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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Short Bowel Syndrome, Complications

Intervention / Treatment
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* Other: Complications


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infants with short bowel syndrome

Ages Eligible for Study
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Maximum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Asymptomatic<br>Asymptomatic meaning patients showed well tolerance to parenteral nutrient (PN) administration and there were no complications occurred within two months (n=7); | Other: Complications<br>* Not involved<br>|
| CLABSI<br>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<br>* Not involved<br>|
| PNALD<br>with parenteral nutrient associated liver disease (PNALD), meaning SBS patients showed elevated liver enzymes and bilirubin (n=14). | Other: Complications<br>* Not involved<br>|
| healthy controls<br>Seven healthy infants who had added complementary were served as controls (n=7). | Other: Complications<br>* Not involved<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Short bowel syndrome, Intestinal microbiota, immune