Gastro-Intestinal Disorder Clinical Trial
Official title:
Dynamics of Gut Microbiomes in Autism Spectrum Disorder (ASD) Symptoms
Verified date | October 2023 |
Source | Children's Hospital Los Angeles |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 10 |
Est. completion date | June 2026 |
Est. primary completion date | March 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 5 Years to 17 Years |
Eligibility | Inclusion Criteria: - Age: 5-17 who have been diagnosed with non-syndromic ASD-s - Needs upper GI endoscopy - Clinical Assessment of ASD - ADOS validated diagnoses of ASD - Questionnaires: RBS-2 , KBIT, SRS, Rome III Version (QPGS- RIII), Ped QL, SSP Exclusion Criteria: - Subjects able to give consent/assent but unwilling to give informed consent/assent - Prematurity (<36 weeks) - Pregnancy: testing will be done on FMT day 0 for subjects with childbearing potential - Subjects with significant renal and liver dysfunction (creatinine > 2 mg/dl and direct bilirubin > 2 mg/dl) - Subjects with congenital or acquired immunodeficiency, or who are immunosuppressed such as neoplastic disease or organ transplantation), have received or are receiving chemotherapy, or have been diagnosed with HIV. - Subjects with syndromic disorders of defined genetic cause, and subjects who have severe sensory or motor problems (for example, blindness, deafness, seizures, cerebral palsy) - Subjects with severe food allergies |
Country | Name | City | State |
---|---|---|---|
United States | Children's Hospital Los Angles | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital Los Angeles |
United States,
Finegold SM. State of the art; microbiology in health and disease. Intestinal bacterial flora in autism. Anaerobe. 2011 Dec;17(6):367-8. doi: 10.1016/j.anaerobe.2011.03.007. Epub 2011 Apr 16. — View Citation
Finegold SM. Therapy and epidemiology of autism--clostridial spores as key elements. Med Hypotheses. 2008;70(3):508-11. doi: 10.1016/j.mehy.2007.07.019. Epub 2007 Sep 29. — View Citation
Gorrindo P, Lane CJ, Lee EB, McLaughlin B, Levitt P. Enrichment of elevated plasma F2t-isoprostane levels in individuals with autism who are stratified by presence of gastrointestinal dysfunction. PLoS One. 2013 Jul 3;8(7):e68444. doi: 10.1371/journal.pone.0068444. Print 2013. — View Citation
Gorrindo P, Williams KC, Lee EB, Walker LS, McGrew SG, Levitt P. Gastrointestinal dysfunction in autism: parental report, clinical evaluation, and associated factors. Autism Res. 2012 Apr;5(2):101-8. doi: 10.1002/aur.237. — View Citation
Hamilton MJ, Weingarden AR, Sadowsky MJ, Khoruts A. Standardized frozen preparation for transplantation of fecal microbiota for recurrent Clostridium difficile infection. Am J Gastroenterol. 2012 May;107(5):761-7. doi: 10.1038/ajg.2011.482. Epub 2012 Jan 31. — View Citation
Kang DW, Adams JB, Gregory AC, Borody T, Chittick L, Fasano A, Khoruts A, Geis E, Maldonado J, McDonough-Means S, Pollard EL, Roux S, Sadowsky MJ, Lipson KS, Sullivan MB, Caporaso JG, Krajmalnik-Brown R. Microbiota Transfer Therapy alters gut ecosystem and improves gastrointestinal and autism symptoms: an open-label study. Microbiome. 2017 Jan 23;5(1):10. doi: 10.1186/s40168-016-0225-7. — View Citation
Luna RA, Oezguen N, Balderas M, Venkatachalam A, Runge JK, Versalovic J, Veenstra-VanderWeele J, Anderson GM, Savidge T, Williams KC. Distinct Microbiome-Neuroimmune Signatures Correlate With Functional Abdominal Pain in Children With Autism Spectrum Disorder. Cell Mol Gastroenterol Hepatol. 2016 Dec 11;3(2):218-230. doi: 10.1016/j.jcmgh.2016.11.008. eCollection 2017 Mar. — View Citation
Yao MD, von Rosenvinge EC, Groden C, Mannon PJ. Multiple endoscopic biopsies in research subjects: safety results from a National Institutes of Health series. Gastrointest Endosc. 2009 Apr;69(4):906-10. doi: 10.1016/j.gie.2008.05.015. Epub 2009 Jan 10. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 24 weeks | |
Secondary | 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. | 24 weeks |
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