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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04004091
Other study ID # tight junction, spermine
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
Start date March 1, 2019
Est. completion date September 30, 2019

Study information

Verified date March 2020
Source Indonesia University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date September 30, 2019
Est. primary completion date September 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 28 Days
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Indonesia Dr. Cipto Mangunkusumo National Hospital Jakarta Pusat Jakarta

Sponsors (1)

Lead Sponsor Collaborator
dr. Riana Pauline Tamba, SpB(K)BA

Country where clinical trial is conducted

Indonesia, 

References & Publications (7)

Gréco S, Niepceron E, Hugueny I, George P, Louisot P, Biol MC. Dietary spermidine and spermine participate in the maturation of galactosyltransferase activity and glycoprotein galactosylation in rat small intestine. J Nutr. 2001 Jul;131(7):1890-7. — View Citation

Harada E, Hashimoto Y, Syuto B. Orally administered spermine induces precocious intestinal maturation of macromolecular transport and disaccharidase development in suckling rats. Comp Biochem Physiol A Physiol. 1994 Nov;109(3):667-73. — View Citation

Peulen O, Dandrifosse G. Spermine-induced maturation in wistar rat intestine: a cytokine-dependent mechanism. J Pediatr Gastroenterol Nutr. 2004 May;38(5):524-32. — View Citation

Peulen O, Gharbi M, Powroznik B, Dandrifosse G. Differential effect of dietary spermine on alkaline phosphatase activity in jejunum and ileum of unweaned rats. Biochimie. 2004 Jul;86(7):487-93. — View Citation

Peulen O, Pirlet C, Klimek M, Goffinet G, Dandrifosse G. Comparison between the natural postnatal maturation and the spermine-induced maturation of the rat intestine. Arch Physiol Biochem. 1998 Feb;106(1):46-55. — View Citation

van Wettere WH, Willson NL, Pain SJ, Forder RE. Effect of oral polyamine supplementation pre-weaning on piglet growth and intestinal characteristics. Animal. 2016 Oct;10(10):1655-9. doi: 10.1017/S1751731116000446. Epub 2016 Mar 21. — View Citation

Wéry I, Deloyer P, Dandrifosse G. Effects of a single dose of orally-administered spermine on the intestinal development of unweaned rats. Arch Physiol Biochem. 1996;104(2):163-72. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Occludin Measurement of occludin (ng/mg protein) from intestinal tissue sample is assessed using Rabbit Occludin ELISA Kit 2 weeks
Primary ß-catenin Measurement of ß-catenin (pg/mg protein) from intestinal tissue sample is assessed using Rabbit ß-Catenin ELISA Kit 2 weeks
Primary ß-actin Measurement of ß-actin (ng/mg protein) from intestinal tissue sample is assessed using ß-Actin ELISA Kit 2 weeks
Secondary Histologic Findings 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
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