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Table 1 Study schedule of enrollment, interventions, and assessments

From: Probiotics and oxytocin nasal spray as neuro-social-behavioral interventions for patients with autism spectrum disorders: a pilot randomized controlled trial protocol

 

Study period

Screening

Baseline

Follow-up

Post-trial

Visit

 

1

2

3

Time point

 

Day 0

Week 12

Week 24

Week 36

Enrollment

     

 Eligibility screening

X

    

 Written informed consent

 

X

   

 Randomization and allocation (after eligibility criteria met and written informed consent obtained)

 

X

   

Interventions

     

 First stage: L. reuteri vs placebo

  

X

  

 Second stage: L. reteri plus OXT spray vs placebo plus OXT spray

   

X

 

Assessments

     

 Past medical history and medications

X

    

 Surveys (ABC, SRS-2, GSI, and microbiome)

 

X

X

X

 

 Labs (OXT and fecal microbiome)

 

X

X

X

 

 Tests (emotion matching and eye-tracking)

 

X

X

X

 

 Adverse events

  

X

X

X

  1. OXT oxytocin, ABC Aberrant Behavior Checklist, SRS social responsiveness scale, GSI gastrointestinal severity index, GABA gamma-aminobutyric acid, IL interleukin, TGF tumor growth factor, IFN interferon, GFAP glial fibrillary acidic protein, MBP myelin basic protein, TNF tumor necrosis factor, fMRI functional magnetic resonance imaging, L. reuteri Lactobacillus reuteri