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 @ 3:28 AM
Ignite Modification Date:
2025-12-25 @ 3:28 AM
NCT ID:
NCT05120505
Eligibility Criteria:
Inclusion Criteria:
* Genetic testing confirms the diagnosis of FXS
* Participate in the study with the informed consent of the guardian
* BMI\>the 3rd percentile
* Not taking more than 2 therapeutic drugs
* Able to receive regular follow-up visits
Exclusion Criteria:
* Malnutrition
* Primary heart disease
* Severe infection or acute clinical illness
* Gastrointestinal, renal, or hepatic disease
* Previous history of lactic acidosis
* previous use of metformin intolerant
* Use of angiotensin converting enzyme inhibitors, use of anticoagulants, vitamin B12 deficiency, alcohol consumption
* Unstable systemic diseases other than FXS
* Changes in clinical medication
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
16 Years
Study:
NCT05120505
Study Brief:
Protocol Section:
NCT05120505