Fragile X syndrome
Conditions
Interventions
Probiotics in children with FXS phase 1 intervention group:Probiotic intervention was performed in the first 24 weeks after enrollment and no probiotic intervention in the second 24 weeks
Probiotics in children with FXS phase 2 intervention group:No probiotic intervention for the first 24 weeks after enrollment and probiotic intervention for the second 24 weeks
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
2 Years to 22 Years
Inclusion criteria
Inclusion criteria: Patients with FXS: 1. patients with total mutations with greater than 200 CGG repeats of the FMR1 gene by molecular genetic testing; 2. Age 3-8 years; 3. Gender is not limited; 4. No gastrointestinal treatment, no use of antibiotics and probiotics within 1 month prior to enrollment; 5. The child's guardian agrees to voluntarily participate in the study and signs the informed consent form. Normal control group: 1. exclude neurodevelopmental disorders such as FXS and ASD; 2. Age 3-8 years; 3. Gender is not limited; 4. No gastrointestinal treatment, no use of antibiotics and probiotics within 1 month prior to enrollment; 5. The child's guardian agrees to voluntarily participate in the study and signs the informed consent form.
Exclusion criteria
Exclusion criteria: Patients with FXS: 1. children who have not undergone molecular genetic testing or whose results are less than or equal to 200 CGG repeats of FMR1 gene; 2. Children with other hereditary metabolic diseases, psychiatric diseases, cranial organic diseases, severe liver and kidney diseases, cardiovascular diseases, autoimmune diseases, etc.; 3. Use of drugs or health products that affect gastrointestinal function within 1 month before enrollment; 4. The guardian of the child refused to enroll or could not complete the follow-up. Normal control group: 1. Children with other hereditary metabolic diseases, mental diseases, cranial organic diseases, severe liver and kidney diseases, cardiovascular diseases, autoimmune diseases, etc.; 2. Use of drugs or health products that affect gastrointestinal function within 1 month before enrollment; 3. Those whose guardians refuse to enroll or cannot complete the follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fecal intestinal microbiota testing; | — |
Secondary
| Measure | Time frame |
|---|---|
| Physical development assessment;Cognitive ability assessment;Nervous system development assessment;Gastrointestinal conditions such as dietary conditions and stool conditions;Area and number of eczema and urticaria;Peripheral blood samples detect IL-4, IL-6, IL-17a and IL-10 levels and analyze the number of T helper cells (Th1, Th2, Th17) and regulatory T cells (Treg); | — |
Countries
China
Contacts
Public ContactYing Han
Peking University First Hospital
Outcome results
None listed