Bovine Lactoferrin and Antibiotic-associated Diarrhoea.

Study Overview
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Brief Summary
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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.

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

Conditions
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Antibiotic Associated Diarrhoea

Intervention / Treatment
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* Dietary Supplement: Bovine lactoferrin
* Dietary Supplement: Maltodextrin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A - Lactoferrin<br>Bovine lactoferrin orally - 100 mg twice a day, for whole antibiotic treatment period. | Dietary Supplement: Bovine lactoferrin<br>* The children will be randomly assigned to receive 100 mg of bovine lactoferrin twice a day orally for the whole period of antibiotic therapy.<br>|
| Placebo Comparator: B - Maltodextrin<br>Maltodextrin orally - 100 mg twice a day, for whole antibiotic treatment period. | Dietary Supplement: Maltodextrin<br>* The children will be randomly assigned to receive 100 mg of placebo - maltodextrin twice a day orally for the whole period of antibiotic therapy.<br>|

What is the study measuring?
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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 | Measure Description | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lactoferrin, clostridium difficile, antibiotic associated diarrhoea, children, antibiotic therapy, diarrhoea