Premature Birth Clinical Trial
Official title:
Prenatal Administration of Oral Spermine Promotes Maturation of Premature Fetal Gut Epithelial Tight Junction: Experimental Study on Oryctolagus Cuniculus
Verified date | March 2020 |
Source | Indonesia University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Indonesia | Dr. Cipto Mangunkusumo National Hospital | Jakarta Pusat | Jakarta |
Lead Sponsor | Collaborator |
---|---|
dr. Riana Pauline Tamba, SpB(K)BA |
Indonesia,
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
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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