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

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ClinicalTrials.gov Identifier: NCT04004091
Recruitment Status : Completed
First Posted : July 1, 2019
Last Update Posted : March 17, 2020
Sponsor:
Information provided by (Responsible Party):
dr. Riana Pauline Tamba, SpB(K)BA, Indonesia University

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.

Condition or disease Intervention/treatment Phase
Premature Birth NEC Biological: Spermine Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prenatal Administration of Oral Spermine Promotes Maturation of Premature Fetal Gut Epithelial Tight Junction: Experimental Study on Oryctolagus Cuniculus
Actual Study Start Date : March 1, 2019
Actual Primary Completion Date : September 30, 2019
Actual Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04004091


Locations
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Indonesia
Dr. Cipto Mangunkusumo National Hospital
Jakarta Pusat, Jakarta, Indonesia, 10340
Sponsors and Collaborators
dr. Riana Pauline Tamba, SpB(K)BA
Publications:
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Responsible Party: dr. Riana Pauline Tamba, SpB(K)BA, Consultant Pediatric Surgeon, Indonesia University
ClinicalTrials.gov Identifier: NCT04004091    
Other Study ID Numbers: tight junction, spermine
First Posted: July 1, 2019    Key Record Dates
Last Update Posted: March 17, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by dr. Riana Pauline Tamba, SpB(K)BA, Indonesia University:
Premature Birth
Spermine
Necrotizing Enterocolitis
Tight Junction
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications