Microbiota is Related With Increasing Infection Rates After Splenectomy

Altered Microbiota is Related Increased Infection Rates After Traumatic Splenectomy

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.

Study Overview

• Status: Unknown
• Conditions: Infection; Gut Microbiota; Spleen Injury
• Intervention / Treatment: Procedure: splenectomy

Detailed Description

The spleen is crucial in regulating immune homoeostasis through its ability to link innate and adaptive immunity and to protect against infections. Asplenia refers to the absence of the spleen, a disorder that is rarely congenital and is more frequently as a result of surgery. Splenic hypofunction, as a result of asplenia can lead a series of changes in body systems. Recent study has show an increasingly infection rate after splenectomy including abdominal infection, pulmonary infection and cranial cavity infection.

The gastrointestinal tract plays host to a diverse and metabolically complex community of microorganisms. Recent literature suggests that organisms in the gastrointestinal tract, referred to collectively as gut microbiota, play an indispensable role in the maintenance of host's homeostasis. Study has proved a potential correlation between microbiota and immune system. Lymphocyte, in either peripheral circulation or mesenteric lymph node, altered can lead to an composition change in microbiota.

Investigators suppose that this phenomenon can be associated with the alteration of the resident commensal microenvironment after splenectomy compared to commensal communities. 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.

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

• Study Contact: Name: Wei Yunwei; Phone Number: +86-0451-85553099; Email: hydwyw11@hotmail.com

Study Locations

• China
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150001
      • Recruiting
      • First Affiliated Hospital of Harbin Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
health control; healthy controls are all from normal volunteers
splenectomy; Traumatic patients after total splenectomy	Procedure: splenectomy; Traumatic patients who performed total splenectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fecal SIgA	Fecal SIgA antibody will be measured by ELISA	Baseline, 6 months after surgery, 12 months after surgery, 24 months after surgery
Fecal calprotectin	Fecal SIgA antibody will be measured by ELISA	Baseline, 6 months after surgery, 12 months after surgery, 24 months after surgery
Plasma DAO	Plasma DAO antibody will be measured by ELISA	Baseline, 6 months after surgery, 12 months after surgery, 24 months after surgery
Plasma D-Lac	Plasma D-Lac antibody will be measured by ELISA	Baseline, 6 months after surgery, 12 months after surgery, 24 months after surgery

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Harbin Medical University
• Investigators: Study Director: Wei Yunwei, First Affiliated Hospital of Harbin Medical University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Anticipated): November 25, 2019
• Study Completion (Anticipated): December 10, 2019

Study Registration Dates

• First Submitted: December 24, 2017
• First Submitted That Met QC Criteria: January 29, 2018
• First Posted (Actual): February 5, 2018

Study Record Updates

• Last Update Posted (Actual): February 25, 2019
• Last Update Submitted That Met QC Criteria: February 22, 2019
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Infection; Immune; Cytokines; Gut microbiota; Splenectomy
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: Yunwei Wei 2017-12-20

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No