The efficacy of additional metformin to aspirin for human rectal aberrant crypt foci: double-blinded randomized controlled trial

The efficacy of additional metformin to aspirin for human rectal aberrant crypt foci: double-blinded randomized controlled trial - The efficacy of aspirin and metformin for rectal ACF

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs031180253

Enrollment

Registered

2019-03-13

Start date

2017-09-08

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 adenoma, carcinoma in situ Colorectal Neoplasm

Interventions

medication

aspirin metformin

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients both with rectal ACF and resectable polyps

Exclusion criteria

Exclusion criteria: 1. Patients with lesion which preferred early resection. 2. History of regular use (defined as at least once per week) of NSAIDs and/or aspirin. 3. History of regular use of warfarin and/or DOAC. 4. History of diabetes mellitus (defined as more than HbA1c 6.5% or regular use of anti-diabetic drugs). 5.History of heart failure, renal failure, liver cirrhosis or chronic hepatic failure 6.History of familial adenomatous polyposis, hereditary non-polyposis colorectal cancer and inflammatory bowel disease

Design outcomes

Primary

Measure	Time frame
The amount of change rectal ACF in aspirin plus placebo group and aspirin plus metformin group after 8weeks intervention	—

Secondary

Measure	Time frame
The number of rectal ACF before and after intervention in both group Ki67 labeling index of colorectal adenoma/cancer and normal mucosa before and after intervention Safety	—

Contacts

Public ContactNoboru Misawa

Yokohama City University Hospital

nobomisa@hotmail.co.jp+81-45-787-2640

Outcome results

None listed

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