An observational study in Autism and Gastrointenstinal Symptoms, sponsored by The University of Texas Health Science Center, Houston. Status unknown at 1 site in United States. Open to participants aged 4 Years to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-14.
Sponsored by The University of Texas Health Science Center, Houston · Observational
Among 603 studies in Autistic Disorder with a site in United States — 123 open to participants now, 152 under way, 3 of them phase 3. Autistic Disorder · United States.
Among the 603 studies in Autistic Disorder with a site in United States, this one is the 67th largest by planned enrollment of the 96 observational ones that give a count, is one of 17 that started in 2018, is one of 96 observational ones, and was the 345th registered.
1,033 studies on the registry are indexed under Autistic Disorder; 269 are open to participants now.
Browse Autistic Disorder studies →123 of the 603 studies in Autistic Disorder with a site in United States are open now. Recruiting first, the newest first:
Children's Mercy Hospital Kansas City · Sites in United States
Ages 8–12
Vanderbilt University Medical Center · Sites in United States
Ages 36 mo–72 mo
University of Wisconsin, Madison · Sites in United States
Massachusetts General Hospital · Sites in United States
Ages 7–17
Stony Brook University · Sites in United States
Ages 12–17
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 183 Autistic Disorder studies recruiting now, 33 (18%) set no upper age limit and 143 (78%) stop at 75 or younger; 148 take children under 18; 56 take healthy volunteers.
This study: 4 Years to 16 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
603 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 55 · Phase 2 122 · Phase 3 43 · Phase 4 18
First in 1997; this study’s year is marked. 17 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 60 is below the median of 102 across 190 observational studies indexed under Autistic Disorder.
Median enrollment 44 across the 504 interventional studies, 135 across the 96 observational. Of the 408 that completed or were terminated, 143 (35%) have results posted.
This tab as a report to print or save as PDF → With an account.
73 of 603 have an industry lead sponsor. The 10 most frequent:
The University of Texas Health Science Center, Houston is the lead sponsor of 899 studies on the registry; 215 are open to participants now.
Of its 174 completed or terminated interventional studies of FDA-regulated products, 142 (82%) have results posted.
The University of Texas Health Science Center, Houston has 3 studies filed under Autistic Disorder — fewer than ten, so there is no comparison to draw.
34 of the studies in Autistic Disorder with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT02914951Yale UniversityCognitive-Behavioral Therapy for Irritability in Children With Autism Spectrum Disorder and Intellectual Disability | 2026-12 |
| NCT06627205Stanford UniversitySleep Restriction Therapy (SRT) for Sleep Problems in Children With Autism | 2026-12 |
| NCT04805957Rutgers, The State University of New JerseyValidation Digital Bio-markers During Sulforaphane Treatment. | 2026-12-01 |
| NCT07421830Northeastern UniversityAn Empowering Parent Training Intervention to Increase Physical Activity in Preschool Aged Children With Autism | 2026-12-31 |
| NCT02000284University of ArkansasMitochondrial Dysfunction in Autism Spectrum Disorder | 2026-12-31 |
Add all 34 to your calendar (.ics) → With an account.
Among the 603 studies in Autistic Disorder with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study's primary aim is to explore the potential differences in the gut mycobiome of children with autism spectrum disorder compared to otherwise healthy children. The secondary objective of this study is to evaluate whether the presence of specific species of fungi (e.g. Candida tropicalis, C. albicans, or Saccharomyces cerevisiae), in stool: 1) correlates with increased gastrointestinal symptoms; 2) correlates with evidence of increased behavioral problems (as assessed by the Aberrant Behavior Checklist or Social Responsiveness Scale-2); or 3) plays the same role as a constituent of commensal gut microflora as in normal controls. The scale indicates severity of social deficits in the autism spectrum as mild, moderate or severe. Additionally, the study aims to compare the fecal and oral fungi in these children because many fecal mycobiota are felt to originate in the oropharynx.
Healthy subjects will be recruited from The University of Texas Health Science Center at Houston general pediatrics clinic and adolescent clinic.
Children with autism are referred to The University of Texas Health Science Center at Houston general pediatrics clinic and adolescent clinic.
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.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
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.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
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.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
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.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
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.
Fecal Mycobiome Composition as assessed by sequencing of fecal fungal species
Time frame: day 1
Presence of fungal species Candida tropicalis
Time frame: day 1
Presence of fungal species Candida albicans
Time frame: day 1
Presence of fungal species Saccharomyces cerevisiae
Time frame: day 1
Gastrointentinal (GI) symptoms as assessed by the GI Symptoms Severity Index
Time frame: day 1
Behavioral problems as assessed by the Aberrant Behavior Checklist (ABC)
Time frame: day 1
Behavioral problems as assessed by the Social Responsiveness Scale-2 (SRS-2)
Time frame: day 1
Oral Mycobiome Composition as assessed by sequencing of oral fungal species
Time frame: day 1
Gut inflammation as assessed by fecal calprotectin levels
Time frame: day 1
Antifungal immunity as assessed by serum dectin 1 levels
Time frame: day 1
Started Mar 2018 (actual). Primary completion is estimated for May 2019, 13 months after the start.
Of 57 non-industry observational studies under Autistic Disorder, half reached primary completion within 72 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 144. This study's planned 13 months is below that.
Counting every sponsor, half of 65 studies reached it within 43 months; a quarter within 20 and three quarters within 120.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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The University of Texas Health Science Center, Houston →