Microbial Diversity of Small Bowel Stoma Effluent and Colonic Faeces

February 10, 2019 updated by: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Intestinal Microbial Diversity of Small Bowel Stoma Effluent and Colonic Feces of Children With Short Bowel Syndrome

Several studies suggested that dysbacteriosis usually happened in patients with intestinal failure (IF). However, differences of microbiota diversity in small intestine stoma effluents and colonic faeces were rarely studies. Thus this study is aimed to investigate the microbiota compositions and differences of output of small intestine stoma and colon in pediatric IF patients. Fecal samples from IF patients. Each patient received fistula closure in our centre and fecal samples from both small intestinal stoma and colon were collected. Fecal microbial compositions were determined by high-throughput sequencing.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Shanghai Xinhua Hospital, affiliated to Shanghai Jiao Tong University, School of Medicine
        • Contact:
          • Wei Cai, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 3 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hospitalized patients

Description

Inclusion Criteria:

  • Patients with intestinal failure. Patients showed good tolerance to parenteral and enteral nutrition administration. Proportion of enteral nutrition is more than 80%.

Stool output maintained at less than 50mL/kg/day. No complications occurred for at least 1 week.

Exclusion Criteria:

  • Patients depend mainly on parenteral nutrition. Symptoms like fever, abdominal distention and diarrhea. Complications like parenteral nutrition-associated liver disease, pneumonia and catheter related infection.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intestinal stoma output
No interventions.
Colonic feaces
No interventions.
Healthy Control
No interventions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microbiota diversity and composition clarified by 16s rRNA sequencing
Time Frame: 1)Samples collection: one day before patients are discharged from hospital; 2)DNA extraction: within one week after samples collection; 3)Sequencing and data analyzing: within one month after DNA extract
DNA of gut microbiota will be extracted. Then purified DNA amplicons are pooled in equimolar and paired-end sequenced (2 × 250) on an Illumina MiSeq platform. Raw Fastq files will be de-multiplexed, quality-filtered using QIIME (version 1.17). Operational taxonomic units (OTUs) will be next clustered with 97% similarity cutoff using UPARSE version 7.1 (http://drive5.com/ uparse/) and chimeric sequences will be identified and removed using UCHIME (http://drive5.com/index.htm). The phylogenetic affiliation of each 16S rRNA gene sequence is analyzed by RDP Classifier (http:// rdp.cme.msu.edu/) against the silva (SSU117/119)16S rRNA. Sobs index and Chao index will be used to evaluate the microbiota diversity. Microbiota composition will be identified on different levels including phylum, family and genus.
1)Samples collection: one day before patients are discharged from hospital; 2)DNA extraction: within one week after samples collection; 3)Sequencing and data analyzing: within one month after DNA extract

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Collaborators

National Natural Science Foundation of China
Shanghai Municipal Science and Technology Commission

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Anticipated)

December 15, 2019

Study Completion (Anticipated)

June 1, 2020

Study Registration Dates

First Submitted

June 15, 2018

First Submitted That Met QC Criteria

July 5, 2018

First Posted (Actual)

July 18, 2018

Study Record Updates

Last Update Posted (Actual)

February 15, 2019

Last Update Submitted That Met QC Criteria

February 10, 2019

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ShanghaiXinhua

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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