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 @ 1:50 PM
Ignite Modification Date:
2025-12-24 @ 1:50 PM
NCT ID:
NCT05045495
Eligibility Criteria:
Inclusion Criteria:
* Subject must provide informed consent prior to any study procedures being performed.
* Subject is a U.S. resident, and speaks and understands English
* Subject is male or female, ≥ 18 years old.
* CSID Cases must have been on Sucraid for at the last 12 months.
* Healthy Volunteers do not have a CSID diagnosis or other chronic gastrointestinal conditions.
* Subject must have their own Android or Apple device to access the mobile patient app.
Exclusion Criteria:
* Females who are lactating or pregnant.
* Subjects with allergy to sucrose.
* Subjects with causes of abdominal pain or altered bowel habits other than symptoms -related to CSID (in CSID group) such as SIBO, IBD, celiac disease, pancreatitis, or -gastrointestinal bleeding.
* Diabetes mellitus.
* Use of systemic antibiotics, had a barium study, colonoscopy, unexplained runny diarrhea, or similar within 14 days prior to informed consent. Potential subjects can be re-screened once they meet this criterion.
* Recent febrile illness.
* Subject has major physical or psychiatric illness within the last 6 months that in the opinion of the investigator would affect the subject's ability to complete the trial.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05045495
Study Brief:
Protocol Section:
NCT05045495