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The study primary objective is to compare the clinical efficacy of two formulations in the supportive treatment of lactose intolerance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lactase EUF | Experimental | 1 chewable tablet of the test drug 30 minutes before the standard lactose dose (25 g). |
|
| Lactase Ref | Active Comparator | 1 chewable tablet of the comparative drug 30 minutes before the standard lactose dose (25 g). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactase | Drug | 1 chewable tablet of the test drug or comparative drug 30 minutes before the standard lactose dose (25 g). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hydrogen value in the air expired | Hydrogen value in the expired air for 3h after the patient exposure to the standardized Lactose 25g dose with interventional exogenous Lactase (comparative and test drugs). | 03 times |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aderson Damião, M.D | Hospital das Clínicas de São Paulo | Principal Investigator |
| Heda Amarante, M.D | Hospital Nossa Senhora das Graças | Principal Investigator |
| Marta Machado, M.D | Hospital São Lucas PUCRS | Principal Investigator |
| Sender Miszputen, M.D | Hospital São Paulo / UNIFESP | Principal Investigator |
| Wilson Catapani, M.D | Faculdade de Medicina do ABC | Principal Investigator |
| Mauro Bafutto, M.D | Instituto Goiano de Gastroenterologia | Principal Investigator |
| Carlos Francesconi, M.D | Hospital Mãe de Deus | Principal Investigator |
| Maria do Carmo Passos, M.D | Instituto Alfa de Gastroenterologia de BH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Goiano de Gastroenterologia | Goiânia | Goiás | Brazil | |||
| Instituto Alfa de Gastroenterologia |
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| ID | Term |
|---|---|
| D007787 | Lactose Intolerance |
| ID | Term |
|---|---|
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D043322 | Lactase |
| ID | Term |
|---|---|
| D001616 | beta-Galactosidase |
| D005696 | Galactosidases |
| D006026 | Glycoside Hydrolases |
| D006867 | Hydrolases |
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| Belo Horizonte |
| Minas Gerais |
| Brazil |
| Hospital Nossa Senhora das Graças | Curitiba | Paraná | Brazil |
| Hospital São Lucas | Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Hospital Mãe de Deus | Porto Alegre | Rio Grande do Sul | Brazil |
| Faculdade de Medicina do ABC | Santo André | São Paulo | Brazil |
| Hospital São Paulo / UNIFESP | São Paulo | São Paulo | Brazil |
| D002239 | Carbohydrate Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004798 |
| Enzymes |
| D045762 | Enzymes and Coenzymes |