Probiotics trial

JRCT ID: jRCTs031200395

Registered date:04/03/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Aspirin-induced small bowel injuries
• Date of first enrollment: 06/04/2021
• Target sample size: 60
• Study type: Interventional
• Intervention(s): Probiotics (Lactobacillus gasseri/OLL2716) are administered for 6 weeks to the control group, the proton pump inhibitor oral administration group, and the aspirin and proton pump inhibitor oral administration group.

Outcome(s)

• Primary Outcome: Intestinal bacterial profile in the stool

Secondary Outcome

1)Tight junction damage
2)COX expression
3)Amounts of mucosal prostaglandins
4)Existence ratio of immune cells
5)Intestinal bacterial profile (wash, biopsy tissue)
6)Amounts of calprotectin in the stool

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Older than 20 y.o.
2) Patients who plan to have a colonoscopy
3) Patients who gave written informed consent before entry in this study

Exclude criteria

1) Patients who received antibiotics within 6 months before registration
2) Patients who regularly use other lactic acid bacteria preparations
3) Patients allergic to dairy products
4) A person who is determined to be inappropriate by the research director or co-workers

Related Information

• Primary Sponsor: Suzuki Takayoshi
• Source(s) of Monetary Support: Meiji Co.,Ltd.,Japan Society for the Promotion of Science