Prenatal Administration of Spermine Promotes Maturation of Premature Fetal Gut Epithelial Tight Junction: Experimental Study on Fetal Rabbit

Prenatal Administration of Oral Spermine Promotes Maturation of Premature Fetal Gut Epithelial Tight Junction: Experimental Study on Oryctolagus Cuniculus

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04004091

Enrollment

Registered

2019-07-01

Start date

2019-03-01

Completion date

2019-09-30

Last updated

2020-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NEC, Premature Birth

Keywords

Premature Birth, Spermine, Necrotizing Enterocolitis, Tight Junction

Brief summary

Infections, particularly on the gastrointestinal tract, has been known to be one of the leading causes of death in preterm infants. This is due to the immaturity of the intestinal epithelial cells. Recent studies have shown that polyamines have a role on the development of cells during embryonal phase. By this experimental study, the investigators would like to evaluate the administration of spermine on the maturation of premature fetal gut epithelial tight junction.

Detailed description

This experimental study is conducted with minimum 24 subjects which divided into 6 groups; 1) 24-days pregnant and is given prenatal spermine, 2) 26-days pregnant and is given prenatal spermine, 3) 28-days pregnant and is given prenatal spermine, 4) 24-days pregnant and is not given prenatal spermine, 5) 26-days pregnant and is not given prenatal spermine, and 6) 28-days pregnant and is not given prenatal spermine. At the end of desired pregnancy period, hysterectomy is done and fetus are born. From each parent subject, three fetal samples are chosen using a random sampling. Intestinal tissues are taken from each fetal sample to be examined. Several data will be collected i.e. occludin, β-catenin, and β-actin, as well as histological morphologies.

Interventions

BIOLOGICALSpermine

Spermine is a polyamine. It is an organic molecule that is involved in cellular metabolism and development.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

24 Days to 28 Days

Healthy volunteers

Yes

Inclusion criteria

* Intestinal tissue of fetal rabbit that is prematurely alive

Exclusion criteria

* Intestinal tissue of fetal rabbit that is dead before termination * Intestinal tissue of fetal rabbit, in which the parent died before termination

Design outcomes

Primary

Measure	Time frame	Description
Occludin	2 weeks	Measurement of occludin (ng/mg protein) from intestinal tissue sample is assessed using Rabbit Occludin ELISA Kit
β-catenin	2 weeks	Measurement of β-catenin (pg/mg protein) from intestinal tissue sample is assessed using Rabbit β-Catenin ELISA Kit
β-actin	2 weeks	Measurement of β-actin (ng/mg protein) from intestinal tissue sample is assessed using β-Actin ELISA Kit

Secondary

Measure	Time frame	Description
Histologic Findings	2 weeks	Identifying the development of epithelial tight junction cells based on the morphologic findings of the villi structure, including Goblet cells' distribution, enterocytes, enteroendocrine cells, and crypts.

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026