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Table 1 Study and follow-up schedule

From: Protocol of a randomized, double-blind, placebo-controlled study of the effect of probiotics on the gut microbiome of patients with gastro-oesophageal reflux disease treated with rabeprazole

Item1,10

Screening

Baseline

Initial treatment

Maintenance treatment

Visit 0

Visit 1

Visit 2

Visit 3

Visit 4

Days −3 to 0

Day 0

Week 4

Week 8

Week 12

Basic demographics

X

    

Vital signs, physical examination

X

    

Allergies, medical history2, medication history3, surgical history4

X

    

Smoking and drinking

X

    

Gastroscopy

X5

   

X6

Abdominal ultrasound B7

X

    

Serum human chorionic gonadotropin (hCG)

X

    

ECG

X

   

X

Blood test, urine analysis, stool test (including occult blood)

X

   

X

Liver/kidney function8

X

   

X

Signed informed consent

X

    

Inclusion/exclusion criteria verification

 

X

   

Primary outcome measure

GM11 (metagenomics)

X

 

X

X

X

Secondary outcome measures

RDQ

X

X

X

X

X

GSRS

 

X

X

X

X

Faecal metabolomics11

X

 

X

X

X

BMI 9

 

X

X

X

X

LA grade

X

   

X

Safety measures

AEs

  

X

X

X

SAEs

  

X

X

X

Compliance verification

 

X

X

X

 

Concomitant medications

X

X

X

X

 
  1. 1Visit window: 0 days for visit 1; ± 2 days for visits 2, 3, and 4
  2. 2Medical history: current and past illnesses, including peptic ulcer, gastritis, oesophagitis, cardiovascular and cerebrovascular diseases, cancer, and mental illness
  3. 3Medication history: PPI, histamine H2 antagonists, antibiotics, probiotics, prokinetics, gastric mucosal protectors, and other drugs for gastro-oesophageal reflux (including herbs)
  4. 4Surgical history: gastrointestinal surgeries, including gastro-oesophageal and duodenal surgeries
  5. 5Performance of gastroscopy in domestic tertiary or higher hospitals in the past 3 months
  6. 6Gastroscopy at visit 4, LA grades at visit 0 and visit 4 referring to patients with oesophagitis (LA-A, LA-B or LA-C)
  7. 7Abdominal ultrasound B: to examine the abdominal organs to screen for upper abdominal malignancies
  8. 8Liver and kidney tests: ALT, AST, total bilirubin, blood urea nitrogen, Scr
  9. Weight and height will be measured in the morning
  10. 10For the abdominal B-ultrasound and ECG evaluations performed at visit 0, examination results from the past 3 months are acceptable; examination results from the past 1 week are acceptable for blood HCG, blood, routine urine and stool (including occult blood) tests, and liver/kidney function tests
  11. 11The detection of GM will be conducted within 2 months after the end of the follow-ups, and the detection of FM will be performed within 2 months of when data analysis determines that the probiotics have a significant effect on GM