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Bovine Lactoferrin and Antibiotic-associated Diarrhoea. (BLAAD)

Primary Purpose

Antibiotic Associated Diarrhoea

Status
Completed
Phase
Phase 2
Locations
Poland
Study Type
Interventional
Intervention
Bovine lactoferrin
Maltodextrin
Sponsored by
Medical University of Warsaw
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Antibiotic Associated Diarrhoea focused on measuring lactoferrin, clostridium difficile, antibiotic associated diarrhoea, children, antibiotic therapy, diarrhoea

Eligibility Criteria

1 Year - 18 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

A - Lactoferrin

B - Maltodextrin

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Discontinuation of antibiotic treatment due to the antibiotic - diarrhoea.
Intravenous rehydration due to the antibiotic-associated diarrhea

Full Information

First Posted
June 29, 2015
Last Updated
June 14, 2018
Sponsor
Medical University of Warsaw
Collaborators
Pharmabest Sp. z o.o.
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1. Study Identification

Unique Protocol Identification Number
NCT02626104
Brief Title
Bovine Lactoferrin and Antibiotic-associated Diarrhoea.
Acronym
BLAAD
Official Title
Bovine Lactoferrin in the Prevention of Antibiotic-associated Diarrhoea in Children - a Randomized Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
December 2015 (Actual)
Primary Completion Date
March 1, 2017 (Actual)
Study Completion Date
March 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Warsaw
Collaborators
Pharmabest Sp. z o.o.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Antibiotic Associated Diarrhoea
Keywords
lactoferrin, clostridium difficile, antibiotic associated diarrhoea, children, antibiotic therapy, diarrhoea

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
156 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A - Lactoferrin
Arm Type
Experimental
Arm Description
Bovine lactoferrin orally - 100 mg twice a day, for whole antibiotic treatment period.
Arm Title
B - Maltodextrin
Arm Type
Placebo Comparator
Arm Description
Maltodextrin orally - 100 mg twice a day, for whole antibiotic treatment period.
Intervention Type
Dietary Supplement
Intervention Name(s)
Bovine lactoferrin
Intervention Description
The children will be randomly assigned to receive 100 mg of bovine lactoferrin twice a day orally for the whole period of antibiotic therapy.
Intervention Type
Dietary Supplement
Intervention Name(s)
Maltodextrin
Intervention Description
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 Outcome Measure Information:
Title
Occurence of antibiotic-associated diarrhoea.
Description
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.
Time Frame
Up to 24 days after initiation of antibiotic treatment.
Secondary Outcome Measure Information:
Title
Discontinuation of antibiotic treatment due to the antibiotic - diarrhoea.
Time Frame
Up to 10 days after initiation of antibiotic treatment.
Title
Intravenous rehydration due to the antibiotic-associated diarrhea
Time Frame
Up to 24 days after initiation of antibiotic treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Piotr Albrecht, Ph.D.
Organizational Affiliation
Department of Paediatric Gastroenterology and Nutrition
Official's Role
Study Chair
Facility Information:
Facility Name
Medical University of Warsaw's Department of Paediatric Gastroenterology and Nutrition
City
Warsaw
State/Province
Mazovia
ZIP/Postal Code
01-184
Country
Poland

12. IPD Sharing Statement

Citations:
PubMed Identifier
34164360
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.
Results Reference
derived

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Bovine Lactoferrin and Antibiotic-associated Diarrhoea.

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