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:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT02354560
Eligibility Criteria:
Inclusion Criteria:
* ages: 10-17 years old.
* A lack of known sensitivity to ERYTHROMYCIN or other macrolide.
* at the relevant subgroup - existence of polyps in the colon or Ileo-anal pouch that classified as adenomas and the size isn't bigger than 10 mm and there's no high grade dysplasia and that not yet need immediate resection of the colon rectal but just a surveillance.
* In the relevant subgroup- existence of polyps in the duodenum that do not require surgery and aren't bigger than 10 mm and with out high grade dysplasia.
* In the relevant subgroup- a tumor that classified as stomach or pelvic desmoid that not yet need immediate resection and which can be measured by ultrasound or MRI.
Exclusion Criteria:
* below 10 years old or above 18 years old.
* sensitivity to ERYTHROMYCIN or other macrolide.
* Ileo-anal pouch without adenomas.
* existence of polyps that are classified as adenomas which are bigger than 10 mm and/or with histological of high grade dysplasia.
* Taking medicines that have interactions with ERYTHROMYCIN such as: Carbamazepine, Cyclosporine, barbiturate, PHENYTOIN, Disopyramide, Lovastatin, Bromocriptine: it is recommended to keep careful attention over their Concentrations in the blood and to match the dose.
* significant personal of familial history of ventricular arrhythmia and/or Long QT interval per ECG, or consumption of drugs that may cause prolonged QT.
* Recruitment of children whom suffer from FAP in addition to other diseases is subject to a joint decision of the PI and the study pediatrician.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
17 Years
Study:
NCT02354560
Study Brief:
Protocol Section:
NCT02354560