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| Name | Class |
|---|---|
| Pharmabest Sp. z o.o. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A - Lactoferrin | Experimental | Bovine lactoferrin orally - 100 mg twice a day, for whole antibiotic treatment period. |
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| B - Maltodextrin | Placebo Comparator | Maltodextrin orally - 100 mg twice a day, for whole antibiotic treatment period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bovine lactoferrin | Dietary Supplement | The children will be randomly assigned to receive 100 mg of bovine lactoferrin twice a day orally for the whole period of antibiotic therapy. |
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Piotr Albrecht, Ph.D. | Department of Paediatric Gastroenterology and Nutrition | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Warsaw's Department of Paediatric Gastroenterology and Nutrition | Warsaw | Masovian Voivodeship | 01-184 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34164360 | Derived | 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. |
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| ID | Term |
|---|---|
| D003967 | Diarrhea |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C008315 | maltodextrin |
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| Maltodextrin | Dietary Supplement | The children will be randomly assigned to receive 100 mg of placebo - maltodextrin twice a day orally for the whole period of antibiotic therapy. |
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