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 @ 9:44 PM
Ignite Modification Date:
2025-12-24 @ 9:44 PM
NCT ID:
NCT06964932
Eligibility Criteria:
Inclusion Criteria:
1. A body mass index (BMI) of 25 kg/m² or above;
2. Voluntarily signing an informed consent form to take part in the study;
3. Willingness to undertake the study protocol and associated restrictions, such as adhering to a calorie - restricted - low carbohydrate diet;
4. No intention to become pregnant from 14 days before screening, and commitment to using effective contraception until six months after the trial concludes.
Exclusion Criteria:
1. Intake of products akin to the test product in the recent period that might sway the outcomes;
2. Presence of mental or neurological disorders, celiac disease, lactose intolerance, or allergic conditions;
3. Being pregnant, breastfeeding, or planning to conceive;
4. Past diagnosis of Irritable Bowel Syndrome, Ulcerative Colitis, Hepatic Cirrhosis, or Diabetes Mellitus;
5. Use of antibiotics in the preceding three months;
6. Inability to comply with the test product regimen or attend follow-up visits regularly, making efficacy assessment unfeasible;
7. Smoking in excess of 10 cigarettes daily;
8. Hypersensitivity to probiotic products;
9. Any other participants deemed unsuitable for the research by the investigator.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06964932
Study Brief:
Protocol Section:
NCT06964932