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 @ 11:20 PM
Ignite Modification Date:
2025-12-24 @ 11:20 PM
NCT ID:
NCT04379856
Eligibility Criteria:
Inclusion Criteria:
1. Males and females with SBS secondary to surgical resection of small intestine, with or without an intact colon
2. 18-75 years of age at the time of screening
3. Female subjects must be postmenopausal (at least 2 years prior to dosing) or surgically sterile or agree to use an acceptable form of birth control from screening until 30 days after last dose. If oral contraceptives are used, Subject must have been on a stable dose for ≥6 months. (See below, "Participation of Women", for additional detail.)
4. Male subjects must agree to use an acceptable form of birth control during the study and for 90 days after the last dose. Male subjects may not donate sperm for 90 days after last dose.
5. At least 6 months since last surgical bowel resection
6. Patients may be on Parenteral support (nutrition and/or fluid and electrolytes \[PS\]) for at least some of their nutritional needs.
7. If on PS, stable administration of PS volume for 1 month (±20% vol) prior to enrollment.
8. Able to ingest solid foods and drink
9. Willing to adhere to a defined oral intake of fluids on certain days as required by protocol and based on the individual's routine daily consumption.
Exclusion Criteria:
1. Positive results on the HIV, Hepatitis, or drug screens.
2. Pregnancy or lactation
3. Body mass index \<18 or \>30 kg/m2
4. Clinically significant intestinal adhesions and/or chronic abdominal pain
5. Active Crohn's disease or IBD (as evaluated by standard procedures employed by the investigator/institution). If in remission, must be ≥12 weeks of remission prior to enrollment.
6. If on chronic systemic narcotics, the patient must have been on a stable dose for \>12 weeks
7. Inflammatory bowel disease patients who have NOT been on a stable drug treatment regimen for at least the past 3 months.
8. Visible blood in the stool within the last 3 months
9. Catheter sepsis experienced within the last 3 months
10. Known heart failure or active coronary disease
11. Known celiac disease
12. Radiation enteritis, scleroderma, coeliac disease, refractory or tropical sprue, diabetes
13. Alcohol or drug abuse within the last 12 months
14. Inadequate hepatic function as defined by: ALT and ASAST both \>2.0X ULN; TBL \>2X ULN; or ALP \>2.5X ULN
15. Inadequate renal function as defined by serum creatinine \<0.7 or \>1.3 mg/dL (in men) and \<0.6 or \>1.1 mg/dL in women.
16. Personal or family history of medullary thyroid cancer.
17. History of pancreatitis.
18. Any patient who receives insulin in their PS.
19. Any hospitalization within 1 month before screening visit
20. Systemic corticosteroids, methotrexate, cyclosporine, tacrolimus, sirolimus, infliximab, or mycophenolate mofetil (CellCept®) within 30 days of screening
21. Any use of growth hormone, or growth factors such as native GLP-2 or GLP-2 analog (teduglutide) within the last 3 months
22. Use of antibiotics within the last 30 days
23. Subject not capable of understanding or not willing to adhere to the study visit schedules and other protocol requirements.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04379856
Study Brief:
Protocol Section:
NCT04379856