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:
2025-12-26 @ 3:58 PM
Ignite Modification Date:
2025-12-26 @ 3:58 PM
NCT ID:
NCT06620406
Eligibility Criteria:
Inclusion Criteria:
1. \>18 years of age,
2. Prior mild acute SARS-CoV-2 infection (positive testing by FDA approved antigen or molecular test or positive anti-nucleocapsid antibody) and not requiring hospitalization
3. Meeting Center for Disease Control (CDC) criteria for PASC (any new or recurrent symptom present \>4 weeks after SARS-COV-2 infection)
4. Meeting 2015 Institute of Medicine (IOM) criteria for myalgic encephalomyelitis/chronic fatigue syndrome (ME-CFS) of 3 required symptoms for fatigue to select for individuals specifically with NP-PASC (a substantial reduction or impairment in ability to engage in pre-illness levels of activity, post-exertional malaise, and unrefreshing sleep) and at least one of the two following manifestations (cognitive impairment or orthostatic intolerance).
5. meets cognitive impairment threshold on neurocognitive battery.
Exclusion Criteria:
1. Pregnancy or breastfeeding
2. Currently taking or using the following non-study products within 30 days prior to study entry:
* probiotics, prebiotics, or fiber supplements
* immunosuppressive or immunomodulatory drugs
* antibiotics
3. Heavy drug or alcohol use
4. Known allergy to any of the study products
5. Serious illness requiring systemic treatment and/or hospitalization within 30 prior to study entry
6. Liver cirrhosis, history of inflammatory bowel disease, or other major conditions related to colon
7. Any episode of acute or persistent diarrhea within 1 day prior to study entry
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06620406
Study Brief:
Protocol Section:
NCT06620406