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

March 13, 2020 updated by: dr. Riana Pauline Tamba, SpB(K)BA

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • Jakarta
      • Jakarta Pusat, Jakarta, Indonesia, 10340
        • Dr. Cipto Mangunkusumo National Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 weeks to 4 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 24-Day Spermine Group
Subjects are given prenatal spermine (20 mg per body weight) during 24 days of pregnancy. On day 24 pregnancy is terminated and intestinal tissue sample is taken to be examined.
Biological: Spermine
Spermine is a polyamine. It is an organic molecule that is involved in cellular metabolism and development.
Experimental: 26-Day Spermine Group
Subjects are given prenatal spermine (20 mg per body weight) during 26 days of pregnancy. On day 26 pregnancy is terminated and intestinal tissue sample is taken to be examined.
Biological: Spermine
Spermine is a polyamine. It is an organic molecule that is involved in cellular metabolism and development.
Experimental: 28-Day Spermine Group
Subjects are given prenatal spermine (20 mg per body weight) during 28 days of pregnancy. On day 28 pregnancy is terminated and intestinal tissue sample is taken to be examined.
Biological: Spermine
Spermine is a polyamine. It is an organic molecule that is involved in cellular metabolism and development.
No Intervention: 24-Day Non Spermine Group
Subjects are not given any intervention. On day 24 pregnancy is terminated and intestinal tissue sample is taken to be examined.
No Intervention: 26-Day Non Spermine Group
Subjects are not given any intervention. On day 26 pregnancy is terminated and intestinal tissue sample is taken to be examined.
No Intervention: 28-Day Non Spermine Group
Subjects are not given any intervention. On day 28 pregnancy is terminated and intestinal tissue sample is taken to be examined.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

dr. Riana Pauline Tamba, SpB(K)BA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2019

Primary Completion (Actual)

September 30, 2019

Study Completion (Actual)

September 30, 2019

Study Registration Dates

First Submitted

June 26, 2019

First Submitted That Met QC Criteria

June 27, 2019

First Posted (Actual)

July 1, 2019

Study Record Updates

Last Update Posted (Actual)

March 17, 2020

Last Update Submitted That Met QC Criteria

March 13, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • tight junction, spermine

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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