Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-25 @ 1:47 AM
NCT ID:
NCT04164394
Eligibility Criteria:
Inclusion Criteria:
* Subjects attending Hospital Juarez de Mexico with self-reported lactose intolerance, a minimum lactose intolerance symptom score of 6 points, 20ppm during the Lactose Hydrogen Breath Test (LHBT) and providing Informed Consent.
Exclusion Criteria:
* More than 10 ppm before ingestion of lactose in the Lactose Hydrogen Breath Test (LHBT). If such value was observed, the LHBT test was repeated on a 2nd day, and if \>10ppm persisted, patient was excluded.
* BMI below 18 or above 40
* Subjects not accepting to maintain their dietary and physical activity pattern unchanged for the duration of the study
* Subjects with congenital lactase deficiency
* Pregnant or lactating women
* Significant gastrointestinal disease, such as inflammatory bowel disease, coeliac disease, chronic diarrhea or gastroparesis
* History of gastrointestinal surgery in the 6 months prior to inclusion
* History of intestinal perforation
* History of acute gastroenteritis, acute gastroenteritis or hospitalization in the 4 weeks prior to inclusion
* Substance abuse
* Untreated thyroid disorder
* Cancer
* Other severe diseases that in the doctor's opinion could interfere with the study
* Known allergy to any of the components in the treatments
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT04164394
Study Brief:
Protocol Section:
NCT04164394