360 DERIVED

MeSH Terms

Conditions

Diarrhea

Interventions

maltodextrin

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Piotr Albrecht, Ph.D.

  Department of Paediatric Gastroenterology and Nutrition

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2015
• First Posted: December 10, 2015
• Study Start: December 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: June 15, 2018

Record last verified: 2015-11

Locations

PL (1)