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Completed

NCT Number: NCT02699320

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

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.

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Key information

Conditions

Short Bowel Syndrome Complications Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Malabsorption Syndromes Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

Up to 1 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ethics Committee of Xinhua Hospital

Shanghai, Shanghai Municipality, 200092, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Infants with short bowel syndrome

Treatment and study plan

Complications

Other

Not involved

Primary outcomes

  1. Microbial structure in SBS infants

    Time frame: up to 4 months

    Fecal microbiota were detected by 16S rRNA gene sequencing.

Secondary outcomes

  1. Metabolism products in SBS infants

    Time frame: up to 4 months

    Bile acids and short chain fatty acids were detected by liquid/gas chromatography.

  2. Immune biomarkers in SBS infants

    Time frame: up to 4 months

    Secretary IgA and calprotectin were detected by enzyme-linked immunosorbent assay.

Sponsors and collaborators

Lead sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

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

Acronym: MSBS

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 4, 2016
Registry last updated
Mar 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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