Bovine Lactoferrin and Antibiotic-associated Diarrhoea.

Antibiotic Associated Diarrhoea Clinical Trial

— BLAAD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02626104
• Other study ID #: BLAAD
• Status: Completed
• Phase: Phase 2
• Start date: December 2015
• Est. completion date: March 1, 2017

Study information

• Verified date: November 2015
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: March 1, 2017
• Est. primary completion date: March 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Antibiotic Associated Diarrhoea
• Diarrhea

Intervention

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.
• 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.

Locations

Country	Name	City	State
Poland	Medical University of Warsaw's Department of Paediatric Gastroenterology and Nutrition	Warsaw	Mazovia

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Warsaw	Pharmabest Sp. z o.o.

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Discontinuation of antibiotic treatment due to the antibiotic - diarrhoea.		Up to 10 days after initiation of antibiotic treatment.
Secondary	Intravenous rehydration due to the antibiotic-associated diarrhea		Up to 24 days after initiation of antibiotic treatment.