Intervention pilot trial for suppression of colibactin-producing E. coli implicated in colorectal carcinogenesis

Not Applicable

• Conditions: colorectal neoplasia(endoscopically removed); Colon tumor

• Registration Number: JPRN-jRCTs051190073
• Lead Sponsor: Ishikawa Hideki

Brief Summary

This study suggested that colibactin-producing bacteria could increased by intake of lactic acid bacteria for 3 months in the fifties to seventies. But it was unclear that the amount of colibactin-producing bacteria could increase during a longer period . However, it is possible that only the increase in the number of bacteria in the twenties to forties was considered. It is necessary to examine this by the intervention test in the longer term.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-13
• Study Completion: 2020-09-10
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

1) Patients with a history of colorectal tumor. 2) Those who are positive for colibactin producing bacteria twice consecutively. 3) Men and women over the age of 20 on the date of registration. 4) Written consent has been obtained by the patient prior to enrollment in the study.

Exclusion Criteria

1) Drug allergy to lactic acid bacteria preparations. 2) Currently taking violactis. 3) Taking antibiotics. 4) For other safety reasons, the principal investigator determines that participation in this study is inappropriate.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Detection of colibactin-producing bacteria 90 days after the start of the intervention.

Secondary Outcome Measures

Name	Time	Method
The presence or absence of detection of colibactin-producing bacteria in the stool 45 days after the start of administration, and evaluation of the amount of colibactin-producing bacteria over the entire period.