Effect of Probiotics on gastric inflammation

JRCT ID: jRCTs031220708

Registered date:16/03/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Sever atrophic gastritis after Hp eradicaiton
• Date of first enrollment: 16/03/2023
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Probiotics (Lactobachillus gasseri/OLL2716) are administered for 6 months after 2nd upper endoscopy

Outcome(s)

• Primary Outcome: Degree of improvement in gastric mucosal inflammation findings before and after taking probiotics, obtained at the 2nd and the 4th exam each.

Secondary Outcome

1. Pepsinogen I and Pepsinogen II
2. CRP
3. pH of gastric juice, LPS activity in the stomach
4. gastric flora

Key inclusion & exclusion criteria

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

Include criteria

1. Patient aged 18 years old and older
2. Patients with severe atrophy (O-2 or higher by Kimura/Takemoto classification) or a history of
endoscopic treatment for early differentiated gastric cancer, in which H. pylori was likely involved in
carcinogenesis
3. Patient who had Hp eradication history more than 6 months ago
4. Patient who have been fully informed and have given written consent to participate in this study

Exclude criteria

1.Patient who is Hp positive
2.Patient who underwent gastric surgery
3.Patient who is unable to discontinue acid suppressants or probiotics other than LG21 during the study period
4. Patients with a history of food allergy to dairy products
5. A person who is determined to be inappropriate by the principal investigator or subinvestigator

Related Information

• Primary Sponsor: Suzuki Takayoshi
• Source(s) of Monetary Support: Meiji Co.Ltd.