A Phase 1 interventional study of FMT versus placebo in Autism Spectrum Disorder (ASD) and Gastro-Intestinal Disorder, sponsored by Children's Hospital Los Angeles. Active, not recruiting at 1 site in United States. Open to participants aged 5 Years to 17 Years. Per ClinicalTrials.gov, last updated 2023-11-02.
Sponsored by Children's Hospital Los Angeles · Phase 1, Interventional, and Treatment
Among 772 studies in Autism Spectrum Disorder with a site in United States — 165 open to participants now, 204 under way, 9 of them phase 3. Autism Spectrum Disorder · United States.
Among the 772 studies in Autism Spectrum Disorder with a site in United States, this one is the 576th largest by planned enrollment of the 658 interventional ones that give a count, is one of 60 that started in 2019, is one of 44 in phase 1, reaches primary completion later than 41 of the 202 other live ones, and was the 296th registered.
1,724 studies on the registry are indexed under Autism Spectrum Disorder; 500 are open to participants now.
Browse Autism Spectrum Disorder studies →165 of the 772 studies in Autism Spectrum Disorder with a site in United States are open now. Recruiting first, the newest first:
Massachusetts General Hospital · Sites in United States
Schweitzer Engineering Laboratories · Sites in United States
Children's Hospital Medical Center, Cincinnati · Sites in United States
Bristol-Myers Squibb · Sites in United States, Australia, Canada and 1 more country
Bristol-Myers Squibb · Sites in United States, France, Germany and 7 more countries
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 349 Autism Spectrum Disorder studies recruiting now, 48 (14%) set no upper age limit and 294 (84%) stop at 75 or younger; 297 take children under 18; 92 take healthy volunteers.
This study: 5 Years to 17 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
772 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 52 · Phase 2 117 · Phase 3 33 · Phase 4 16
First in 2004; this study’s year is marked. 60 started in 2019.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 10 is below the median of 52 across 1,368 interventional studies indexed under Autism Spectrum Disorder.
Median enrollment 50 across the 658 interventional studies, 131 across the 113 observational. Of the 521 that completed or were terminated, 174 (33%) have results posted.
This tab as a report to print or save as PDF → With an account.
89 of 772 have an industry lead sponsor. The 10 most frequent:
Children's Hospital Los Angeles is the lead sponsor of 152 studies on the registry; 46 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Children's Hospital Los Angeles has 5 studies filed under Autism Spectrum Disorder — fewer than ten, so there is no comparison to draw.
68 of the studies in Autism Spectrum Disorder with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06706674Phase 3Intra-Cellular Therapies, Inc.Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder (ASD) in Pediatric Patients | 2027-06-21 |
| NCT06690398Phase 3Intra-Cellular Therapies, Inc.Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder in Pediatric Patients | 2027-06-21 |
| NCT07670000Natalia PoluektovaMental And Speech Developmental Delay Autism Spectrum-Type Behavioral Disorder | 2026-11 |
| NCT04242355Yale UniversityTranscranial Magnetic Stimulation on Neural and Behavioral Facets of Social Cognition in Autism Spectrum Disorder | 2026-12 |
| NCT06059352Loma Linda UniversitySleep and Central Auditory Processing Disorder in Autism Spectrum Disorder | 2026-12 |
Among the 772 studies in Autism Spectrum Disorder with a site in United States, from their registry updates:
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The purpose of this study is to find out if transplant of fecal matter (stool), also known as fecal microbiota transplantation (FMT), from a healthy person into the intestines of children and young adults with Autism Spectrum Disorder (ASD).
For this study children between the ages of 5-17years will be recruited over 2 years. Children will be recruited who receive an ASD diagnosis using the gold-standard Autism Diagnosis Observation Schedule -2 (ADOS-2) using module 1, 2 or 3 (none, limited or no moderate expressive language). Children diagnosed with these modules of the ADOS-2 may be at greater risk for GI disorders and rigid-compulsive behaviors. Additional assessment of rigid-compulsive behaviors and social communication will be done using the Repetitive Behavioral Scales-Revised (RBS-R) and Social Responsiveness Scale-2 (SRS-2), respectively. KBIT (the Kaufman Brief Intelligence Test) is used at baseline to obtain patient IQ. Total evaluation time is approximately 90 minutes. Following baseline symptom evaluation, a medical exam will be performed to determine whether each child is expressing specific GI symptoms. In addition, parents will fill out the Questionnaire for Pediatric Gastrointestinal Symptoms- Rome III (QPGS-III). Once an ASD diagnosis is confirmed, FMT treatment will be initiated, which typically occurs within 4-6 weeks of the initial diagnosis. Half 50% of the children (n=5) will receive the equivalent of 50 g of stools from a healthy donor into the jejunum through upper endoscopy and the other 50% off children (n=5) will receive Saline solution as Placebo control through upper endoscopy.
Subjects will have a total of 5 visits within 24 weeks including phone call follow up on Day 7 after FMT.
Nearly 1 in 60 children are diagnosed with ASD, a dramatic increase from the start of the 21st century. Although most children with ASD exhibit core social communication deficits, very limited interests, repetitive behaviors and sensory problems, the severity of symptoms and how well each child responds to standard behavioral therapies can vary tremendously from patient to patient. This makes it difficult to enact effective interventions. Other variables also influence the outcomes for ASD patients, including age at first diagnosis, access to care, the quality of treatments and the expertise of interventionists.
Children with ASD also have medical disturbances, which affects their quality of life and compliance in intervention programs. For example, approximately 40 percent of children with ASD have gastrointestinal disturbances (GIDs). Genetics plays a substantial role in risk, but scientists also have determined that non-heritable factors can trigger the expression and severity of ASD symptoms. Clinical research studies from PI laboratories have focused on the gut-brain link that influences ASD symptoms, how a child functions and even responds to interventions .
The investigators hypothesize that children with ASD will tolerate single endoscopic delivery of fecal transplant therapy which will modify their gut microbial profile leading to reduction of repetitive and rigid-compulsive behaviors, based on the Repetitive Behavioral Scales-Revised (RBS-R). Secondary outcomes include improved score in social responsiveness scale and gastrointestinal symptoms . Investigators propose a phase I safety study for the use of FMT in children with Autism Spectrum Disorder.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Placebo Comparator placebo into the jejunum through upper endoscopy.
Biological: FMT versus placebo
Active Comparator: Donor Stool Transplant Arm 2 will get FMT (Fecal Microbial Transplant) with Healthy Donor Stool into the jejunum through upper endoscopy.
Biological: FMT versus placebo
Biological/Vaccine: Fecal Microbial Transplant versus placebo Fecal Transplant via endoscopy. Other Names: FMT
Also known as: fecal microbial transplant vs placebo
Primary Outcome Measures, safety and tolerability
The primary Outcome is safety of FMT and also it is measured by any symptom changes in obsessive/compulsive and repetitive behaviors using the RBS-R questionnaire.
Time frame: 24 weeks
Secondary Outcome Measures, symptom improvement
Secondary endpoints will include cognitive improvement using language use in a 10 minute interactive session, Social Responsiveness Scale-2. The SRS-2 is newly available (Western Psychological Services). It is a parent 65-item questionnaire that provides a continuous quantitative measure of three DSM domains, including social behavior, communication, and restricted and repetitive behaviors, normed in typically developing (T-score=50, sd=10) and ASD populations. The SRS-2 offers new DSM-5 subscales. The SRS is used in a variety of clinical and research settings. T-scores of 65 correlate highly with an ASD diagnosis, but do not substitute for the ADOS. Changes in SRS T-scores have been used as a measure of social behavior change over time.
Time frame: 24 weeks
Plan to share: No
Started Aug 2019 (actual). Primary completion is estimated for Mar 2026, 79 months after the start.
Of 35 phase 1 interventional studies under Autism Spectrum Disorder, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 27. This study's planned 79 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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