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Table 2 Data collection

From: Evaluating the effect of prebiotics on the gut microbiome profile and β cell function in youth with newly diagnosed type 1 diabetes: protocol of a pilot randomized controlled trial

Study phase

Screening visit

Baseline- intervention

Washout

Crossover- intervention

Follow-up

Early termination visit

Visit window

 

<30 days after Visit 1

+/ − 3 days 28 days after Visit 2

+/ − 3 days 28 days after Visit 3

+/ − 3 days 28 days after Visit 4

 

Informed consent/assent

X

     

Inclusion/exclusion criteria

X

     

Historical data/demographics

X

     

Random C-peptide concentration

X

 

X

   

Randomization

 

X

    

Pregnancy test for females of childbearing age

X

X

X

X

X

X

Current medical data

X

X

X

X

X

X

Pubertal Tanner staging with physical exam

X

   

X

X

Ht/Wt measurement and vitals

X

X

X

X

X

X

Supervised CGM insertion (and training, if applicable, on use)

 

X

 

X

  

C-peptide by 2-h MMTT

  

X

 

X

X

HbA1c

 

X

  

X

X

Blood samples for biomarkers (PI:C and INS DNA)

 

X

X

X

X

X

Provision of HAMS-AB

 

X

 

X

  

CGM download

  

X

 

X

X

Stool samples

 

X

X

X

X

X

PBMCs for MAIT cell testing

 

X

X

X

X

X

Serum and plasma for storage

 

X

X

X

X

X

Adverse event assessment

 

X

X

X

X

X

Online dietary assessments

 

X

X

X

X

X

Verbal diet recall

X

     

Sampling of prebiotic

X

     
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Pilot and Feasibility Studies

ISSN: 2055-5784