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Trial record 1 of 1 for:    23486247 [PUBMED-IDS]
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Intestinal Microbial Dysbiosis in Chinese Infants With Short Bowel Syndrome With Different Complications (MSBS)

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ClinicalTrials.gov Identifier: NCT02699320
Recruitment Status : Completed
First Posted : March 4, 2016
Last Update Posted : March 4, 2016
Sponsor:
Information provided by (Responsible Party):
Jiang WU, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Brief Summary:
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.

Condition or disease Intervention/treatment
Short Bowel Syndrome Complications Other: Complications

Detailed Description:
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.

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Study Type : Observational
Actual Enrollment : 33 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Multi-center Clinical Research About Standard Diagnosis and Treatment of Neonate Severe Digestive System Malformation
Study Start Date : June 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

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Group/Cohort Intervention/treatment
"Asymptomatic"
"Asymptomatic" meaning patients showed well tolerance to parenteral nutrient (PN) administration and there were no complications occurred within two months (n=7);
Other: 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)
Other: Complications
Not involved

PNALD
with parenteral nutrient associated liver disease (PNALD), meaning SBS patients showed elevated liver enzymes and bilirubin (n=14).
Other: Complications
Not involved

healthy controls
Seven healthy infants who had added complementary were served as controls (n=7).
Other: Complications
Not involved




Primary Outcome Measures :
  1. Microbial structure in SBS infants [ Time Frame: up to 4 months ]
    Fecal microbiota were detected by 16S rRNA gene sequencing.


Secondary Outcome Measures :
  1. Metabolism products in SBS infants [ Time Frame: up to 4 months ]
    Bile acids and short chain fatty acids were detected by liquid/gas chromatography.

  2. Immune biomarkers in SBS infants [ Time Frame: up to 4 months ]
    Secretary IgA and calprotectin were detected by enzyme-linked immunosorbent assay.



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Ages Eligible for Study:   up to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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.
Criteria

Inclusion Criteria:

  • Infants with short bowel syndrome

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02699320


Locations
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China, Shanghai
Ethics Committee of Xinhua Hospital
Shanghai, Shanghai, China, 200092
Sponsors and Collaborators
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Investigators
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Principal Investigator: Guangyu Chen, PhD Science and Technology Commission of Shanghai Municipality

Publications of Results:

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Responsible Party: Jiang WU, MD., Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT02699320     History of Changes
Other Study ID Numbers: XH-16-001
First Posted: March 4, 2016    Key Record Dates
Last Update Posted: March 4, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jiang WU, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine:
Short bowel syndrome
Intestinal microbiota
immune

Additional relevant MeSH terms:
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Syndrome
Short Bowel Syndrome
Disease
Pathologic Processes
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Postoperative Complications