Clinical trial NCT02699320: Intestinal Microbial Dysbiosis in Chinese Infants With Short Bowel Syndrome With Different Complications
Official title: Multi-center Clinical Research About Standard Diagnosis and Treatment of Neonate Severe Digestive System Malformation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Short Bowel Syndrome
Complications
Keywords: Short bowel syndrome
Intestinal microbiota
immune
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2016-03-04
Enrollment: 33
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: Inclusion Criteria:

* Infants with short bowel syndrome

Primary outcomes:
measure: Microbial structure in SBS infants
timeFrame: up to 4 months
Secondary outcomes:
measure: Metabolism products in SBS infants
timeFrame: up to 4 months
measure: Immune biomarkers in SBS infants
timeFrame: up to 4 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ethics Committee of Xinhua Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Municipal Science and Technology Commission
name: Guangyu Chen, PhD
role: PRINCIPAL_INVESTIGATOR
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