Tokyo, Aug. 7 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058712) titled 'Therapeutic Option for Nintedanib related diArrhea in patients with progressive fibrosing interstitial lung disease a multicenter Clinical triAl' on Aug. 6.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Dose comparison
Primary Sponsor:
Institute - Shinmatsudo central general Hospital
Condition:
Condition - Patients with PF-ILD, excluding scleroderma
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Validating the nintedanib dose reduction group versus MiyaBM addition group treating nintedanib-associated diarrhea in patients with PF-ILD, excluding scleroderma, in a randomized comparison using the diarrhea index.
Basic objectives2 - Others
Intervention:
Interventions/Control_1 - 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).
Interventions/Control_2 - After onset of nintedanib-associated diarrhea, MIYA BM (two MIYA BM tablets three times a day after breakfast, lunch and dinner) is added without reducing nintedanib dose.
Eligibility:
Age-lower limit - 20
years-old
Gender - Male and Female
Key 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
Key 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
Target Size - 60
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 06 Month 02 Day
Anticipated trial start date - 2025 Year 06 Month 30 Day
Last follow-up date - 2030 Year 09 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066249
Disclaimer: Curated by HT Syndication.
