Can a Low-THC cannabis extract calm the sudden psychiatric storm of PANS?

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 1 - 17 years of age * Patients who fulfil PANS criteria * Acute onset of OCD or severely restricted food intake * Concurrent presentation of additional neuropsychiatric symptoms from at least 2 of the following 7 categories: anxiety, emotional lability/depression, irritability, aggression or severely oppositional behaviours, behavioural regression, deterioration in school performance, sensory or motor abnormalities (e.g. tics), somatic symptoms (e.g. sleep disturbances, enuresis or increase in urinary frequency) * Symptoms not better explained by a known neurologic or medical disorder (e.g. Sydenham's chorea) * RCADS-P scores of \>65 (a scale of anxiety, social phobia, panic disorder, OCD, and low mood, a score of \>65 infers moderate-significant impairment) * Other patient medications (e.g. anti-psychotics) must be stable for at least 12 weeks prior to trial participation Exclusion Criteria: * Infection and/or antibiotic use in the 2 weeks prior to trial participation (i.e. baseline blood tests and commencement of NTI164) * Recent changes to other patient medication (e.g. addition or escalation of anxiolytics, anti-depressants etc; medication dosage must be stable for at least 12 weeks prior to trial participation) * Intellectual disability preventing adequate assent from patient, or that would affect reporting throughout trial; patients with intellectual disability must still have the capacity to verbalise their symptoms/experiences * Ongoing immunomodulating or immunosuppressive treatment use in the previous 12 weeks, including steroids, IVIG, antibiotics, low-dose naltrexone, mycophenolate, Rituximab etc. * Currently using or has used recreational or medicinal cannabis or cannabinoid-based medications (e.g. Sativex ®, Epidiolex ®) in the previous 12 weeks and/or is unwilling or unable to abstain for the duration of the trial * Underlying renal impairment, cardiovascular issues (e.g. arrhythmia), current or previous thrombosis * Impaired hepatic function, defined as serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2 x upper limit of normal (ULN) or total bilirubin (TBL) \> 2 x ULN; this criterion can only be confirmed once baseline laboratory results are available and participants who fail this criterion will not proceed in this study * Other diagnosed neurological condition likely to be contributing to OCD/neuropsychiatric symptoms (e.g. Huntington's disease)