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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs051190073
Enrollment
15
Registered
2019-11-13
Start date
2019-12-10
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

colorectal neoplasia(endoscopically removed) Colon tumor

Interventions

Colibactin positive patients are given biolactis (3 g/day) for 3 months.

Sponsors

Ishikawa Hideki
Lead Sponsor
Watanabe Kenji
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Detection of colibactin-producing bacteria 90 days after the start of the intervention.

Secondary

MeasureTime frame
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.

Contacts

Public ContactHideki Ishikawa

Ishikawa Gastorintetinal Clinic

cancer@gol.com+81-6-6202-6566

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026