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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

Tracking Information
First Submitted Date  ICMJE June 26, 2019
First Posted Date  ICMJE July 1, 2019
Last Update Posted Date March 17, 2020
Actual Study Start Date  ICMJE March 1, 2019
Actual Primary Completion Date September 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 27, 2019)
  • Occludin [ Time Frame: 2 weeks ]
    Measurement of occludin (ng/mg protein) from intestinal tissue sample is assessed using Rabbit Occludin ELISA Kit
  • 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
  • β-actin [ Time Frame: 2 weeks ]
    Measurement of β-actin (ng/mg protein) from intestinal tissue sample is assessed using β-Actin ELISA Kit
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 27, 2019)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prenatal Administration of Spermine Promotes Maturation of Premature Fetal Gut Epithelial Tight Junction: Experimental Study on Fetal Rabbit
Official Title  ICMJE Prenatal Administration of Oral Spermine Promotes Maturation of Premature Fetal Gut Epithelial Tight Junction: Experimental Study on Oryctolagus Cuniculus
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Premature Birth
  • NEC
Intervention  ICMJE Biological: Spermine
Spermine is a polyamine. It is an organic molecule that is involved in cellular metabolism and development.
Study Arms  ICMJE
  • 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.
    Intervention: Biological: Spermine
  • 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.
    Intervention: Biological: Spermine
  • 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.
    Intervention: Biological: Spermine
  • 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 13, 2020)
42
Original Estimated Enrollment  ICMJE
 (submitted: June 27, 2019)
24
Actual Study Completion Date  ICMJE September 30, 2019
Actual Primary Completion Date September 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 28 Days   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Indonesia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04004091
Other Study ID Numbers  ICMJE tight junction, spermine
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party dr. Riana Pauline Tamba, SpB(K)BA, Indonesia University
Study Sponsor  ICMJE dr. Riana Pauline Tamba, SpB(K)BA
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Indonesia University
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP