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

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).