Evidence map›Paper›PMID 28122648›Full record

Trial reportMicrobiome2017

Microbiota Transfer Therapy alters gut ecosystem and improves gastrointestinal and autism symptoms: an open-label study.

Dae-Wook Kang, James B Adams, Ann C Gregory, Thomas Borody, Lauren Chittick, Alessio Fasano, Alexander Khoruts, Elizabeth Geis, Juan Maldonado, Sharon McDonough-Means and 7 more

12 registry-linked trialsOpen access · goldAbstract readClinical Trial
In one paragraph

Trial report in Microbiome, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 12 registered trials, which are not on this map. Cited by 741 papers, 13 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
741citing papers in PubMed, 13 pooled it
52.1field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02504554 phase1 / phase2completednot on this map

Treating Gastrointestinal Problems in Children With Autism Using Beneficial Bacteria Treatment (BBT)

TypeinterventionalSponsorArizona State UniversityRan2014 to 2016Enrolled18ConditionsGastrointestinal Problems, Autism Spectrum DisordersArmsoral Vancomycin, MoviPrep, Prilosec, human fecal material, processed, frozen administered orally
NCT03408886 phase2active not recruitingnot on this mapstarted 2018, after this paper: background citation

Microbiota Transfer Therapy for Adults With Autism Spectrum Disorder (ASD) Who Have Gastrointestinal Disorders

TypeinterventionalSponsorArizona State UniversityRan2018 to 2024Enrolled55ConditionsAutism Spectrum Disorder, Gastrointestinal DisorderArmsVancomycin, MoviPrep, Full Spectrum Microbiota
NCT03426826 phase1unknown statusnot on this mapstarted 2019, after this paper: background citation

Dynamics of Gut Microbiomes in Autism Spectrum Disorder (ASD) Symptoms

TypeinterventionalSponsorChildren's Hospital Los AngelesRan2019 to 2026Enrolled10ConditionsAutism Spectrum Disorder (ASD), Gastro-Intestinal DisorderArmsFMT versus placebo
NCT05967871 phase1recruitingnot on this mapstarted 2024, after this paper: background citation

Pilot Feasibility Study of Fecal Microbiota Transplant for the Treatment of Small Intestinal Bacterial Overgrowth

TypeinterventionalSponsorMcMaster Children's HospitalRan2024 to 2026Enrolled20ConditionsSmall Intestinal Bacterial OvergrowthArmsFecal Microbiota Transplant
NCT06290258 phase1 / phase2recruitingnot on this mapstarted 2024, after this paper: background citation

Fecal Microbiota Transplantation for Gastrointestinal, Autistic, Emotion, and Behavior Symptoms of Patients With Autism Spectrum Disorder and Gastrointestinal Problems: a Preliminary Study.

TypeinterventionalSponsorChang Gung Memorial HospitalRan2024 to 2027Enrolled60ConditionsAutism Spectrum Disorder, Gastrointestinal Diseases, HealthyArmsFecal microbiota transplantation
NCT06609980 phase1recruitingnot on this mapstarted 2024, after this paper: background citation

Fecal Microbiota Transplantation (Autologous) in Infants Treated With Antibiotics

TypeinterventionalSponsorRutgers, The State University of New JerseyRan2024 to 2028Enrolled100ConditionsAntibiotic TreatmentArmsautologous fecal matter transplant
NCT07381374 narecruitingnot on this mapstarted 2026, after this paper: background citation

Study Protocol for a Randomized Controlled of Fecal Microbiota Transplantation Via Different Routes in Children With Moderate-to-Severe Autism Spectrum Disorder

TypeinterventionalSponsorShenzhen Children's HospitalRan2026 to 2027Enrolled1ConditionsAutism Spectrum DisorderArmsctive FMT via Nasojejunal Tube (FMT-Upper GI), Active FMT via Colonoscopy and Transendoscopic Tube (FMT-Lower GI), Placebo via Sham Procedures (Sham-Control)
NCT07450443 phase2 / phase3recruitingnot on this mapstarted 2023, after this paper: background citation

Role of the Gut Vascular Barrier and Microbiota in Autism Spectrum Disorders: Evaluation of Efficacy of Postbiotic-based Nutraceutical Treatment

TypeinterventionalSponsorFondazione I.R.C.C.S. Istituto Neurologico Carlo BestaRan2023 to 2027Enrolled90ConditionsAutism, Autism Disorder, Autism Spectrum Disorder (ASD)ArmsPostbiotiX Comfort®, Control
NCT07490054 phase1recruitingnot on this mapstarted 2025, after this paper: background citation

An Open-Label, Pilot Clinical Trial To Test The Safety And Feasibility Of Intestinal Microbiota Transplantation In Patients With Chronic Heart Failure

TypeinterventionalSponsorMelana Yuzefpolskaya, MDRan2025 to 2027Enrolled40ConditionsChronic Heart FailureArmsMTP-101-C encapsulated Microbiota, Vancomycin, Neomycin
NCT07546942 phase1 / phase2enrolling by invitationnot on this mapstarted 2026, after this paper: background citation

Autism Spectral Disorder (ASD) In Adolescent-Adults Treated by Multimodal Protocol: IV Autologous cSVF, Interval IV Autologous MSCs (Cryopreserved), Strick Ketogenic Diet RESET Program, and Fecal Microbiota Transplantation (FMT)

TypeinterventionalSponsorBlack Tie Medical, Inc.Ran2026 to 2030Enrolled50ConditionsAutism Spectrum Disorder, Autism, Autism Spectral DisorderArmsAutologous MSC isolation, concentration, and cryopreservation of adult mesenchymal stem cells, Fecal Biomicrome Transplantation (FMT), Ketogenic RESET Diet Protocol, Trial combines use of cSVF and MSCs (cryopres) with diet modification and FMT (fecal material Transplant in adult ASD patients, FMT (Fecal Material Tranplantation)
NCT07646808 not yet recruitingnot on this mapstarted 2026, after this paper: background citation

Association Between Gut Microbiome Characteristics and Neurodevelopmental Functioning in Children With Autism Spectrum Disorder: A Multidomain Investigation of the Gut-Motor Axis

TypeobservationalSponsorSaveetha UniversityRan2026 to 2026Enrolled600ConditionsAutism Spectrum Disorder
NCT07756255 phase2not yet recruitingnot on this mapstarted 2026, after this paper: background citation

Feasibility, Safety and Tolerability of Fecal Microbiota Transplantation in an Adolescent Population With Attention Deficit Hyperactivity Disorder (ADHD)

TypeinterventionalSponsorUniversity of CalgaryRan2026 to 2029Enrolled64ConditionsADHD, ADHD - Attention Deficit Disorder With Hyperactivity, ADHD - Combined TypeArmsFecal Microbiota Transplant (FMT), Nitazoxanide 500mg BID, Vancomycin 250mg BID, Placebo Vancomycin, Placebo Nitazoxanide
3 · Its place in the literature

Who cites it

741 citing papers in PubMed, 13 syntheses or guidelines pooled it, 1,333 citations in OpenAlex.

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  13. Indoxyl Sulfate and Autism Spectrum Disorder: A Literature Review.International journal of molecular sciences · 2024
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681 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors at 6 institutions in 2 countries.

Dae-Wook KangBiodesign Swette Center for Environmental Biotechnology, Arizona State University, Tempe, AZ, 85287, USA.
James B AdamsSchool for Engineering of Matter, Transport and Energy, Arizona State University, Tempe, AZ, 85287, USA.
Ann C GregorySoil, Water and Environmental Sciences, University of Arizona, Tucson, AZ, 85721, USA.
Thomas BorodyCentre for Digestive Diseases, Five Dock, NSW, 2046, Australia.
Lauren ChittickDepartment of Ecology and Evolutionary Biology, University of Arizona, Tucson, AZ, 85287, USA.
Alessio FasanoMucosal Immunology and Biology Research Center, Massachusetts General Hospital for Children, Boston, MA, 02114, USA.
Alexander KhorutsDivision of Gastroenterology, Department of Medicine, University of Minnesota, Minneapolis, MN, 55455, USA.
Elizabeth GeisSchool for Engineering of Matter, Transport and Energy, Arizona State University, Tempe, AZ, 85287, USA.
Juan MaldonadoBiodesign Swette Center for Environmental Biotechnology, Arizona State University, Tempe, AZ, 85287, USA.
Sharon McDonough-MeansIntegrative Developmental Pediatrics, Tucson, AZ, 85701, USA.
Elena L PollardSchool for Engineering of Matter, Transport and Energy, Arizona State University, Tempe, AZ, 85287, USA.
Simon RouxDepartment of Ecology and Evolutionary Biology, University of Arizona, Tucson, AZ, 85287, USA.
Michael J SadowskyBioTechnology Institute, University of Minnesota, St. Paul, MN, 55108, USA.
Karen Schwarzberg LipsonPathogen and Microbiome Institute, Northern Arizona University, Flagstaff, AZ, 86011, USA.
Matthew B SullivanSoil, Water and Environmental Sciences, University of Arizona, Tucson, AZ, 85721, USA. mbsulli@gmail.com.
J Gregory CaporasoPathogen and Microbiome Institute, Northern Arizona University, Flagstaff, AZ, 86011, USA. gregcaporaso@gmail.com.
Rosa Krajmalnik-BrownBiodesign Swette Center for Environmental Biotechnology, Arizona State University, Tempe, AZ, 85287, USA. Dr.Rosy@asu.edu.ORCID 0000-0001-6064-3524
Arizona State University · USUniversity of Arizona · USNorthern Arizona University · USUniversity of Minnesota · USCentre For Digestive Diseases · AUMassachusetts General Hospital · US

Funding

Interdisciplinary Program in Microbe-Host BiologyT32AI112542 · NIAID · OHIO STATE UNIVERSITY · PI JUSTICE, SHERYL S, WOZNIAK, DANIEL J · 2014 to 2018
$644k
NIAID NIH HHS T32 AI112542
6 · The paper itself

Abstract

backgroundAutism spectrum disorders (ASD) are complex neurobiological disorders that impair social interactions and communication and lead to restricted, repetitive, and stereotyped patterns of behavior, interests, and activities. The causes of these disorders remain poorly understood, but gut microbiota, the 10

resultsMTT involved a 2-week antibiotic treatment, a bowel cleanse, and then an extended fecal microbiota transplant (FMT) using a high initial dose followed by daily and lower maintenance doses for 7-8 weeks. The Gastrointestinal Symptom Rating Scale revealed an approximately 80% reduction of GI symptoms at the end of treatment, including significant improvements in symptoms of constipation, diarrhea, indigestion, and abdominal pain. Improvements persisted 8 weeks after treatment. Similarly, clinical assessments showed that behavioral ASD symptoms improved significantly and remained improved 8 weeks after treatment ended. Bacterial and phagedeep sequencing analyses revealed successful partial engraftment of donor microbiota and beneficial changes in the gut environment. Specifically, overall bacterial diversity and the abundance of Bifidobacterium, Prevotella, and Desulfovibrio among other taxa increased following MTT, and these changes persisted after treatment stopped (followed for 8 weeks).

conclusionsThis exploratory, extended-duration treatment protocol thus appears to be a promising approach to alter the gut microbiome and virome and improve GI and behavioral symptoms of ASD. Improvements in GI symptoms, ASD symptoms, and the microbiome all persisted for at least 8 weeks after treatment ended, suggesting a long-term impact.

trial registrationThis trial was registered on the ClinicalTrials.gov, with the registration number  NCT02504554.

Indexed as

Fecal Microbiota TransplantationGastrointestinal MicrobiomeAbdominal PainAdolescentAnti-Bacterial AgentsAutism Spectrum DisorderBacteriophagesBifidobacteriumChildConstipationDesulfovibrioDiarrheaDNA, ViralFemaleGastrointestinal DiseasesGastrointestinal TractAnti-Bacterial AgentsDNA, ViralAutism spectrum disorders (ASD)Clinical trialFecal microbiota transplant (FMT)Gut bacteriaGut bacteriophageMicrobiomeVirome

Identifiers

PMID28122648
PMCPMC5264285
OpenAlexW2581406049

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

and 6 more above

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.