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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-520539-17-00 | EU Trial (CTIS) Number |
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| Name | Class |
|---|---|
| Fondation initiative autisme | UNKNOWN |
| Fondation Erie | UNKNOWN |
| Biocodex microbiota fondation | UNKNOWN |
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Autism Spectrum Disorders (ASD), affect approximately 1% of the general population and are characterized by impairments in social communication associated with repetitive/stereotyped behaviors. Approximately one-third of these patients display gastrointestinal (GI) symptoms, and a growing number of studies suggest abnormalities of gut microbiota in ASD. Gut microbiota and the brain interact through complex pathways. Preliminary evidence in adults with ASD suggests that modulation of the gut microbiota by probiotics and/or prebiotics and more recently by fecal microbiota transplantation could improve GI symptoms but also socio-communication deficit, with persistent improvement at year 2.
Screening :
Screening will be done in ASD units of child psychiatry departments of Robert Debré
Information of patients and their families Information will be delivered in the child psychiatry department of Robert Debré hospital.
Inclusion Consent will be collected in CIC of Robert Debré hospital during the initial visit by child psychiatrist 7 to 15 days after information from the patient's family.
Patient follow-up during trial Initial visit: for parents and patient information. Further visits (W4, W18, W24, M12): treatment administrations will be done at the CIC. Subjects will be evaluated on efficacy and safety and acceptability. Stool, urine and blood samples will be collected.
Phone visits (W11 and M9): Safety and the Acceptability questionnaire (parents) will be evaluated.
Products: donor and transplant preparation
Same administration schedule in FMT
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Felictia Arm | Experimental | FMT |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FMT Protocol | Drug | FMT protocol Samples (urine, blood, stool) collection Psychological examination Pediatric quality of life Scale Bristol Stool form Scale |
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| Measure | Description | Time Frame |
|---|---|---|
| Score of the Gastrointestinal Symptoms Rating Scale (GSRS) | Assess initial efficacy on gastrointestinal (GI) symptoms of fecal microbiota transplantation (FMT) in children (36 to 72 months) with autism spectrum disorders (ASD (FMT) The Gastrointestinal Symptoms Rating Scale (GSRS) uses 15 items rated on a 7-point scale to assess gastrointestinal symptom severity, with total scores ranging from 15 (no symptoms) to 105 (very severe symptoms). Higher GSRS scores indicate more severe symptoms and a worse gastrointestinal outcome. | Week 18 |
| Measure | Description | Time Frame |
|---|---|---|
| Score of Vineland Adaptative Behavior Composite 3 scale | Estimate the effect of FMT on autistic core symptoms and global functioning (socio adaptivecapacities, social cognition, repetitive and stereotyped behaviors) The Vineland Adaptive Behavior Scales (VABS) standard scores for each domain and the overall Adaptive Behavior Composite (ABC) range from 20 (minimum) to 160 (maximum), with a mean of 100 and a standard deviation of 15. Higher Vineland scores indicate better adaptive functioning and more positive outcomes, whereas lower scores reflect greater impairment in adaptive behavior |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pierre ELLUL, MD | Contact | 0033140034635 | pierre.ellul@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Pierre ELLUL, MD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Robert Debré Hospital | Paris | Ap-hp / DRCI | 75019 | France |
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| Day 0, Week 4, Week 18, Week 24, Month 12 |
| Score of Pediatric Adverse Event Rating Scale | FMT side effects (antibiotic therapy, GM transplantation from a healthy donor): Pediatric Adverse Event Rating Scale [evaluated by the investigator at day (D) 0, D5, W4, W18, W24, M12The Pediatric Adverse Event Rating Scale (PAERS) uses a combined score for each symptom that ranges from 0 (no symptom) to 5 (most severe/extreme symptom with impairment), based on symptom presence, functional impairment, and severity. Higher PAERS scores indicate more severe or impactful adverse events, representing a worse outcome] | Day 0, Day 5, Week 4, Week 18, Week 24, Month 12 |
| Tolerability: Score of bristol Stool form | Estimate FMT tolerability: completion of the FMT process and acceptability questionnaire (parents) | Day 0, Week 4, Week 18, Week 24, Month12 |
| Score of Pediatric Quality of Life Inventory | Estimate FMT impact on children and parent's quality of life | Day 0, Week 18, Month 12 |
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C053075 | FMT protocol |
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