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NCT Number: NCT04004091

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

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.

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Key information

Conditions

Premature Birth Digestive System Diseases Enterocolitis Enterocolitis, Necrotizing Female Urogenital Diseases and Pregnancy Complications Gastroenteritis Gastrointestinal Diseases Intestinal Diseases NEC Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Urogenital Diseases

Age range

24 day–28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Dr. Cipto Mangunkusumo National Hospital

Jakarta Pusat, Jakarta Special Capital Region, 10340, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spermine

Biological

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

Primary outcomes

  1. Occludin

    Time frame: 2 weeks

    Measurement of occludin (ng/mg protein) from intestinal tissue sample is assessed using Rabbit Occludin ELISA Kit

  2. β-catenin

    Time frame: 2 weeks

    Measurement of β-catenin (pg/mg protein) from intestinal tissue sample is assessed using Rabbit β-Catenin ELISA Kit

  3. β-actin

    Time frame: 2 weeks

    Measurement of β-actin (ng/mg protein) from intestinal tissue sample is assessed using β-Actin ELISA Kit

Secondary outcomes

  1. Histologic Findings

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

dr. Riana Pauline Tamba, SpB(K)BA

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 1, 2019
Registry last updated
Mar 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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