臨床研究等提出・公開システム

Date of registration	July. 06, 2026
Last modified on	July. 06, 2026
Trial ID	jRCT2031260282

Scientific Title	A Multi-center, Double-Blind, Randomized, Two-Arm, Parallel-Group, Placebo Controlled Study to Assess the Efficacy and Safety of ELGN-2112 on Intestinal Malabsorption in Preterm Infants (FIT-PIV)
Public Title	A study to evaluate the efficacy and safety of ELGN-2112 on intestinal malabsorption in preterm infants as compared to placebo. (FIT-PIV)

Contact for Scientific Queries	Name	Yasumi Yuya
	Affiliation	MEDISCIENCE PLANNING INC.
	Address	2-27-1, Shinkawa, Chuo-ku, Tokyo
	Telephone	+81-3-5544-8164
	E-mail	yuya.yasumi@mpi-cro.jp
Contact for Public Queries	Name	Yasumi Yuya
	Affiliation	MEDISCIENCE PLANNING INC.
	Address	2-27-1, Shinkawa, Chuo-ku, Tokyo
	Telephone	+81-3-5544-8164
	E-mail	yuya.yasumi@mpi-cro.jp

Recruitment status	Pending

Anticipated date of first enrollment		July. 31, 2026
Target sample size		20
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1. Preterm male and female infants born at gestational age 26+0 to 31+6 weeks. 2. Birth weight 500g or more 3. Singleton or twin delivery 4. Up to 5 days after birth (up to 120 hours after birth)
	Exclusion Criteria	1. Infants not dependent on intravenous amino acids/lipids for nutrition 2. Significant congenital malformations 3. Confirmed diagnosis of necrotizing enterocolitis (NEC)
	Age Minimum	26week old over
	Age Maximum	32week old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		Intestinal Malabsorption in Preterm Infants
Intervention(s)		Infants will be treated for up to 28 days with oral administration of ELGN-2112 or placebo, four times per day.
Primary Outcome(s)		Numbers of days to achieve full enteral feeding.

Primary Sponsor	Elgan Pharma Ltd.

Name of Certified Review Board	Tokyo Metropolitan Bokutoh Hospital Institutional Review Board
Address	4-23-15 Kotobashi, Sumida-ku, Tokyo, Japan, Tokyo
Approval Status	Approval
Date of approval	June. 11, 2026

Plan to share IPD	No

Secondary ID(s)	NCT05670951
Issuing Authority	ClinicalTrials.gov

Secondary ID(s)	2024-517101-87-00
Issuing Authority	EU Clinical Trials Register

Countries of Recruitment（Except Japan）	European countries/UK/USA/Israel