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 @ 2:17 AM
Ignite Modification Date:
2025-12-25 @ 2:17 AM
NCT ID:
NCT02349360
Eligibility Criteria:
Inclusion Criteria:
* To participate in the study individuals must
* be 18-50 years old.
* be willing to complete multiple questionnaires via computer.
* be willing to take the probiotic or placebo capsule daily for 8 weeks.
* be willing to provide 1 stool during weeks 0, 2, 4, 8 and 12 of the study.
* be willing to provide blood samples at weeks -1, 0, 2, 4, 8 and 12 of the study.
* have daily access to a computer with internet access for the entire 13-wk study.
* be willing to provide a social security number
Exclusion Criteria:
* To participate in the study individuals must NOT
* currently take medications for constipation, diarrhea or psychological disorders (depression, anxiety, insomnia etc.).
* have taken antibiotics within the past four weeks prior to randomization.
* currently take probiotic supplements and do not want to discontinue a minimum of two weeks prior to the study
* have had or are currently being treated for any diseases or illnesses such as gastrointestinal disease (gastric ulcers, Crohn's, ulcerative colitis, etc.), chronic disease like diabetes or kidney disease, immune-compromising diseases or conditions (HIV, AIDS, hepatitis, cancer, transplant patient etc.)
* currently receive medical treatment for stress induced symptoms/disorders
* be a current smoker
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT02349360
Study Brief:
Protocol Section:
NCT02349360