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

JRCT ID: jRCTs051190073

Registered date:13/11/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: colorectal neoplasia(endoscopically removed)
• Date of first enrollment: 10/12/2019
• Target sample size: 15
• Study type: Interventional
• Intervention(s): Colibactin positive patients are given biolactis (3 g/day) for 3 months.

Outcome(s)

• Primary Outcome: Detection of colibactin-producing bacteria 90 days after the start of the intervention.
• Secondary Outcome: 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.

Key inclusion & exclusion criteria

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

Related Information

• Primary Sponsor: Ishikawa Hideki
• Secondary Sponsor: Watanabe Kenji
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development