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:
NCT07462494
Eligibility Criteria:
Inclusion Criteria:
1. Aged 18-65 years.
2. Patients with constipation, defined as fewer than three bowel movements per week and/or Bristol Stool Form Scale (BSFS) types 1-2.
3. Able to comply with the study protocol and complete the study procedures.
4. Participants who have voluntarily signed the informed consent form.
5. Participants (including male participants) must have no plans for pregnancy from 14 days before screening until 6 months after the end of the study and must agree to use effective contraception during this period.
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Exclusion Criteria:
1. Individuals who have recently taken products with similar functions to the investigational product that may affect the evaluation of study outcomes.
2. Participants who plan to change their dietary habits during the study period.
3. Patients with severe allergies or immunodeficiency.
4. Women who are pregnant, breastfeeding, or planning to become pregnant.
5. Patients with severe diseases of major organs such as the cardiovascular system, lungs, liver, or kidneys, or those with severe metabolic diseases (e.g., diabetes or thyroid disorders), malignant tumors, or severe immune system diseases.
6. Individuals who have used antibiotics within the past two weeks.
7. Individuals with severe psychological or psychiatric disorders.
8. Participants who fail to take the investigational product as required or fail to attend scheduled follow-up visits, resulting in an inability to determine treatment efficacy.
9. Any other participants considered unsuitable for participation in the study by the investigator.
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Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07462494
Study Brief:
Protocol Section:
NCT07462494