Microbiota is Related With Increasing Infection Rates After Splenectomy

NCT03420599 | Unknown

• 1 other identifier: Yunwei Wei 2017-12-20
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Studies has shown an increasingly infection rate after splenectomy, and there is a potential correlation between microbiota and immune system. investigators suppose that increasingly infection can be associated with the alteration composition of the gut microbiota after splenectomy. It's investigators' aim to discover if any difference of gut microbiota is exist in patients who suffer from traumatic splenectomy compared with normal people, ultimately aim toreduce and mitigation infection rate through controlling gut microbiota.

Conditions

Gut Microbiota; Spleen Injury; Infection

Keywords

Gut microbiota; Splenectomy; Infection; Immune; Cytokines

Outcome Measures

Primary Outcomes (2)

• Transcriptional changes in gut microbiota

  16S rRNA gene sequencing will be performed with stander procedure

  Baseline, 6 months after surgery, 12 months after surgery, 24 months after surgery

• Transcriptional changes in plasma LPS levels

  Plasma LPS level will be measured by ELISA

  Baseline, 6 months after surgery, 12 months after surgery, 24 months after surgery

Secondary Outcomes (4)

• Fecal SIgA

  Baseline, 6 months after surgery, 12 months after surgery, 24 months after surgery

• Fecal calprotectin

  Baseline, 6 months after surgery, 12 months after surgery, 24 months after surgery

• Plasma DAO

  Baseline, 6 months after surgery, 12 months after surgery, 24 months after surgery

• Plasma D-Lac

  Baseline, 6 months after surgery, 12 months after surgery, 24 months after surgery

Study Arms (2)

health control

healthy controls are all from normal volunteers

splenectomy

Traumatic patients after total splenectomy

Procedure: splenectomy

Interventions

splenectomy PROCEDURE

Traumatic patients who performed total splenectomy

splenectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Study Population are aged from 18 to 65 years，which divided into 2 groups: Splenectomy, healthy controls

You may qualify if:

• All the patients underwent an total splenectomy in the First Affiliated Hospital of Harbin Medical University from January 1st, 2015 to May 1st, 2017. Each participant provided a fresh stool sample in hospital when following-up.

You may not qualify if:

• Use antibiotics and probiotics 3 mouth before samples collection.
• Other severe abdomen injury
• Underwent abdomen organ resection surgery
• Other digestive system disease

Sponsors & Collaborators

• First Affiliated Hospital of Harbin Medical University: lead

Study Sites (1)

First affiliated hospital of Harbin medical university

Harbin, Heilongjiang, 150001, China

RECRUITING

MeSH Terms

Conditions

Infections

Interventions

Splenectomy

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Wei Yunwei

  First Affiliated Hospital of Harbin Medical University

  STUDY DIRECTOR

Central Study Contacts

Wei Yunwei

CONTACT

+86-0451-85553099; hydwyw11@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2017
• First Posted: February 5, 2018
• Study Start: May 1, 2017
• Primary Completion: November 25, 2019
• Study Completion: December 10, 2019
• Last Updated: February 25, 2019

Record last verified: 2018-12

Locations

CN (1)