Intestinal Microbial Dysbiosis in Chinese Infants With Short Bowel Syndrome With Different Complications
NCT ID: NCT02699320
Last Updated: 2016-03-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
33 participants
OBSERVATIONAL
2015-06-30
2016-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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"Asymptomatic"
"Asymptomatic" meaning patients showed well tolerance to parenteral nutrient (PN) administration and there were no complications occurred within two months (n=7);
Complications
Not involved
CLABSI
with central catheter-related blood stream infections (CLABSI) meaning patients had fever, increased neutrophils, documented positive catheter blood culture but exclude other source of infection (n=5)
Complications
Not involved
PNALD
with parenteral nutrient associated liver disease (PNALD), meaning SBS patients showed elevated liver enzymes and bilirubin (n=14).
Complications
Not involved
healthy controls
Seven healthy infants who had added complementary were served as controls (n=7).
Complications
Not involved
Interventions
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Complications
Not involved
Eligibility Criteria
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Inclusion Criteria
1 Year
ALL
No
Sponsors
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Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
OTHER
Responsible Party
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Jiang WU
MD.
Principal Investigators
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Guangyu Chen, PhD
Role: PRINCIPAL_INVESTIGATOR
Shanghai Municipal Science and Technology Commission
Locations
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Ethics Committee of Xinhua Hospital
Shanghai, Shanghai Municipality, China
Countries
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References
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Vanderhoof JA, Langnas AN. Short-bowel syndrome in children and adults. Gastroenterology. 1997 Nov;113(5):1767-78. doi: 10.1053/gast.1997.v113.pm9352883.
Wales PW, de Silva N, Kim J, Lecce L, To T, Moore A. Neonatal short bowel syndrome: population-based estimates of incidence and mortality rates. J Pediatr Surg. 2004 May;39(5):690-5. doi: 10.1016/j.jpedsurg.2004.01.036.
Howard L, Ashley C. Management of complications in patients receiving home parenteral nutrition. Gastroenterology. 2003 May;124(6):1651-61. doi: 10.1016/s0016-5085(03)00326-3.
Bull MJ, Plummer NT. Part 1: The Human Gut Microbiome in Health and Disease. Integr Med (Encinitas). 2014 Dec;13(6):17-22.
Caldarini MI, Pons S, D'Agostino D, DePaula JA, Greco G, Negri G, Ascione A, Bustos D. Abnormal fecal flora in a patient with short bowel syndrome. An in vitro study on effect of pH on D-lactic acid production. Dig Dis Sci. 1996 Aug;41(8):1649-52. doi: 10.1007/BF02087915.
Sondheimer JM, Asturias E, Cadnapaphornchai M. Infection and cholestasis in neonates with intestinal resection and long-term parenteral nutrition. J Pediatr Gastroenterol Nutr. 1998 Aug;27(2):131-7. doi: 10.1097/00005176-199808000-00001.
Winter SE, Baumler AJ. Dysbiosis in the inflamed intestine: chance favors the prepared microbe. Gut Microbes. 2014 Jan-Feb;5(1):71-3. doi: 10.4161/gmic.27129. Epub 2014 Jan 29.
Halmos T, Suba I. [Physiological patterns of intestinal microbiota. The role of dysbacteriosis in obesity, insulin resistance, diabetes and metabolic syndrome]. Orv Hetil. 2016 Jan 3;157(1):13-22. doi: 10.1556/650.2015.30296. Hungarian.
Furtado Ede C, Marchini JS, Fonseca CK, Coelho PS, Menegueti MG, Auxiliadora-Martins M, Basile-Filho A, Suen VM. Cyclic parenteral nutrition does not change the intestinal microbiota in patients with short bowel syndrome. Acta Cir Bras. 2013;28 Suppl 1:26-32. doi: 10.1590/s0102-86502013001300006.
Joly F, Mayeur C, Bruneau A, Noordine ML, Meylheuc T, Langella P, Messing B, Duee PH, Cherbuy C, Thomas M. Drastic changes in fecal and mucosa-associated microbiota in adult patients with short bowel syndrome. Biochimie. 2010 Jul;92(7):753-61. doi: 10.1016/j.biochi.2010.02.015. Epub 2010 Feb 19.
Engstrand Lilja H, Wefer H, Nystrom N, Finkel Y, Engstrand L. Intestinal dysbiosis in children with short bowel syndrome is associated with impaired outcome. Microbiome. 2015 May 4;3:18. doi: 10.1186/s40168-015-0084-7. eCollection 2015.
Davidovics ZH, Carter BA, Luna RA, Hollister EB, Shulman RJ, Versalovic J. The Fecal Microbiome in Pediatric Patients With Short Bowel Syndrome. JPEN J Parenter Enteral Nutr. 2016 Nov;40(8):1106-1113. doi: 10.1177/0148607115591216. Epub 2015 Jun 9.
Bharadwaj S, Gohel T, Deen OJ, DeChicco R, Shatnawei A. Fish oil-based lipid emulsion: current updates on a promising novel therapy for the management of parenteral nutrition-associated liver disease. Gastroenterol Rep (Oxf). 2015 May;3(2):110-4. doi: 10.1093/gastro/gov011. Epub 2015 Apr 8.
Raphael BP, Mitchell PD, Finkton D, Jiang H, Jaksic T, Duggan C. Necrotizing Enterocolitis and Central Line Associated Blood Stream Infection Are Predictors of Growth Outcomes in Infants with Short Bowel Syndrome. J Pediatr. 2015 Jul;167(1):35-40.e1. doi: 10.1016/j.jpeds.2015.02.053. Epub 2015 Apr 1.
Greenberg RG, Moran C, Ulshen M, Smith PB, Benjamin DK Jr, Cohen-Wolkowiez M. Outcomes of catheter-associated infections in pediatric patients with short bowel syndrome. J Pediatr Gastroenterol Nutr. 2010 Apr;50(4):460-2. doi: 10.1097/MPG.0b013e3181b99d07.
Kurkchubasche AG, Smith SD, Rowe MI. Catheter sepsis in short-bowel syndrome. Arch Surg. 1992 Jan;127(1):21-4; discussion 24-5. doi: 10.1001/archsurg.1992.01420010027004.
Sayin SI, Wahlstrom A, Felin J, Jantti S, Marschall HU, Bamberg K, Angelin B, Hyotylainen T, Oresic M, Backhed F. Gut microbiota regulates bile acid metabolism by reducing the levels of tauro-beta-muricholic acid, a naturally occurring FXR antagonist. Cell Metab. 2013 Feb 5;17(2):225-35. doi: 10.1016/j.cmet.2013.01.003.
Pereira-Fantini PM, Lapthorne S, Joyce SA, Dellios NL, Wilson G, Fouhy F, Thomas SL, Scurr M, Hill C, Gahan CG, Cotter PD, Fuller PJ, Hardikar W, Bines JE. Altered FXR signalling is associated with bile acid dysmetabolism in short bowel syndrome-associated liver disease. J Hepatol. 2014 Nov;61(5):1115-25. doi: 10.1016/j.jhep.2014.06.025. Epub 2014 Jul 3.
Amato KR, Yeoman CJ, Kent A, Righini N, Carbonero F, Estrada A, Gaskins HR, Stumpf RM, Yildirim S, Torralba M, Gillis M, Wilson BA, Nelson KE, White BA, Leigh SR. Habitat degradation impacts black howler monkey (Alouatta pigra) gastrointestinal microbiomes. ISME J. 2013 Jul;7(7):1344-53. doi: 10.1038/ismej.2013.16. Epub 2013 Mar 14.
Treem WR, Ahsan N, Shoup M, Hyams JS. Fecal short-chain fatty acids in children with inflammatory bowel disease. J Pediatr Gastroenterol Nutr. 1994 Feb;18(2):159-64. doi: 10.1097/00005176-199402000-00007.
Michon AL, Aujoulat F, Roudiere L, Soulier O, Zorgniotti I, Jumas-Bilak E, Marchandin H. Intragenomic and intraspecific heterogeneity in rrs may surpass interspecific variability in a natural population of Veillonella. Microbiology (Reading). 2010 Jul;156(Pt 7):2080-2091. doi: 10.1099/mic.0.038224-0. Epub 2010 Apr 22.
Delwiche EA, Pestka JJ, Tortorello ML. The veillonellae: gram-negative cocci with a unique physiology. Annu Rev Microbiol. 1985;39:175-93. doi: 10.1146/annurev.mi.39.100185.001135. No abstract available.
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Chichlowski M, Hale LP. Bacterial-mucosal interactions in inflammatory bowel disease: an alliance gone bad. Am J Physiol Gastrointest Liver Physiol. 2008 Dec;295(6):G1139-49. doi: 10.1152/ajpgi.90516.2008. Epub 2008 Oct 16.
Demehri FR, Barrett M, Ralls MW, Miyasaka EA, Feng Y, Teitelbaum DH. Intestinal epithelial cell apoptosis and loss of barrier function in the setting of altered microbiota with enteral nutrient deprivation. Front Cell Infect Microbiol. 2013 Dec 23;3:105. doi: 10.3389/fcimb.2013.00105. eCollection 2013.
Nolan JP. Intestinal endotoxins as mediators of hepatic injury--an idea whose time has come again. Hepatology. 1989 Nov;10(5):887-91. doi: 10.1002/hep.1840100523. No abstract available.
Guarner F, Wallace JL, MacNaughton WK, Ibbotson GC, Arroyo V, Rodes J. Endotoxin-induced ascites formation in the rat: partial mediation by platelet-activating factor. Hepatology. 1989 Nov;10(5):788-94. doi: 10.1002/hep.1840100507.
Other Identifiers
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XH-16-001
Identifier Type: -
Identifier Source: org_study_id
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