A Non-inferiority, Multicenter and Randomized, Single-Dose Study About a Treatment to Hypolactasia (LAILAI)

Study Overview
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Brief Summary
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The study primary objective is to compare the clinical efficacy of two formulations in the supportive treatment of lactose intolerance.

Official Title
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A Phase III, Non-Inferiority, Randomized, Double-Blind, Parallel-Group, Multicentre, Single-Dose, Comparative Clinical Study of Lactase Eurofarma (Test Drug) and Lactaid® (Comparative Drug), Assessing the Efficacy and Safety in the Treatment of Patients With Lactose Intolerance (Hypolactasia)

Conditions
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Hypolactasia

Intervention / Treatment
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* Drug: Lactase


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient should be a male or female, aged between 18 and 60 years old; Have a medical history consistent with lactose intolerance, confirmed by the test of hydrogen in the expired air; The female patients should agree to use birth control methods during the study participation; To be able to meet the study instructions and all the visits required; To give a free consent to participate in the study and sign the informed consent form (ICF). Exclusion Criteria: Smoking; Secondary hypolactasia; Gastrointestinal inflammatories diseases - present diverticular disease, diabetic gastropathy or neoplasias; Colonoscopy or colon cleaning procedure 4 weeks before the start of study Latrogenic: unnoticed intake of laxatives in over-the-counter drugs or alternative medicine, intake of cereal bran or probiotics; Diagnosis of HIV, immunodepression of any origin, or cancer under treatment. Diagnosis of other comorbidity that, at the investigator's discretion, may compromise the study participation (e.g., systemic infection during the study or use of antibiotics in the last 4 weeks, diabetes mellitus, uncontrolled hypertension or renal failure), Hypersensitivity or previous laboratory or clinical adverse event related to the use of lactase or any of the components of the formulations used in the study; Incapacity to understand and complete the study questionnaires, including the questions that require the use of the Visual Analogue Scale and ICF; Pregnancy or lactation; Use of alcohol, exceeding 3 doses daily; Participation in another clinical study on the last 12 months; Patient having some chronic pulmonary disease that, in the investigator's opinion, may harm or interfere with the expired hydrogen test (e.g., cystic fibrosis).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lactase EUF<br>1 chewable tablet of the test drug 30 minutes before the standard lactose dose (25 g). | Drug: Lactase<br>* 1 chewable tablet of the test drug or comparative drug 30 minutes before the standard lactose dose (25 g).<br>|
| Active Comparator: Lactase Ref<br>1 chewable tablet of the comparative drug 30 minutes before the standard lactose dose (25 g). | Drug: Lactase<br>* 1 chewable tablet of the test drug or comparative drug 30 minutes before the standard lactose dose (25 g).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |