The efficacy of azithromycin for the treatment of nonalcoholic steatohepatitis accompanied with Porphyromonas.gingivalis infection in the liver-Randomized controlled trial

The efficacy of azithromycin for the treatment of nonalcoholic steatohepatitis accompanied with Porphyromonas.gingivalis infection in the liver-Randomized controlled trial - The efficacy of azithromycin for the treatment of nonalcoholic steatohepatitis accompanied with Porphyromonas.gingivalis infection in the liver-Randomized controlled trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000009265

Enrollment

Registered

2012-11-10

Start date

2012-11-10

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

nonalcoholic fatty liver disease/nonalcoholic steatohepatitis

Interventions

medical drug placebo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1, NAFLD/NASH with P.gingivalis infection in the liver 2, Patients between 20 years old and older than that, and age less than 80 years old. 3, Patients who agreed to participate in this study.

Exclusion criteria

Exclusion criteria: 1, Patients with alcoholic liver diseases. 2,Patients with viral liver diseases, autoimmune hepatitis, and primary biliary cirrhosis. 3, Paitents with pregnancy. 4, Patients who have allergy against ingredients of azithromicin. 5, Patients who have allergy against other macrolides and ketolides. 6, Patients with liver cirrhosis,liver failure including severe liver function test, hepatocellular carcinoma in the liver and other organs. 7, Patients with severe heart diseases. 8, Patients with hereditary fructose intolerance, glucose-galactose malabsorption, and sucrase-isomaltase deficiency. 9, Medical doctors decided the patients inappropriate.

Design outcomes

Primary

Measure	Time frame
improvement of liver function test	—

Secondary

Measure	Time frame
improvement of histological findings of the liver	—

Countries

Japan

Contacts

Public ContactHideyuki Hyogo

Hiroshima University Hospital Gastroenterology and Metabolism

hidehyogo@hiroshima-u.ac.jp

Outcome results

None listed

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