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Microbial Diversity of Small Bowel Stoma Effluent and Colonic Faeces

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03590418
Recruitment Status : Unknown
Verified November 2017 by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine.
Recruitment status was:  Recruiting
First Posted : July 18, 2018
Last Update Posted : February 15, 2019
Sponsor:
Collaborators:
Shanghai Municipal Science and Technology Commission
National Natural Science Foundation of China
Information provided by (Responsible Party):
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Study Description
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Brief Summary:
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.

Condition or disease
Intestinal Failure

Study Design
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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Intestinal Microbial Diversity of Small Bowel Stoma Effluent and Colonic Feces of Children With Short Bowel Syndrome
Actual Study Start Date : November 1, 2016
Estimated Primary Completion Date : December 15, 2019
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   1 Month to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Hospitalized patients
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03590418


Contacts
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Contact: Wei Cai, MD, PhD caiw204@sjtu.edu.cn

Locations
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China
Shanghai Xinhua Hospital, affiliated to Shanghai Jiao Tong University, School of Medicine Recruiting
Shanghai, China
Contact: Wei Cai, MD, PhD         
Sponsors and Collaborators
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai Municipal Science and Technology Commission
National Natural Science Foundation of China
More Information
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Publications:

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Responsible Party: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT03590418    
Other Study ID Numbers: ShanghaiXinhua
First Posted: July 18, 2018    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: November 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine:
Intestinal failure
Microbiota