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:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2025-12-24 @ 11:19 PM
NCT ID:
NCT07239856
Eligibility Criteria:
Inclusion Criteria:
* Individuals who report being intolerant to cow milk but not to goat milk (one group) or tolerant to both cow milk and goat milk (another group)
* Good general health (WHO grade = 0)
* Affiliated with a social security scheme
* Free, informed, and express consent, in accordance with the public health code: 'No research mentioned in 2° of Article L. 1121-1 can be conducted on a person without their free, informed, and express consent.
Exclusion Criteria:
* Individuals under guardianship or curatorship
* Individuals under legal protection
* Any known food allergies
* Anemia: hemoglobin levels below 13 g/dL for men and 12 g/dL for women
* Pregnant women or those likely to be (based on a positive urine pregnancy test at the time of inclusion)
* Excessive alcohol consumption (\>2 drinks/day). Harmful alcohol consumption is assessed by the investigator at the time of inclusion.
* Hypertension, diabetes, digestive tract diseases (except for irritable bowel syndrome, IBS), liver or kidney diseases, severe heart disease. The presence of these conditions will be assessed by the investigator based on usual clinical criteria and the volunteers' declarations during inclusion. Hypertension: Significant arterial hypertension as determined by the investigator or systolic blood pressure greater than or equal to 140 mmHg and/or diastolic blood pressure greater than or equal to 90 mmHg on the day of inclusion. Diabetes: Type 1 or Type 2 diabetes or any fasting blood glucose level \> 1.25 g/l. Digestive tract disease: Gastrointestinal disorders deemed by the investigator as clinically significant (bleeding, vomiting, constipation/diarrhea grade \>1), any inflammatory bowel disease, acute gastroenteritis in the month preceding the intervention. Liver disease: Any significant liver disorder as determined by the investigator or any AST/ALT \> 2.5 times the upper normal limit.
* Elite athletes (\> 8 hours per week)
* Blood donation in the 3 months preceding the start of the study
* Participation in a clinical study in the 3 months preceding the study
* Lack of free, informed, and express consent
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07239856
Study Brief:
Protocol Section:
NCT07239856