Skip to main content

Table 1 Study schedule for the participants in the pilot randomized controlled trial of fecal microbiota transplantation (FMT) treatment of bipolar depression

From: The safety and efficacy of fecal microbiota transplantation in a population with bipolar disorder during depressive episodes: study protocol for a pilot randomized controlled trial

Measure

Study period

Purpose

Prior to intervention

Intervention

Follow-up (12 visits every 2 weeks)

Screening

Baseline

Colonoscopy visit

Every 2 weeks

Week 12 and week 24 visits

Eligibility screening

X

    

Feasibility

Informed consent

X

    

Feasibility

Confirmation of eligibility

 

X

   

Feasibility

Randomization

 

X

   

Feasibility

Colonoscopy

  

X

  

Intervention

Anthropometric measurements

 

X

 

X

 

Covariates

Food diary

 

X

  

X

Covariates

Mucosa biopsies/colon secretion

  

X

  

Microbial analysis

Stool sample

 

X

  

X

Microbial analysis

Blood sample

  

X

  

Safety

Concomitant medications

X

X

X

X

 

Safety

Symptoms diary

   

X

 

Safety/tolerance

Toronto Side Effect Scale (TSES)

 

X

 

X

 

Safety/efficacy

Mini-International Neuropsychiatric Interview (MINI)

X

    

Feasibility

Young Mania Rating Scale (YMRS)

X

X

 

X

 

Efficacy

Montgomery–Asberg Depression Rating Scale (MADRS)

X

X

 

X

 

Efficacy

State and Trait Anxiety Inventory (STAI)

 

X

 

X

 

Efficacy

Sheehan Disability Scale (SDS)

 

X

 

X

 

Efficacy

World Health Organization Quality of Life (WHOQOL-BREF)

 

X

 

X

 

Efficacy