Microbiota is Related With Increasing Infection Rates After Splenectomy

Infection Clinical Trial

Official title:

Altered Microbiota is Related Increased Infection Rates After Traumatic Splenectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03420599
• Other study ID #: Yunwei Wei 2017-12-20
• Status: Recruiting
• Start date: May 1, 2017
• Est. completion date: December 10, 2019

Study information

• Verified date: December 2018
• Source: First Affiliated Hospital of Harbin Medical University
• Contact: Wei Yunwei
• Phone: +86-0451-85553099
• Email: hydwyw11[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 10, 2019
• Est. primary completion date: November 25, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Gut Microbiota
• Infection
• Spleen Injury

Intervention

Procedure:
• splenectomy
Traumatic patients who performed total splenectomy

Locations

Country	Name	City	State
China	First affiliated hospital of Harbin medical university	Harbin	Heilongjiang

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Harbin Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Fecal SIgA	Fecal SIgA antibody will be measured by ELISA	Baseline, 6 months after surgery, 12 months after surgery, 24 months after surgery
Secondary	Fecal calprotectin	Fecal SIgA antibody will be measured by ELISA	Baseline, 6 months after surgery, 12 months after surgery, 24 months after surgery
Secondary	Plasma DAO	Plasma DAO antibody will be measured by ELISA	Baseline, 6 months after surgery, 12 months after surgery, 24 months after surgery
Secondary	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