Autism Spectrum DisorderPhase 2FELICITANCT07105267
Open Label Phase IIa Trial Evaluating the Effect and Safety of Transplantation of Fecal Microbiota in Children With Autism Spectrum Disorders and Gastrointestinal Symptoms
A Phase 2 study testing FMT Protocol in people with Autism Spectrum Disorder and Fecal Microbiota Transplantation (FMT), run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Autism Spectrum Disorders (ASD), affect approximately 1% of the general population and are characterized by impairments in social communication associated with repetitive/stereotyped behaviors. Read more about this study
- Who is it for?
- Ages 36 to 72 months
- Conditions the study is for
- Autism Spectrum Disorder, Fecal Microbiota Transplantation (FMT)
- What is being tested?
- FMT Protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2025to 1 Apr 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 36 to 72 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASD diagnosis based on DSM-5 criteria
- Gastrointestinal symptoms: at least 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
- Age between 36 and 72 months
- Consent from all legal guardians
- Social insurance affiliation
Who cannot join
- Severe intellectual deficit (IQ<30) or another uncontrolled comorbidity (e.g. epilepsy)
- Recent change in ASD global care (cognitive behavioral therapy 6 weeks before inclusion)
- Actual or past psychotropic medication
- Contraindications to colon preparation (Picoprep®) and/or to Meopa)
- Severe or uncontrolled gastrointestinal symptoms (e.g. urgent treatment needed)
- Undernutrition (age related BMI < 3rd percentile)
Show all 12Show fewer
- Inflammatory bowel disease
- Exclusive diet (gluten- or sugar-free)
- Rectal enema contraindication
- Antibiotic or antifungal therapy 3 months before inclusion
- Probiotics 2 months before inclusion or FMT 12 months before inclusion
- Vancomycin or Picoprep® or Meopa (including excipients) known allergy or intolerance Experimental therapeutic trial participation 3 months before inclusion
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Robert Debré Hospital
Paris, Ap-hp / DRCI, 75019
Pierre ELLUL, MD, 0033140031635, pierre.ellul@aphp.fr
About this study
Official title: A Proof of Concept Study : Open Label Phase IIa Trial Evaluating the Effect and Safety of Transplantation of Fecal Microbiota in Children With Autism Spectrum Disorders and Gastrointestinal Symptoms
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.
Read the detailed description
- 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
- D1 to D4: Vancomycin (10mg/kg, 4 times a day). 1st dose in the CIC, the 3 others at home
- D4: Picoprep® treatment at home
- D5: First FMT using rectal enema (100ml = 25g of stool from donor) using Foley probe (rectal administration) in CIC
- D12: Second FMT using rectal enema (100ml = 25g of stool from donor) using Foley probe (rectal administration) in CIC
- D19: Third FMT using rectal enema (100ml = 25g of stool from donor) using Foley probe (rectal administration) in CIC
- Being tested
- FMT Protocol
- Keywords
- Austim Spectrum Disorder, FMT, gastrointestinal symptom,
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FMT ProtocolDrug
FMT protocol Samples (urine, blood, stool) collection Psychological examination Pediatric quality of life Scale Bristol Stool form Scale
| Study group | Role | What they receive |
|---|---|---|
| Felictia Arm | Experimental | FMT Receives: Drug: FMT Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 18
Secondary outcomes (4)
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
Measured: 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]
Measured: 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)
Measured: 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
Measured: Day 0, Week 18, Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation initiative autisme, Fondation Erie, Biocodex microbiota fondation
- Responsible party
- Sponsor
- Investigators
- Pierre ELLUL, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07105267
- Sponsor's protocol ID
- APHP241418
- Other IDs
- 2025-520539-17-00, 2025
- Acronym
- FELICITA
- Status last verified
- Jul 2025
- First submitted
- 21 Jul 2025
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof of Concept Study : Open Label Phase IIa Trial Evaluating the Effect and Safety of Transplantation of Fecal Microbiota in Children With Autism Spectrum Disorders and Gastrointestinal Symptoms
- ClinicalTrials.gov ID
- NCT07105267
- Acronym / sponsor ID
- FELICITA / APHP241418
- Keywords
- Austim Spectrum Disorder, FMT, gastrointestinal symptom,
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Fondation initiative autisme, Fondation Erie, Biocodex microbiota fondation
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 5 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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
- D1 to D4: Vancomycin (10mg/kg, 4 times a day). 1st dose in the CIC, the 3 others at home
- D4: Picoprep® treatment at home
- D5: First FMT using rectal enema (100ml = 25g of stool from donor) using Foley probe (rectal administration) in CIC
- D12: Second FMT using rectal enema (100ml = 25g of stool from donor) using Foley probe (rectal administration) in CIC
- D19: Third FMT using rectal enema (100ml = 25g of stool from donor) using Foley probe (rectal administration) in CIC
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Felictia Arm | Experimental | Drug: FMT ProtocolFMT |
Who may qualify
- Ages
- 36 to 72 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- ASD diagnosis based on DSM-5 criteria
- Gastrointestinal symptoms: at least 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
- Age between 36 and 72 months
- Consent from all legal guardians
- Social insurance affiliation
Key exclusion criteria (12 listed)
- Severe intellectual deficit (IQ<30) or another uncontrolled comorbidity (e.g. epilepsy)
- Recent change in ASD global care (cognitive behavioral therapy 6 weeks before inclusion)
- Actual or past psychotropic medication
- Contraindications to colon preparation (Picoprep®) and/or to Meopa)
- Severe or uncontrolled gastrointestinal symptoms (e.g. urgent treatment needed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FMT ProtocolFMT protocol Samples (urine, blood, stool) collection Psychological examination Pediatric quality of life Scale Bristol Stool form Scale | Drug | Felictia Arm |
Primary outcome
Score of the Gastrointestinal Symptoms Rating Scale (GSRS)
Time frame: Week 18
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.
4 secondary outcomes
Score of Vineland Adaptative Behavior Composite 3 scale
Time frame: Day 0, Week 4, Week 18, Week 24, Month 12
Score of Pediatric Adverse Event Rating Scale
Time frame: Day 0, Day 5, Week 4, Week 18, Week 24, Month 12
Tolerability: Score of bristol Stool form
Time frame: Day 0, Week 4, Week 18, Week 24, Month12
Score of Pediatric Quality of Life Inventory
Time frame: Day 0, Week 18, Month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
Related trials for Autism Spectrum Disorder
Recruiting
Cerebellar Transcranial Direct Current Stimulation (tDCS) in Children With Autism Spectrum Disorder: Raynor Cerebellum Project
Autism Spectrum Disorder
Recruiting
Effectiveness of Clown Therapy in Facilitating Dental Visits for Children With Autism Spectrum Disorder
Autism Spectrum Disorder (ASD
Not yet recruiting
Transdiagnostic Sleep and Circadian Treatment for Autistic Adolescents
Sleep, Autism Spectrum Disorder
RecruitingObservational study
Effectiveness of the Autism Pupil Screen (APS) Detect Pupillometer for Identifying Autism Spectrum Disorder (ASD) in Routine Healthcare
Autism Spectrum Disorder
Recruiting
Impact of an E-Learning Coaching for Parents of Young Children With Autism
Autism Spectrum Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pierre ELLUL, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FMT Protocol in people with Autism Spectrum Disorder and Fecal Microbiota Transplantation (FMT), run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pierre ELLUL, MD (0033140034635, pierre.ellul@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score of the Gastrointestinal Symptoms Rating Scale (GSRS) (time frame: Week 18). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025; AzTrials last refreshed its copy on 31 Oct 2026.