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Therapeutic Option for Nintedanib related diArrhea in patients with progressive fibrosing interstitial lung disease a multicenter Clinical triAl

Therapeutic Option for Nintedanib related diArrhea in patients with progressive fibrosing interstitial lung disease a multicenter Clinical triAl - ONACA study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000058712
Enrollment
60
Registered
2025-08-06
Start date
2025-06-30
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 PF-ILD, excluding scleroderma

Interventions

After onset of nintedanib-associated diarrhea, nintedanib dose was reduced (nintedanib 150 mg twice a day in the morning and evening is reduced to 100 mg twice a day). After onset of nintedanib-associ

Sponsors

Shinmatsudo central general Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with PF-ILD, excluding scleroderma 20 to 80 years old at the time consent is obtained Any previous treatment is included Written informed consent is obtained

Exclusion criteria

Exclusion criteria: Those who consume yogurt (including beverages) within 1 week prior to the start of nintedanib Those who already taking MIYA BM or Biofermin before starting nintedanib Patients allergic to digestive medications Those who are deemed by the attending physician to be ineligible for this study

Design outcomes

Primary

MeasureTime frame
Change in diarrhea index in patients with nintedanib-associated diarrhea in the nintedanib dose reduction group and MiyaBM addition group

Countries

Japan

Contacts

Public ContactKazuko Tanaka

Shinmatsudo central general Hospital Pulmonary medicine

kazuko.m.tanaka@gmail.com0473451111

Outcome results

None listed

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