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:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07377994
Eligibility Criteria:
Inclusion Criteria:
1. Male or female, aged between 18 and 50 years.
2. Female participants are either not of childbearing potential, or females of childbearing potential agree to use a medically approved method of birth control and have a negative urine pregnancy test result.
3. In good general health, as determined by medical history, laboratory analysis, and physical examination performed by the study physician.
4. Willing to provide fecal samples as per the study requirements.
5. Willing to participate voluntarily and provide written informed consent.
Exclusion Criteria:
1. Women who are pregnant or lactating.
2. Subjects who are taking Antibiotic treatment.
3. Subjects suffering from Gastrointestinal disease.
4. Subjects suffering from Diabetes.
5. Subjects suffering from Chronic/iatrogenic Immunodeficiency.
6. Subjects suffering from Abnormal blood pressure.
7. Subjects who are allergic to ingredients of the study Product.
8. Subjects who are Smoker or alcoholic.
9. Subjects who have participated prior in conflicting clinical trial or have participated in the trial over the last 3months.
10. Women who are pregnant, breastfeeding, or planning to become pregnant.
11. Daily use of supplements that contain probiotics or prebiotics within 30 days prior to screening or during study.
12. Subjects with medical conditions affecting immune status (e.g., rheumatoid arthritis, heart failure, hepatitis C, HIV) or taking medications that may impact the immune system, such as antibiotics, antimicrobials, or probiotic sachets.
13. Any surgical treatment within the previous three months or planned during the study.
14. Any subject, in the principal investigator's opinion, not considered suitable for enrolment.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT07377994
Study Brief:
Protocol Section:
NCT07377994