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

Completed

• Conditions: Short Bowel Syndrome; Complications
• Interventions: Other: Complications

• Registration Number: NCT02699320
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2015-06
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2016-02
• Study First Submitted: 2016-02-02
• Study First Submitted QC: 2016-03-03
• Last Update Submitted: 2016-03-03
• Study First Posted: 2016-03-04
• Last Update Posted: 2016-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• Infants with short bowel syndrome

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
healthy controls	Complications	Seven healthy infants who had added complementary were served as controls (n=7).
"Asymptomatic"	Complications	"Asymptomatic" meaning patients showed well tolerance to parenteral nutrient (PN) administration and there were no complications occurred within two months (n=7);
PNALD	Complications	with parenteral nutrient associated liver disease (PNALD), meaning SBS patients showed elevated liver enzymes and bilirubin (n=14).
CLABSI	Complications	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)

Primary Outcome Measures

Name	Time	Method
Microbial structure in SBS infants	up to 4 months	Fecal microbiota were detected by 16S rRNA gene sequencing.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ethics Committee of Xinhua Hospital; 🇨🇳 Shanghai, Shanghai, China