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

Short Bowel Syndrome Clinical Trial

— MSBS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02699320
• Other study ID #: XH-16-001
• Status: Completed
• Phase: N/A
• First received: February 2, 2016
• Last updated: March 3, 2016
• Start date: June 2015
• Est. completion date: January 2016

Study information

• Verified date: February 2016
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Science and Technology Commission of Shanghai Municipality
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 1 Year

Eligibility

Inclusion Criteria:

• Infants with short bowel syndrome

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Complications
• Short Bowel Syndrome

Intervention

Other:
• Complications
Not involved

Locations

Country	Name	City	State
China	Ethics Committee of Xinhua Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

References & Publications (27)

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* Note: There are 27 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microbial structure in SBS infants	Fecal microbiota were detected by 16S rRNA gene sequencing.	up to 4 months	Yes
Secondary	Metabolism products in SBS infants	Bile acids and short chain fatty acids were detected by liquid/gas chromatography.	up to 4 months	Yes
Secondary	Immune biomarkers in SBS infants	Secretary IgA and calprotectin were detected by enzyme-linked immunosorbent assay.	up to 4 months	Yes