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
|Condition or disease||Intervention/treatment||Phase|
|Antibiotic Associated Diarrhoea||Dietary Supplement: Bovine lactoferrin Dietary Supplement: Maltodextrin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||156 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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.
- 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.
- Discontinuation of antibiotic treatment due to the antibiotic - diarrhoea. [ Time Frame: Up to 10 days after initiation of antibiotic treatment. ]
- Intravenous rehydration due to the antibiotic-associated diarrhea [ Time Frame: Up to 24 days after initiation of antibiotic treatment. ]
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
|Medical University of Warsaw's Department of Paediatric Gastroenterology and Nutrition|
|Warsaw, Mazovia, Poland, 01-184|
|Study Chair:||Piotr Albrecht, Ph.D.||Department of Paediatric Gastroenterology and Nutrition|