臨床研究等提出・公開システム

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Date of registration	June. 07, 2022
Last modified on	June. 07, 2022
Trial ID	jRCTs031220119

Scientific Title	Tolerability of oral nutrition supplementation for interstitial lung disease with a tendency toward weight loss
Public Title	Tolerability of oral nutrition for interstitial lung disease with weight loss tendency

Contact for Scientific Queries	Name	Abe Mitsuhiro
	Affiliation	Chiba University Hospital
	Address	1-8-1,Inohana,Chuo-ku,Chiba-City,Chiba,Japan
	Telephone	+81-432227171
	E-mail	mthrsgnm@chiba-u.jp
Contact for Public Queries	Name	Abe Mitsuhiro
	Affiliation	Chiba University Hospital
	Address	1-8-1,Inohana,Chuo-ku,Chiba-City,Chiba,Japan
	Telephone	+81-43-222-7171
	E-mail	mthrsgnm@chiba-u.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		June. 07, 2022
Actual date of first enrollment
Target sample size		3
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1) 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.
	Exclusion Criteria	1) 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.
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		interstitial lung disease
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.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		No incidence of dose-limiting toxicity over 28 days.
Secondary Outcome(s)		(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.

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support	Clinical Research Initiation-Fund(of Chiba University Hospital)
Secondary Sponsor	Not applicable

Name of Certified Review Board	Name of Certified Review Board Chiba University Certified Clinical Research Review Board
Address	1-8-1, Inohana, Chuo-ku, Chiba-City, Chiba, Japan, Chiba
Telephone	+81-43-222-7171
E-Mail	prc-jim@chiba-u.jp
Approval Status	Approval
Date of approval

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none