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

JRCT ID: jRCTs031220119

Registered date:07/06/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: interstitial lung disease
• Date of first enrollment: 07/06/2022
• Target sample size: 3
• Study type: Interventional
• 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.

Outcome(s)

• Primary Outcome: No 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 maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Abe Mitsuhiro
• Source(s) of Monetary Support: Clinical Research Initiation-Fund(of Chiba University Hospital)