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Bovine Lactoferrin and Antibiotic-associated Diarrhoea. (BLAAD)

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ClinicalTrials.gov Identifier: NCT02626104
Recruitment Status : Completed
First Posted : December 10, 2015
Last Update Posted : June 15, 2018
Sponsor:
Collaborator:
Pharmabest Sp. z o.o.
Information provided by (Responsible Party):
Medical University of Warsaw

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.

Condition or disease Intervention/treatment Phase
Antibiotic Associated Diarrhoea Dietary Supplement: Bovine lactoferrin Dietary Supplement: Maltodextrin Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 156 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Bovine Lactoferrin in the Prevention of Antibiotic-associated Diarrhoea in Children - a Randomized Clinical Trial.
Actual Study Start Date : December 2015
Actual Primary Completion Date : March 1, 2017
Actual Study Completion Date : March 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Diarrhea

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.




Primary Outcome Measures :
  1. Occurence of antibiotic-associated diarrhoea. [ Time Frame: 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 Outcome Measures :
  1. Discontinuation of antibiotic treatment due to the antibiotic - diarrhoea. [ Time Frame: Up to 10 days after initiation of antibiotic treatment. ]
  2. Intravenous rehydration due to the antibiotic-associated diarrhea [ Time Frame: Up to 24 days after initiation of antibiotic treatment. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02626104


Locations
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Poland
Medical University of Warsaw's Department of Paediatric Gastroenterology and Nutrition
Warsaw, Mazovia, Poland, 01-184
Sponsors and Collaborators
Medical University of Warsaw
Pharmabest Sp. z o.o.
Investigators
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Study Chair: Piotr Albrecht, Ph.D. Department of Paediatric Gastroenterology and Nutrition

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Responsible Party: Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT02626104     History of Changes
Other Study ID Numbers: BLAAD
First Posted: December 10, 2015    Key Record Dates
Last Update Posted: June 15, 2018
Last Verified: November 2015
Keywords provided by Medical University of Warsaw:
lactoferrin
clostridium difficile
antibiotic associated diarrhoea
children
antibiotic therapy
diarrhoea
Additional relevant MeSH terms:
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Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Anti-Bacterial Agents
Antibiotics, Antitubercular
Lactoferrin
Anti-Infective Agents
Antitubercular Agents