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 @ 1:08 AM
Ignite Modification Date:
2025-12-25 @ 1:08 AM
NCT ID:
NCT05820893
Eligibility Criteria:
Inclusion Criteria:
1. Ability to provide informed written consent
2. Willing to comply with all study procedures and be available for the duration of the study.
3. Ability to take oral medication.
4. Willing to provide blood and stool samples
5. Meeting the modified Kansas GWI case definition\* with gut symptoms endorsed
6. Aged 45-80 years old
* Moderate to severe GWI symptoms lasting at least 6 months in a minimum of three of the six symptom domains (one of which must be fatigue). The symptom domains are:
* Pain (joint pain, muscle pain)
* Gastrointestinal (diarrhea, nausea, vomiting, cramping)
* Respiratory (persistent cough, wheezing)
* Skin (rashes)
* Fatigue (sleep problems, fatigue)
* Neurologic (memory problems, headaches, dizziness, mood changes)
Exclusion Criteria:
1. A Known SARS-CoV-2 infection in the last 60 days and/or with a diagnosis of post-acute sequelae of COVID-19 (PASC, sometimes called long COVID) defined as COVID-19 symptoms lasting for greater than 6 months.
2. Subjects identified as, or appearing to, lack consent capacity
3. Current smokers
4. Alcohol abuse (greater than 14 drinks per week for men and 7 drinks per week for women)
5. Use of investigational drugs, biologics, or devices within 30 days prior to randomization.
6. Individuals who are pregnant, lactating or planning on becoming pregnant during the study.
7. Diagnosed inflammatory bowel disease, Crohn's disease, or Celiac's disease
8. Hypothyroidism
9. Unstable psychiatric illness
10. Involvement in another clinical trial
11. Previous gastrointestinal surgery (colorectal surgery, gastric bypass, intestinal resection)
12. Use of other prebiotics, probiotics (including yogurt containing live probiotics), postbiotics, or other fiber supplements in the last 30 days
13. Systemic antibiotics in the last 30 days
14. Fecal microbiota transplant in the last 30 days
15. Active dysphagia
16. Allergies to any of the ingredients in MSPrebiotic
17. Individuals with a Kansas criteria exclusionary condition: lupus, multiple sclerosis, schizophrenia, active cancer treatment, physical impairment related to a stroke, uncontrolled Diabetes Mellitus
18. Use of anti-diarrheal agents, stool softeners, or immunomodulatory medications in the last 30 days.
19. The use of proton pump inhibitors, H2 receptor blockers or any other medication known to suppress gastric acid in the last 30 days.
20. Any other factor, condition, or medication not listed above the Investigators believe will affect the response in the gut or the interpretation of results.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
80 Years
Study:
NCT05820893
Study Brief:
Protocol Section:
NCT05820893