AutismNCT03494088
Mycobiome Evaluation in Children With Autism & GI Symptoms
An observational study of Autism and Gastrointenstinal Symptoms, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 4 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism, Gastrointenstinal Symptoms
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2018to 1 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 4 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: 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.
Who may be able to join
- for autistic children with GI symptoms: confirmed diagnosis of autism spectrum disorder (ASD) and its severity (DSM-5: 299.00) by Autism Diagnostic Interview (ADI-R), Social Communication Questionnaire (SCQ), and Autism Diagnostic Observation SChedule-2 (ADOS-2); substantial gastrointestinal symptoms (as indicated by score of greater than 7 on the Gastrointestinal Symptoms Severity Index)
- for autistic children without GI symptoms: confirmed diagnosis of autism spectrum disorder (ASD) and its severity (DSM-5: 299.00) by Autism Diagnostic Interview (ADI-R), Social Communication Questionnaire (SCQ), and Autism Diagnostic Observation SChedule-2 (ADOS-2)
- for controls: healthy children
Who cannot join
- severe sensory impairment
- brain injury
- major psychiatric illness (e.g., psychotic disorders that might interfere with assessment). (however, children with common psychological problems such as depression and attention deficit hyperactivity disorder will not be excluded, given that doing so would result in a sample of children with ASD that would be unrepresentative of the pediatric ASD population as a whole.)- children who appear genetically syndromic (based on exam in the pediatric GI clinic)
- taking immunosuppressive medications
- abnormal screening labs
- GI diseases
Show all 13Show fewer
- allergy to antibiotics
- fever or a pre-existing adverse event monitored in the study
- known history of hepatitis B/C or HIV
- known pregnancy
- use of probiotics in the last 60 d
- use of oral antibiotics/anti-fungal during the previous 2 weeks
- indwelling catheters/prosthetic devices
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Jane J Alookaran, MD, 713-797-7429, Jane.J.Alookaran@uth.tmc.edu
About this study
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.
- Conditions
- Autism, Gastrointenstinal Symptoms
- Keywords
- Autism, Abdominal Pain
- Medical subject headings
- Autistic Disorder, Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children with Autism with gastrointestinal (GI) symtpoms | Not described | |
| Children with Autism without gastrointestinal (GI) symtpoms | Not described | |
| Healthy Children | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fecal Mycobiome Composition as assessed by sequencing of fecal fungal species
Measured: day 1
Secondary outcomes (9)
Presence of fungal species Candida tropicalis
Measured: day 1
Presence of fungal species Candida albicans
Measured: day 1
Presence of fungal species Saccharomyces cerevisiae
Measured: day 1
Gastrointentinal (GI) symptoms as assessed by the GI Symptoms Severity Index
Measured: day 1
Behavioral problems as assessed by the Aberrant Behavior Checklist (ABC)
Measured: day 1
Behavioral problems as assessed by the Social Responsiveness Scale-2 (SRS-2)
Measured: day 1
Oral Mycobiome Composition as assessed by sequencing of oral fungal species
Measured: day 1
Gut inflammation as assessed by fecal calprotectin levels
Measured: day 1
Antifungal immunity as assessed by serum dectin 1 levels
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2018
- Study start22 Mar 2018
- Primary completion1 May 2019 (estimated)
- Study completion1 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Baylor College of Medicine
- Responsible party
- Principal investigator, Jane J Alookaran, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03494088
- Sponsor's protocol ID
- HSC-MS-17-1015
- Status last verified
- May 2018
- First submitted
- 22 Mar 2018
- Last updated
- 14 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mycobiome Evaluation in Children With Autism & GI Symptoms
- ClinicalTrials.gov ID
- NCT03494088
- Acronym / sponsor ID
- HSC-MS-17-1015
- Conditions
- Autism, Gastrointenstinal Symptoms
- Keywords
- Autism, Abdominal Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Baylor College of Medicine
- Study start
- 22 Mar 2018 (actual)
- Primary completion
- 1 May 2019 (estimated)
- Study completion
- 1 May 2019 (estimated)
- First posted
- 11 Apr 2018 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Children with Autism with gastrointestinal (GI) symtpoms | – | – |
| Children with Autism without gastrointestinal (GI) symtpoms | – | – |
| Healthy Children | – | – |
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 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.
Key inclusion criteria (3 listed)
- for autistic children with GI symptoms: confirmed diagnosis of autism spectrum disorder (ASD) and its severity (DSM-5: 299.00) by Autism Diagnostic Interview (ADI-R), Social Communication Questionnaire (SCQ), and Autism Diagnostic Observation SChedule-2 (ADOS-2); substantial gastrointestinal symptoms (as indicated by score of greater than 7 on the Gastrointestinal Symptoms Severity Index)
- for autistic children without GI symptoms: confirmed diagnosis of autism spectrum disorder (ASD) and its severity (DSM-5: 299.00) by Autism Diagnostic Interview (ADI-R), Social Communication Questionnaire (SCQ), and Autism Diagnostic Observation SChedule-2 (ADOS-2)
- for controls: healthy children
Key exclusion criteria (13 listed)
- severe sensory impairment
- brain injury
- major psychiatric illness (e.g., psychotic disorders that might interfere with assessment). (however, children with common psychological problems such as depression and attention deficit hyperactivity disorder will not be excluded, given that doing so would result in a sample of children with ASD that would be unrepresentative of the pediatric ASD population as a whole.)- children who appear genetically syndromic (based on exam in the pediatric GI clinic)
- taking immunosuppressive medications
- abnormal screening labs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fecal Mycobiome Composition as assessed by sequencing of fecal fungal species
Time frame: day 1
9 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2018.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism and Gastrointenstinal Symptoms, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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 3 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 14 May 2018. 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 United States. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jane J Alookaran, MD (713-500-6098, Jane.J.Alookaran@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fecal Mycobiome Composition as assessed by sequencing of fecal fungal species (time frame: day 1). 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 14 May 2018.