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NCT04182633
MTT for Children With ASD Who Have Gastrointestinal Disorders
Phase 2 trial testing vancomycin, Miralax, intestinal microbiota in Autism Spectrum Disorder in 50 participants. Participants enrolled and being followed up; not accepting new ones.
28 February 2025
Quick facts
| Lead sponsor | Arizona State University |
|---|---|
| Phase | Phase 2 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 50 |
| Start date | 15 November 2019 |
| Primary completion | 28 February 2025 |
| Estimated completion | 30 December 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- vancomycin, Miralax, intestinal microbiota
- placebo vancomycin, Miralax, placebo intestinal microbiota
Conditions studied
- Autism Spectrum Disorder — all drugs for Autism Spectrum Disorder →
- Gastro-Intestinal Disorder — all drugs for Gastro-Intestinal Disorder →
- Constipation — all drugs for Constipation →
- Diarrhea — all drugs for Diarrhea →
Sponsor
Arizona State University
Who can join
Adults 5 to 17, any sex, with Autism Spectrum Disorder or Gastro-Intestinal Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The investigators propose to investigate Microbiota Transfer Therapy (MTT) for treating children with Autism Spectrum Disorder (ASD) and gastrointestinal problems (primarily constipation and/or diarrhea). MTT involves a combination of 10 days of oral vancomycin (an antibiotic to kill pathogenic bacteria), followed by a bowel cleanse, followed by 12 weeks of Fecal Microbiota (FM).
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
-
Cell therapies in the clinic.
Wang LL, Janes ME, Kumbhojkar N, Kapate N, et al · · 2021 · cited 99× · PMID 34027097 · DOI 10.1002/btm2.10214 -
Fecal Microbiota Transplantation: A New Therapeutic Attempt from the Gut to the Brain.
Xu HM, Huang HL, Zhou YL, Zhao HL, et al · · 2021 · cited 59× · PMID 33510784 · DOI 10.1155/2021/6699268 -
Current and future applications of fecal microbiota transplantation for children.
Chen CC, Chiu CH. · · 2022 · cited 29× · PMID 34781002 · DOI 10.1016/j.bj.2021.11.004 -
Interventions targeting the gut microbiota and their possible effect on gastrointestinal and neurobehavioral symptoms in autism spectrum disorder.
Takyi E, Nirmalkar K, Adams J, Krajmalnik-Brown R. · · 2025 · cited 14× · PMID 40376856 · DOI 10.1080/19490976.2025.2499580 -
Fecal microbial transplants as investigative tools in cancer.
Bohm MS, Ramesh AV, Pierre JF, Cook KL, et al · · 2024 · cited 8× · PMID 39301964 · DOI 10.1152/ajpgi.00171.2024 -
The endocannabinoidome-gut microbiome-brain axis as a novel therapeutic target for autism spectrum disorder.
Campanale A, Siniscalco D, Di Marzo V. · · 2025 · cited 2× · PMID 40605060 · DOI 10.1186/s12929-025-01145-7
Verify or expand the search:
- PubMed search for NCT04182633
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04182633 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Arizona State University
- Last refreshed: 25 April 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04182633.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing