Austistic spectrum disorder
Conditions
Brief summary
Rate of children with a success, determined by the reduction of more than 50% of the composite score in the Gastrointestinal Symptoms Rating Scale (GSRS) evaluated by parents between inclusion and week 18. GSRS is validated in French and evaluates the intensity of 5 gastrointestinal symptoms (diarrhea, abdominal pain, constipation, indigestion, and reflux).
Detailed description
Improvement on autistic core symptoms and global improvement [at W0, W4, W18, W24, M12] by multiples questionnaires and scales, FMT side effects (antibiotic therapy, GM transplantation from a healthy donor): Pediatric Adverse Event Rating Scale [evaluated by the pediatrician at day (D) 0, D5, W4, W18, W24, M12], Adherence to instruction to be followed during the FMT process, drop out numbers, reasons of drop out, acceptability questionnaire - Stool consistency: Bristol Stool Form Scale [by parents from W0 to W4 and from W17 to W18] and global improvement: Caregiver Strain index [by a psychologist at W0, W4, W18, W24, M12], Pediatric Quality of Life Inventory (PedsQL) [at W0, W18, M12]
Interventions
DRUGEnema transplant of fecal microbiota 25g/100mL
Sponsors
Assistance Publique Hopitaux De Paris
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of children with a success, determined by the reduction of more than 50% of the composite score in the Gastrointestinal Symptoms Rating Scale (GSRS) evaluated by parents between inclusion and week 18. GSRS is validated in French and evaluates the intensity of 5 gastrointestinal symptoms (diarrhea, abdominal pain, constipation, indigestion, and reflux). | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement on autistic core symptoms and global improvement [at W0, W4, W18, W24, M12] by multiples questionnaires and scales, FMT side effects (antibiotic therapy, GM transplantation from a healthy donor): Pediatric Adverse Event Rating Scale [evaluated by the pediatrician at day (D) 0, D5, W4, W18, W24, M12], Adherence to instruction to be followed during the FMT process, drop out numbers, reasons of drop out, acceptability questionnaire - Stool consistency: Bristol Stool Form Scale [by parents from W0 to W4 and from W17 to W18] and global improvement: Caregiver Strain index [by a psychologist at W0, W4, W18, W24, M12], Pediatric Quality of Life Inventory (PedsQL) [at W0, W18, M12] | — |
Countries
France
Outcome results
None listed