NIPH Clinical Trials Search

JRCT ID: jRCTs031220119

Registered date:07/06/2022

Tolerability of oral nutrition for interstitial lung disease with weight loss tendency

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedinterstitial lung disease
Date of first enrollment07/06/2022
Target sample size3
Countries of recruitment
Study typeInterventional
Intervention(s)ISOCAL 100 100 ml (1 bottle) per day, taken orally for 28 days (in some cases up to 35 days). The dose may be increased to 200 ml (2 bottles) if tolerated at 14 days.


Primary OutcomeNo incidence of dose-limiting toxicity over 28 days.
Secondary Outcome(a) Secondary efficacy endpoints 1) Change in body weight(kg) at 28 days. 2) Questionnaire assessment of food intake at 28 days. 3) Activity assessment using the Barthel index at 28 days. (b) Secondary safety endpoints 1) All serious adverse events. 2) Adverse events for which a causal relationship to oral nutritional supplementation cannot be ruled out. (c) Secondary endpoints of tolerability Evaluation of ISOCAL 100 by patients.

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
Include criteria1) Patients diagnosed with interstitial lung disease 2) Patients aged 20 years and over at the time of obtaining consent 3) Patients with weight loss of at least 1 kg in the last 12 months 4) Patients who have been fully informed of the study and have obtained documentation of their own free will with full understanding of their participation in the study.
Exclude criteria1) Patients with coexisting malignant disease 2) Patients with other diseases such as diabetes causing weight loss 3) Patients already taking oral nutritional supplements at least once a week 4) Patients receiving new medication within the past month for diarrhea as a side effect of antifibrotic drugs 5) Patients allergic to milk, soya and gelatine, which are ingredients of Isocal 100 6) Patients unable to give consent 7) Other patients deemed unsuitable for the safe conduct of the study by the principal investigator or the sub-investigator.

Related Information


Public contact
Name Mitsuhiro Abe
Address 1-8-1,Inohana,Chuo-ku,Chiba-City,Chiba,Japan Chiba Japan 260-8670
Telephone +81-43-222-7171
Affiliation Chiba University Hospital
Scientific contact
Name Mitsuhiro Abe
Address 1-8-1,Inohana,Chuo-ku,Chiba-City,Chiba,Japan Chiba Japan 2608670
Telephone +81-432227171
Affiliation Chiba University Hospital