Gastric microbiota eradication for intestinal metaplasia

JRCT ID: jRCTs031230207

Registered date:05/07/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: intestinal metaplasia
• Date of first enrollment: 12/07/2023
• Target sample size: 33
• Study type: Interventional
• Intervention(s): After registration, a biopsy will be performed by upper gastrointestinal endoscopy (within 30 days of registration), and if the histological intestinal metaplasia score in the gastric fundus is 2 or higher, treatment will begin (within 30 days of upper gastrointestinal endoscopy). The investigational treatment consists of a 7-day oral administration of vonoprazan 20 mg twice daily (40 mg/day), metronidazole 250 mg twice daily (500 mg/day), and sitafloxacin 100 mg twice daily (200 mg/day). A second upper gastrointestinal endoscopy with biopsy will be performed 1 year +- 3 months after the first one, and the results will be explained (within 30 days of upper gastrointestinal endoscopy).

Outcome(s)

Primary Outcome

Improvement rate of histological intestinal metaplasia in gastric antrum
Definition: In this study, patients with two or more score of intestinal metaplasia score (updated sydney system) in gastric corpus are intervened. After the intervention with berberine group or control group, patients with one or less the score defined as improved. Primary outcome is improvement rate.

Secondary Outcome

1.Changes in the composition of gastric microbiota before and after intervention, as well as changes in the occupancy ratio of the constituent bacteria.
2.Change in the histological intestinal metaplasia (body) score before and after intervention.
3.Change in the histological intestinal metaplasia (gastric angle) score before and after intervention.
4.Change in the histological chronic inflammation (antrum) score before and after intervention.
5.Change in the histological chronic inflammation (body) score before and after intervention.
6.Change in the histological chronic inflammation (gastric angle) score before and after intervention.
7.Change in the histological acute inflammation (antrum) score before and after intervention.
8.Change in the histological acute inflammation (body) score before and after intervention.
9.Change in the histological acute inflammation (gastric angle) score before and after intervention.
10.Change in the histological atrophy (antrum) score before and after intervention.
11.Change in the histological atrophy (body) score before and after intervention.
12.Change in the histological atrophy (gastric angle) score before and after intervention.
13.Change in the "Endoscopic findings score for gastric cancer risk" before and after intervention.
14.Change in the endoscopic intestinal metaplasia score before and after intervention.
15.Change in the endoscopic atrophy score before and after intervention.
16.Change in the endoscopic diffuse reddening score before and after intervention.
17.Change in the endoscopic fold thickening score before and after intervention.
18.Change in the endoscopic nodular gastritis score before and after intervention.
19.Change in the expression of the intestinal metaplasia-related marker CDX2 before and after intervention.
20.Change in the expression of the intestinal metaplasia-related marker ISX before and after intervention.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Individuals who are considered to have endoscopically suspected intestinal metaplasia based on an endoscopic examination within the past 3 months to 1 year
2. Individuals who are clinically evaluated as having successfully eradicated H. pylori after eradication therapy or as not currently infected with H. pylori
3. Individuals who can undergo upper gastrointestinal endoscopy and biopsy before the trial treatment, and upper gastrointestinal endoscopy and biopsy 1 year +- 3 months after the trial treatment

Exclude criteria

(1) Individuals who are taking anticoagulants (warfarin potassium, edoxaban, dabigatran, rivaroxaban, apixaban)
(2) Individuals who are taking antiplatelet drugs (aspirin, ticlopidine, clopidogrel, cilostazol, ethyl icosapentate, prasugrel
(3) Individuals who are pregnant or may be pregnant
(4) Individuals who are in the lactation period
(5) Individuals with a history of allergy to vonoprazan, metronidazole, or sitafloxacin
(6) Individuals who have received Helicobacter pylori eradication therapy with vonoprazan, metronidazole, and sitafloxacin in the past
(7) Individuals who are receiving atazanavir sulfate or lopinavir hydrochloride
(8) Individuals with organic disorders of the brain or spinal cord.

Related Information

• Primary Sponsor: Sue Soichiro
• Source(s) of Monetary Support: Yokohama City University