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 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 12:13 AM
NCT ID:
NCT06279858
Eligibility Criteria:
Inclusion Criteria:
1. Subject has Fragile X syndrome with a molecular genetic confirmation of the full FMR1 mutation or mosaicism.
2. Subject is a male or female age 3 to 18 years.
3. Subject must have a parent or caretaker who is willing to participate in the whole study.
4. Subject and caregiver are able to attend the clinic regularly and reliably.
5. Subject and/or subject's parent/legal authorized representative is able to understand, read, write and speak Serbian fluently to complete study-related materials.
6. Behavioral and other non-pharmacological treatments/interventions must be stable for 4 weeks before screening and must remain stable during the period between screening and the commencement of study probiotic, and throughout the study. Minor changes in hours or times of therapy that are not considered clinically significant will not be exclusionary. Changes in therapies provided through a school program, due to school vacations, are allowed.
7. The use of concomitant medications must be stable, in terms of dose and dosing regimen, for at least 4 weeks prior to Screening and must remain stable during the period between Screening and the commencement of the study; every effort should be made to maintain stable regimens of allowed concomitant medications from the time of commencement of double-blind study medication until the last study assessment.
8. Patient's parent(s), legal authorized guardian(s), or consistent caregiver(s) can understand and sign an informed consent form to participate in the study. For subjects who are not their own legal guardian, subject's parent/legal authorized representative is able to understand and sign an informed consent to participate in the study.
9. Subject and/or subject's parent/legal authorized representative is able to understand, read, write, and speak Serbian fluently to complete study-related materials.
Exclusion Criteria:
1. Families that are not cooperative and will not follow through with the demands of this study;
2. Antibiotic use in the last two months (not counting topical antibiotics);
3. Currently taking antibiotics;
4. Any changes in medications, nutritional supplements, therapies, in the last two months, or any plans to change them during the first 3 months of probiotic treatment;
5. Diagnosis of severe gastrointestinal diseases, such as Crohn's Disease, or Ulcerative Colitis;
6. Subject has a life-threatening medical problem or other major systemic illness that compromises health or safety and/or would interfere with this study;
7. Age younger than 3 or older than 18 years.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
18 Years
Study:
NCT06279858
Study Brief:
Protocol Section:
NCT06279858