Intestinal Microbial Dysbiosis in Chinese Infants With Short Bowel Syndrome With Different Complications (MSBS)

March 3, 2016 updated by: Jiang WU, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Multi-center Clinical Research About Standard Diagnosis and Treatment of Neonate Severe Digestive System Malformation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

33

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200092
        • Ethics Committee of Xinhua Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

  • Infants with short bowel syndrome

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microbial structure in SBS infants
Time Frame: up to 4 months
Fecal microbiota were detected by 16S rRNA gene sequencing.
up to 4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metabolism products in SBS infants
Time Frame: up to 4 months
Bile acids and short chain fatty acids were detected by liquid/gas chromatography.
up to 4 months
Immune biomarkers in SBS infants
Time Frame: up to 4 months
Secretary IgA and calprotectin were detected by enzyme-linked immunosorbent assay.
up to 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Investigators

  • Principal Investigator: Guangyu Chen, PhD, Science and Technology Commission of Shanghai Municipality

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

February 2, 2016

First Submitted That Met QC Criteria

March 3, 2016

First Posted (Estimate)

March 4, 2016

Study Record Updates

Last Update Posted (Estimate)

March 4, 2016

Last Update Submitted That Met QC Criteria

March 3, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XH-16-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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