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 @ 9:49 PM
Ignite Modification Date:
2025-12-24 @ 9:49 PM
NCT ID:
NCT07089732
Eligibility Criteria:
Inclusion Criteria:
* Adults aged 18 to 70 years.
* Clinically diagnosed with prediabetes (fasting plasma glucose: 100-125 mg/dL or HbA1c: 5.7-6.4%) or with a body mass index (BMI) of 25-34.9 kg/m², male or female.
* Have not participated in similar clinical studies within the past three months.
* Able to comprehend the informed consent form, including the study procedures, potential risks, and benefits, and able to provide written informed consent.
Exclusion Criteria:
* Diagnosed with autoimmune diseases or cancer.
* Diagnosed with gastrointestinal chronic diseases such as irritable bowel syndrome, inflammatory bowel disease, Crohn's disease, celiac disease, bowel control disorders, fecal incontinence, pancreatitis, peptic ulcer disease, colorectal cancer, short bowel syndrome, ulcerative colitis, lactose intolerance, or chronic diarrhea.
* History of gastrointestinal surgery.
* Planning pregnancy in the near future (including male partners), currently pregnant, or breastfeeding women.
* Known allergy or hypersensitivity to probiotics or any of the study product ingredients.
* History of major psychiatric disorders.
* History of substance abuse or alcohol dependency.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT07089732
Study Brief:
Protocol Section:
NCT07089732