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The efficacy of bifidobacterium preparation LKM512 for rectal aberrant crypt foci: A double-blind randomized controlled trial

The efficacy of bifidobacterium preparation LKM512 for rectal aberrant crypt foci: A double-blind randomized controlled trial - LKM512 for rectal ACF

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000023899
Enrollment
60
Registered
2016-09-01
Start date
2016-09-01
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

Patients with both resectable colorectal adenoma/carcinoma in situ by colonoscopy and rectal ACF

Interventions

receive oral LKM512 powder 1g per day for 2 month receive oral placebo powder per day for 2 month

Sponsors

Yokohama City Univesity
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Patients with both colorectal ACF and resectable adenoma/cancer. 2.Willingness to provide written informed consent

Exclusion criteria

Exclusion criteria: 1.History of regular use of Lactobacillous, Bifidobacterium preparation supplements. 2.History of regular use (defined as at least once per week) of NSAIDs and/or aspirin. 3.History of heart failure, renal failure, liver cirrhosis or chronic hepatic failure 4.History of familial adenomatous polyposis 5.History of hereditary non-polyposis colorectal cancer 6.History of inflammatory bowel disease 7.Pregnancy or possibility of pregnancy 8.Patients judged as inappropriate candidates for the trial by the investigators

Design outcomes

Primary

MeasureTime frame
The amount of change of rectal ACF

Secondary

MeasureTime frame
The change of microbiota Safety The cell-proliferative and apoptotic activities in the colorectal epithelium and adenoma/cancer

Countries

Japan

Contacts

Public ContactTakuma Higurashi

Yokohama City Univesity Department of Gastroenterology and Hepatology

takuma_h@yokohama-cu.ac.jp045-787-2640

Outcome results

None listed

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