Allogeneic faecal microbiota, pooled for Autism spectrum disorder|Gastrointestinal disorder

Inclusion criteria

• {"criterion_text":"-ASD diagnosis based on DSM-5 criteria"}
• {"criterion_text":"-Gastrointestinal symptoms: at least 1 a score of 5 on 1 of the 5 GSRS domains (diarrhea, abdominal pain, constipation, indigestion, reflux) for over a period of 1 year or more"}
• {"criterion_text":"-Age between 36 and 72 months"}
• {"criterion_text":"-Consent from all legal guardians"}
• {"criterion_text":"-Social insurance affiliation"}

Exclusion criteria

• {"criterion_text":"-Severe intellectual deficit (IQ<30) or another uncontrolled comorbidity (e.g. epilepsy)"}
• {"criterion_text":"-Recent change in ASD global care (cognitive behavioral therapy 6 weeks before inclusion)"}
• {"criterion_text":"-Actual or past psychotropic medication"}
• {"criterion_text":"-Contraindications to colon preparation (Picoprep®) and/or to Meopa®)"}
• {"criterion_text":"-Severe or uncontrolled gastrointestinal symptoms (e.g. urgent treatment needed)"}
• {"criterion_text":"-Undernutrition (age related BMI < 3rd percentile)"}
• {"criterion_text":"-Inflammatory bowel disease"}
• {"criterion_text":"-Exclusive diet (gluten- or sugar-free)"}
• {"criterion_text":"-Rectal enema contraindication"}
• {"criterion_text":"-Antibiotic or antifungal therapy 3 months before inclusion"}
• {"criterion_text":"-Probiotics 2 months before inclusion or FMT 12 months before inclusion"}
• {"criterion_text":"-Vancomycin or Picoprep® or Meopa® (including excipients) known allergy or intolerance"}
• {"criterion_text":"-Experimental therapeutic trial participation 3 months before inclusion"}

Primary endpoints

• {"endpoint_text":"-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).","definition_or_measurement_approach":"Success defined as reduction of more than 50% of the composite GSRS score evaluated by parents between inclusion and week 18. GSRS is validated in French and evaluates intensity of five GI symptoms (diarrhea, abdominal pain, constipation, indigestion, reflux)."}

Secondary endpoints

• {"endpoint_text":"-Improvement on autistic core symptoms and global improvement [at W0, W4, W18, W24, M12] by multiples questionnaires and scales","definition_or_measurement_approach":"Measured by multiple questionnaires and scales at W0, W4, W18, W24 and M12 (timepoints specified)."}
• {"endpoint_text":"-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]","definition_or_measurement_approach":"Safety assessed using the Pediatric Adverse Event Rating Scale evaluated by the pediatrician at D0, D5, W4, W18, W24 and M12."}
• {"endpoint_text":"-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]","definition_or_measurement_approach":"Adherence, dropout rates/reasons and acceptability assessed; stool consistency by Bristol Stool Form Scale by parents (W0-W4 and W17-W18); global improvement by Caregiver Strain Index assessed by psychologist at W0, W4, W18, W24, M12."}
• {"endpoint_text":"-Pediatric Quality of Life Inventory (PedsQL) [at W0, W18, M12]","definition_or_measurement_approach":"PedsQL administered at W0, W18 and M12 to assess pediatric quality of life."}

France

Earliest CTIS Part Ii Submission Date

29-04-2025

Latest Decision Or Authorization Date

07-05-2025

Processing Time Days

8

Number Of Sites

2

Number Of Participants

5

Primary sponsor

Full Name

Assistance Publique Hopitaux De Paris

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France

Third parties

• {"country":"","full_name":"Fondation Erié","duties_or_roles":"Source of monetary support","organisation_type":""}
• {"country":"","full_name":"Fondation Initiatives Autisme","duties_or_roles":"Source of monetary support","organisation_type":""}
• {"country":"","full_name":"Biocodex Microbiota Foundation","duties_or_roles":"Source of monetary support","organisation_type":""}