Microbial Diversity of Small Bowel Stoma Effluent and Colonic Faeces

NCT ID: NCT03590418

Last Updated: 2019-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-01

Study Completion Date

2020-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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Intestinal Failure

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Intestinal stoma output

No interventions.

No interventions assigned to this group

Colonic feaces

No interventions.

No interventions assigned to this group

Healthy Control

No interventions.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

1 Month

Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shanghai Municipal Science and Technology Commission

OTHER_GOV

Sponsor Role collaborator

National Natural Science Foundation of China

OTHER_GOV

Sponsor Role collaborator

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Shanghai Xinhua Hospital, affiliated to Shanghai Jiao Tong University, School of Medicine

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wei Cai, MD, PhD

Role: CONTACT

Facility Contacts

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Wei Cai, MD, PhD

Role: primary

References

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Arrieta MC, Stiemsma LT, Amenyogbe N, Brown EM, Finlay B. The intestinal microbiome in early life: health and disease. Front Immunol. 2014 Sep 5;5:427. doi: 10.3389/fimmu.2014.00427. eCollection 2014.

Reference Type BACKGROUND
PMID: 25250028 (View on PubMed)

Booijink CC, El-Aidy S, Rajilic-Stojanovic M, Heilig HG, Troost FJ, Smidt H, Kleerebezem M, De Vos WM, Zoetendal EG. High temporal and inter-individual variation detected in the human ileal microbiota. Environ Microbiol. 2010 Dec;12(12):3213-27. doi: 10.1111/j.1462-2920.2010.02294.x.

Reference Type BACKGROUND
PMID: 20626454 (View on PubMed)

Barrett E, Guinane CM, Ryan CA, Dempsey EM, Murphy BP, O'Toole PW, Fitzgerald GF, Cotter PD, Ross RP, Stanton C. Microbiota diversity and stability of the preterm neonatal ileum and colon of two infants. Microbiologyopen. 2013 Apr;2(2):215-25. doi: 10.1002/mbo3.64. Epub 2013 Jan 24.

Reference Type BACKGROUND
PMID: 23349073 (View on PubMed)

Huang Y, Guo F, Li Y, Wang J, Li J. Fecal microbiota signatures of adult patients with different types of short bowel syndrome. J Gastroenterol Hepatol. 2017 Dec;32(12):1949-1957. doi: 10.1111/jgh.13806.

Reference Type BACKGROUND
PMID: 28425133 (View on PubMed)

Other Identifiers

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ShanghaiXinhua

Identifier Type: -

Identifier Source: org_study_id

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