Hollander 2020a.

Study characteristics
Methods	Cross‐over trial of Trichuris suis ova versus placebo
Participants	Inclusion criteria: "age 18‐35, inclusive, at the time of consent, Outpatient, meet criteria for the diagnosis of Autism Spectrum Disorder according to the DSM‐4‐TR, and supported by the ADOS or ADI‐R, have an IQ of 70 or greater, participants who are taking other medications prior to enrollment had to be on a stable dose of concomitant medication, including psychotropic, anticonvulsant, or sleep aid for at least 3 months prior to baseline ratings. Other inclusion criteria included being judged reliable for medication compliance and agree to keep appointments for study contacts and tests as outlined in the protocol (both subjects and guardians) and have a personal or family history of allergies". Exclusion criteria History of bipolar or other psychiatric disorders (such as schizophrenia or schizoaffective disorders) Previous diagnosis of Rett's Disorder or Childhood Disintegrative Disorder Uncontrolled seizure disorders (defined as seizures within the past 6 months) Pregnant or breastfeeding at screening or at any time during the study Other chronic medical conditions Treatment in the last 12 weeks with cyclosporine, methotrexate, infliximab or immunomodulatory agents, treatment in the last 2 weeks with antibiotics, antifungal or antiparasitic medications history of previous treatment with Trichuris suis Ova (TSO) Location/setting: autism programme at Montefiore Medical Center, Albert Einstein College of Medicine, USA Sample size: 10 total (cross‐over) Number of withdrawals/ dropouts: none reported Gender: 9 male, 1 female Mean age: 21.15 years IQ: 87.89 Baseline ABC‐I or other BoC: parent‐rated ABC‐I 12.5 Concomitant medications: details not provided History of previous medications: details not provided
Interventions	Intervention (Trichuris suis ova) for 12 weeks: Trichuris suis ova were administered in vials prepared by Coronado Biosciences. Vials were diluted with a commercial drink and given to participants orally to ingest. Participants received a dose of 2500 ova every 2 weeks for 12 weeks. Comparator (placebo) for 12 weeks: placebo was administered on site every 2 weeks.
Outcomes	Primary outcomes: irritability, measured using the ABC‐Irritability subscale (Aman 1985) self‐injurious behaviour, measured using the Repetitive Behaviour Scale Revised (RBS‐R) ‐ Self‐injurious subscale (Bodfish 2000) AEs Secondary outcomes: none reported Timing of outcome assessment: baseline and every 2 weeks for 12 weeks
Notes	Study start date: November 2012 Study end date: June 2014 Source of funding: funding provided by the Simons Foundation. Drug/placebo and consulting provided by Coronado Biosciences: "Coronado Biosciences also provided both TSO and the matching placebo". Conflicts of interest: none declared Trial registry: NCT01040221
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Details not provided
Allocation concealment (selection bias)	Unclear risk	Details not provided
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Details not provided
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Other than "double‐blinded", details not provided
Incomplete outcome data (attrition bias) All outcomes	High risk	No dropouts were reported although only 9 were analysed for CGI scale
Selective reporting (reporting bias)	High risk	The ABC was apparently measured at baseline, 2, 4, 6, 8, 10, 12, 14, 16 weeks. Only pooled baseline and mean change from baseline to endpoint were reported
Other bias	High risk	No study results posted on ClinicalTrials.gov for this study even though it was completed July 2014. Active treatment prepared by pharmaceutical company