Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2026-01-29 @ 8:33 AM
Study NCT ID:
NCT02699320
Status:
COMPLETED
Last Update Posted:
2016-03-04
First Post:
2016-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intestinal Microbial Dysbiosis in Chinese Infants With Short Bowel Syndrome With Different Complications
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012778', 'term': 'Short Bowel Syndrome'}], 'ancestors': [{'id': 'D008286', 'term': 'Malabsorption Syndromes'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-03', 'studyFirstSubmitDate': '2016-02-02', 'studyFirstSubmitQcDate': '2016-03-03', 'lastUpdatePostDateStruct': {'date': '2016-03-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-03-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Microbial structure in SBS infants', 'timeFrame': 'up to 4 months', 'description': 'Fecal microbiota were detected by 16S rRNA gene sequencing.'}], 'secondaryOutcomes': [{'measure': 'Metabolism products in SBS infants', 'timeFrame': 'up to 4 months', 'description': 'Bile acids and short chain fatty acids were detected by liquid/gas chromatography.'}, {'measure': 'Immune biomarkers in SBS infants', 'timeFrame': 'up to 4 months', 'description': 'Secretary IgA and calprotectin were detected by enzyme-linked immunosorbent assay.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Short bowel syndrome', 'Intestinal microbiota', 'immune'], 'conditions': ['Short Bowel Syndrome', 'Complications']}, 'referencesModule': {'references': [{'pmid': '9352883', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '15137001', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '12761723', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '26770121', 'type': 'RESULT', 'citation': 'Bull MJ, Plummer NT. Part 1: The Human Gut Microbiome in Health and Disease. Integr Med (Encinitas). 2014 Dec;13(6):17-22.'}, {'pmid': '8769294', 'type': 'RESULT', 'citation': "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."}, {'pmid': '9702641', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '24637596', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '26708682', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '23381820', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '20172013', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '25941569', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '26059898', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '25858884', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '25841540', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '20179637', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '1734846', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '23395169', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '24999016', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '23486247', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '8014762', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '20413553', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '3904599', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '11017846', 'type': 'RESULT', 'citation': 'Bhatti MA, Frank MO. Veillonella parvula meningitis: case report and review of Veillonella infections. Clin Infect Dis. 2000 Sep;31(3):839-40. doi: 10.1086/314046.'}, {'pmid': '18927210', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '24392360', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '2680869', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '2807157', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'There are no reports involved the intestinal microbiota from Chinese infants with short bowel syndrome (SBS) under different clinical status. Alterations in the microbiota are closely correlated with the bile acids and short chain fatty acids metabolism as well as the intestinal immunity. A relatively comprehensive profile composed of microbial structure, microbial metabolism products and immune biomarkers in SBS infants may facilitate a better therapy strategy to complications occurred in SBS children.', 'detailedDescription': 'The investigators totally collected 26 fecal samples from 18 infants diagnosed with SBS during parenteral nutrition administration, and these samples were divided into three groups according to complications of enrolled patients at sampling time: asymptomatic group, central catheter-related blood stream infections group and liver injury group. 7 healthy infants with supplementary food were enrolled as control. Fecal microbiota, sIgA and calprotectin, bile acids and short chain fatty acids were also detected by 16S ribosomal ribonucleic acid (rRNA) gene sequencing, enzyme-linked immunosorbent assay and liquid/gas chromatography.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Year', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '18 infants diagnosed with SBS were enrolled from Digestion and Nutrition Division at Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infants with short bowel syndrome'}, 'identificationModule': {'nctId': 'NCT02699320', 'acronym': 'MSBS', 'briefTitle': 'Intestinal Microbial Dysbiosis in Chinese Infants With Short Bowel Syndrome With Different Complications', 'organization': {'class': 'OTHER', 'fullName': 'Xinhua Hospital, Shanghai Jiao Tong University School of Medicine'}, 'officialTitle': 'Multi-center Clinical Research About Standard Diagnosis and Treatment of Neonate Severe Digestive System Malformation', 'orgStudyIdInfo': {'id': 'XH-16-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': '"Asymptomatic"', 'description': '"Asymptomatic" meaning patients showed well tolerance to parenteral nutrient (PN) administration and there were no complications occurred within two months (n=7);', 'interventionNames': ['Other: Complications']}, {'label': 'CLABSI', 'description': '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)', 'interventionNames': ['Other: Complications']}, {'label': 'PNALD', 'description': 'with parenteral nutrient associated liver disease (PNALD), meaning SBS patients showed elevated liver enzymes and bilirubin (n=14).', 'interventionNames': ['Other: Complications']}, {'label': 'healthy controls', 'description': 'Seven healthy infants who had added complementary were served as controls (n=7).', 'interventionNames': ['Other: Complications']}], 'interventions': [{'name': 'Complications', 'type': 'OTHER', 'description': 'Not involved', 'armGroupLabels': ['"Asymptomatic"', 'CLABSI', 'PNALD', 'healthy controls']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200092', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Ethics Committee of Xinhua Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Guangyu Chen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai Municipal Science and Technology Commission'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xinhua Hospital, Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD.', 'investigatorFullName': 'Jiang WU', 'investigatorAffiliation': 'Xinhua Hospital, Shanghai Jiao Tong University School of Medicine'}}}}