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 @ 3:36 PM
Ignite Modification Date:
2025-12-24 @ 3:36 PM
NCT ID:
NCT01111292
Eligibility Criteria:
Inclusion Criteria:
* Participants must have ulcerative colitis or Crohn's disease with low grade dysplasia or polyploid dysplasia or have a history of dysplasia and increased positive beta-catenin levels confirmed by a consensus of the study pathologists (2 of 2, or 2 of 3)
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Absolute neutrophil count (ANC) \> 1,500/uL
* Platelets \> 100,000/uL
* Total bilirubin within normal institutional limits
* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\]/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\] =\< 1.5 times upper limit of normal
* Creatinine within normal institutional limits
* International normalized ratio (INR) \< 1.5
* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) from the time of baseline pregnancy test, throughout the duration of the study, and for 1 month following cessation of study drug; females must begin adequate contraception immediately following screening pregnancy test; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately; if she is pregnant, she will be immediately withdrawn from the study and followed until the birth of the child
* Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
* Subjects with life-threatening medical conditions that would preclude study treatment intervention and colonoscopy
* Participants may not be receiving any other investigational agents
* History of allergic reactions to rice or compounds of similar chemical or biologic composition to myo-inositol (i.e., urticaria, dermatologic reaction)
* Use of medications known to elevate serum blood glucose; participants on steroids are still eligible, as they will be monitored weekly for fasting blood glucose
* Participants with dysplasia-associated lesion or mass (DALM), high-grade dysplasia or invasive colonic carcinoma are excluded
* Uncontrolled intercurrent illness including, but not limited to
* Ongoing or active infection
* Symptomatic congestive heart failure
* Unstable angina pectoris
* Cardiac arrhythmia
* Chronic renal failure
* Chronic renal insufficiency
* Psychiatric illness or social situations that would limit compliance with study requirements
* Prior treatment with myo-inositol
* History of systemic chemotherapy within 18 months of screening
* Subjects taking valproic acid and/or lithium
* Diabetes mellitus
* History of total proctocolectomy
* Concomitant primary sclerosing cholangitis (PSC)
* Pregnant or lactating subjects are excluded
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01111292
Study Brief:
Protocol Section:
NCT01111292