Clinical trial NCT03420599: Microbiota is Related With Increasing Infection Rates After Splenectomy
Official title: Altered Microbiota is Related Increased Infection Rates After Traumatic Splenectomy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gut Microbiota
Spleen Injury
Infection
Keywords: Gut microbiota
Splenectomy
Infection
Immune
Cytokines
Lead sponsor: First Affiliated Hospital of Harbin Medical University
Sponsor class: OTHER
First posted: 2018-02-05
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Study Population are aged from 18 to 65 years，which divided into 2 groups: Splenectomy, healthy controls

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Transcriptional changes in gut microbiota
timeFrame: Baseline, 6 months after surgery, 12 months after surgery, 24 months after surgery
measure: Transcriptional changes in plasma LPS levels
timeFrame: Baseline, 6 months after surgery, 12 months after surgery, 24 months after surgery
Secondary outcomes:
measure: Fecal SIgA
timeFrame: Baseline, 6 months after surgery, 12 months after surgery, 24 months after surgery
measure: Fecal calprotectin
timeFrame: Baseline, 6 months after surgery, 12 months after surgery, 24 months after surgery
measure: Plasma DAO
timeFrame: Baseline, 6 months after surgery, 12 months after surgery, 24 months after surgery
measure: Plasma D-Lac
timeFrame: Baseline, 6 months after surgery, 12 months after surgery, 24 months after surgery
Other outcomes:
Locations:
city: Harbin
country: China
facility: First affiliated hospital of Harbin medical university
state: Heilongjiang
Study officials:
affiliation: First Affiliated Hospital of Harbin Medical University
name: Wei Yunwei
role: STUDY_DIRECTOR
References: