A Phase 2 interventional study of Vancomycin and MoviPrep in Autism Spectrum Disorder and Gastrointestinal Disorder, sponsored by Arizona State University. Status unknown at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-01-09.
Sponsored by Arizona State University · Phase 2, Interventional, and Treatment
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Among 773 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 773 studies in Autism Spectrum Disorder with a site in United States, this one is the 309th largest by enrollment of the 658 interventional ones that give a count, is one of 53 that started in 2018, is one of 101 in phase 2, and was the 288th registered.
1,727 studies on the registry are indexed under Autism Spectrum Disorder; 500 are open to participants now.
Browse Autism Spectrum Disorder studies →165 of the 773 studies in Autism Spectrum Disorder with a site in United States are open now. Recruiting first, the newest first:
New York State Institute for Basic Research · Sites in United States
Ages 5–12
Massachusetts General Hospital · Sites in United States
Ages 12–17
Schweitzer Engineering Laboratories · Sites in United States
Ages 24 mo–60 mo · Healthy volunteers
Children's Hospital Medical Center, Cincinnati · Sites in United States
Ages 12–18
Bristol-Myers Squibb · Sites in United States, Australia, Canada and 1 more country
Ages 5–17
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; 298 take children under 18; 92 take healthy volunteers.
This study: 18 Years to 60 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.
773 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. 53 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 55 is close to the median of 52 across 1,370 interventional studies indexed under Autism Spectrum Disorder.
Median enrollment 50 across the 658 interventional studies, 132 across the 114 observational. Of the 522 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 773 have an industry lead sponsor. The 10 most frequent:
Arizona State University is the lead sponsor of 238 studies on the registry; 42 are open to participants now.
Arizona State University has 7 studies filed under Autism Spectrum Disorder — fewer than ten, so there is no comparison to draw.
67 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 |
Add all 67 to your calendar (.ics) → With an account.
Among the 773 studies in Autism Spectrum Disorder with a site in United States, from their registry updates:
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This is a clinical trial of Microbiota Transplant Therapy (MTT) for adults with autism spectrum disorders (ASD) who have gastrointestinal problems.
Previous research has shown that individuals with ASD have a low diversity of gut bacteria, and low diversity is generally associated with poor gastrointestinal (GI) health. We previously found that MTT therapy for children with ASD and GI symptoms was helpful in reducing their GI symptoms, reducing their ASD symptoms, and increasing their diversity of gut bacteria.
This clinical trial will investigate the hypothesis that MTT therapy will be helpful for adults with ASD who have GI symptoms.
For adults ages 18-60 years with ASD and gastrointestinal problems, the investigators propose a Phase 2 clinical trial to evaluate the safety and efficacy of MTT. The study will also determine if longer treatment is beneficial, and to conduct a longer observation after treatment stops to determine long-term safety and efficacy. The three parts of this trial are described below.
Part 1: Placebo-Controlled Treatment The trial will begin with a randomized, double-blind, placebo-controlled trial which will include a 2-week treatment with oral vancomycin (or placebo), then 1 day of Moviprep to cleanse the bowel of vancomycin and bacteria/feces (all participants, since its bowel-emptying effect cannot be blinded), followed by oral administration of Full Spectrum Microbiota (FSM) or placebo. An initial high dose of FSM (or placebo) for two days will be followed by a lower maintenance dose of FSM (or placebo) for 8 weeks.
Part 2 Extension and Cross-Over
Part 3: Follow-up There will be follow-up evaluations at 6, 12, and 18 months after treatment is stopped, to assess long-term efficacy and possible adverse effects.
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:
abnormalities at baseline on two blood safety tests: Comprehensive Metabolic Panel and Complete Blood Count with Differential.
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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.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Group A receives treatment in Part 1 and Part 2
Drug: Vancomycin · Drug: MoviPrep · Biological: Full Spectrum Microbiota
Group B receives no treatment in Part 1, but does receive treatment in Part 2
Drug: MoviPrep · Biological: Full Spectrum Microbiota
Oral vancomycin is administered to reduce pathogenic bacteria.
MoviPrep is given at the end of vancomycin therapy to remove the vancomycin and remaining bacteria prior to administering Full-Spectrum Microbiota
Gut bacteria from healthy human donors are administered orally in a pill form
Also known as: fecal microbiota transplant
Change in Childhood Autism Rating Scale (CARS) from baseline to 10 weeks
An evaluation by a trained evaluator of autism symptoms. The range is 15-60, and scores in the range of 27-30 or higher are indicative of autism.
Time frame: baseline; month 2.5, 4.5, 10.5, 16.5, 22.5
Change in Daily Stool Log (DSL) from baseline to 10 weeks
The DSL is a report of the number and type of stools over 14 days. Each stool is rated on a scale of 1-7, where 1=very hard, 4=normal, 7=very soft/liquid. The DSL is scored by the number of days of an abnormal stool (type 1-2 or 6-7) or no stool.
Time frame: baseline for 2 weeks; daily for 18 weeks, and 2 weeks at month 10, 16, 22
Change in Social Responsiveness Scale - 2 from baseline to 10 weeks of treatment
A questionnaire about social skills, where higher scores suggest more severe autism. Scores range from 0 to 195, with higher scores indicating more severe problems.
Time frame: baseline; weeks 2, 4, 6, 8, 10, 12, 14, 16, 18; months 10.5, 16.5, 22.5
Change in Aberrant Behavior Checklist from baseline to 10 weeks
a questionnaire about aberrant behaviors. Scores range from 0 to 174, with higher scores indicating more severe behaviors
Time frame: baseline; month 2.5, 4.5, 10.5, 16.5, 22.5
Change in Gastrointestinal Stool and Symptom Questionnaire for Autism, from baseline to 10 weeks
a questionnaire about GI-related symptoms.
Time frame: baseline; weeks 2, 4, 6, 8, 10, 12, 14, 16, 18; month 10.5, 16.5, 22.5
Change in Microbiome composition from baseline to 10 weeks
analysis of the bacterial composition of stool samples, at the species, genus, and phylum level
Time frame: baseline; month 1, 2.5, 3.5, 4.5, 10.5, 16.5, 22.5
Change in the Vineland Adaptive Behavior Scale - II, from baseline to 10 weeks
questionnaire about adaptive behaviors; it yields the developmental age of the participant
Time frame: baseline; month 2.5, 4.5, 22.5
Change in Ohio State University Clinical Impressions Scale, from baseline 10 weeks
assessment of autism symptoms by a clinician. It rates 10 symptoms on a scale of 1-7, with higher scores indicating worse symptoms.
Time frame: baseline; month 2.5, 4.5
Change in Parent Global Impressions, from baseline to 10 weeks
Assessment of autism symptoms. It rates 20 symptoms on a scale of 1-7, with higher scores indicating worse symptoms
Time frame: baseline; weeks 2, 4, 6, 8, 10, 12, 14, 16, 18; month 10.5, 16.5, 22.5
Plan to share: No
Ran from Jan 2018 to primary completion in Apr 2022, 51 months.
Of 67 non-industry phase 2 interventional studies under Autism Spectrum Disorder, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 63. This study's 51 months is above that.
Counting every sponsor, half of 82 studies reached it within 36 months; a quarter within 23 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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