Table 1.

Study and follow-up schedule

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

¹Visit window: 0 days for visit 1; ± 2 days for visits 2, 3, and 4

²Medical history: current and past illnesses, including peptic ulcer, gastritis, oesophagitis, cardiovascular and cerebrovascular diseases, cancer, and mental illness

³Medication history: PPI, histamine H2 antagonists, antibiotics, probiotics, prokinetics, gastric mucosal protectors, and other drugs for gastro-oesophageal reflux (including herbs)

⁴Surgical history: gastrointestinal surgeries, including gastro-oesophageal and duodenal surgeries

⁵Performance of gastroscopy in domestic tertiary or higher hospitals in the past 3 months

⁶Gastroscopy at visit 4, LA grades at visit 0 and visit 4 referring to patients with oesophagitis (LA-A, LA-B or LA-C)

⁷Abdominal ultrasound B: to examine the abdominal organs to screen for upper abdominal malignancies

⁸Liver and kidney tests: ALT, AST, total bilirubin, blood urea nitrogen, Scr

Weight and height will be measured in the morning

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

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