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 @ 12:56 PM
Ignite Modification Date:
2025-12-24 @ 12:56 PM
NCT ID:
NCT05480761
Eligibility Criteria:
Inclusion Criteria:
* Subjects with documented disaccharidase assay levels of lactase, sucrase, maltase, and palatinase via EGD disaccharidase assay (DA) performed no more than 1 year prior to enrollment with normal histological interpretation. Eligible subjects will be enrolled into the following study groups based on their documented sucrase level.
* DA Sucrase \< 25 (n=500)
* DA Sucrase 25-35 (n=500)
* DA Sucrase \>55 (n=100)
* At the discretion of the investigator, subject is suspected of CSID and has at least one symptom of diarrhea, abdominal pain, gas/bloating, nausea, or borborygmi at least 3x per week for the past 3 months or more.
* Subject or parent/guardian must provide informed consent/assent prior to any study procedures being performed.
* Subject is a U.S. resident.
* Subject is male or female, ages 6 months to 17 years old.
* Subject/parent or guardian is willing and able to complete necessary study procedures including following study instructions, completing electronic questionnaires via a personal mobile device, attending study visits and, in the Investigator's judgment, is sufficiently stable to participate in the study.
* Subject/ parent or guardian must be able to read or understand the English language.
* Subject or parent/guardian must have their own Android or Apple device for BYOD.
Exclusion Criteria:
* Females who are lactating or pregnant.
* Subjects with allergy to sucrose, yeast, papain, or glycerol.
* Subjects with causes of abdominal pain or altered bowel habits other than CSID such as inflammatory bowel disease, celiac disease, eosinophilic gastrointestinal disorder, pancreatitis, or gastrointestinal bleeding.
* Subjects with a history of diabetes mellitus.
* Subjects with a recent febrile illness (5 days prior to study).
* Subjects that do not have the mental capacity to understand the study requirements and are unable to comply.
* 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.
* Subject has previously used Sucraid®.
* Subject has uncontrolled systematic disease.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
17 Years
Study:
NCT05480761
Study Brief:
Protocol Section:
NCT05480761