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:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2025-12-24 @ 3:06 PM
NCT ID:
NCT07017959
Eligibility Criteria:
Inclusion Criteria:
1. Age 18 years or older.
2. Individuals with a confirmed diagnosis of IBD, including:
* History of IBD for more than 3 months
* Last colonoscopy within 2 years of study entry
* Mild to moderate IBD symptoms
3. Participants who can provide informed consent with a signature.
4. Body mass index (BMI) between 18 and 40 kg/m²
5. English Speaking
Exclusion Criteria:
Participants meeting any of the following criteria will be excluded:
1. History of severe GI surgery.
2. History of antibiotics, diarrhea, or vomiting within the past 30 days.
3. Use of intravenous corticosteroids within 2 weeks before screening, during screen-ing, or during the study period.
4. Diagnosis with cancer and/or going through chemotherapy/radiation therapy within the past 2 years.
5. Dramatic weight change (\>20 pounds) in the past 2 weeks.
6. Using other microbiome-influencing drugs or interventions.
7. Participating in another clinical trial.
11\. Ongoing use of non-study probiotics, prebiotics, synbiotics and postbiotics. They can be readmitted if stop such regimens for minimum 30 days.
11.1 Probiotic use is defined as consumption of ≥108 CFU/day, in the form of tablets, capsules, lozenges, powders, or dairy products in which probiot-ics are a major ingredient 12. Heavily consuming (\>2 servings per day) yogurt, kefir, kombucha and other fermented food products that can influence microbiome.
13\. If they have heart disease, renal disease, active infection, gum bleeding disorder, severe diabetes, obesity (\>40 BMI), immunodeficiency, or thyroid disorders.
14\. History of anaphylaxis or allergies to probiotics or postbiotics. 15. Uncooperative behavior or any condition that could make the participant potentially non-compliant with the study procedures.
16\. Any individuals classified in one of the vulnerable populations, including pregnant women, neonates, prisoners, and children
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07017959
Study Brief:
Protocol Section:
NCT07017959