Microbiota is Related With Increasing Infection Rates After Splenectomy

NCT03420599 — Unknown, 80 participants, First Affiliated Hospital of Harbin Medical University

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Altered Microbiota is Related Increased Infection Rates After Traumatic Splenectomy

RegistryNCT03420599
StatusUnknown
Study typeObservational
Enrollment80 (Estimated)
SponsorFirst Affiliated Hospital of Harbin Medical University (Other)
ConditionsGut Microbiota, Spleen Injury, Infection
Interventionssplenectomy (Procedure)
Datesstart 2017-05-01, primary completion 2019-11-25 (estimated), completion 2019-12-10 (estimated), first posted 2018-02-05, last updated 2019-02-25
Locations1 site in China

Related Papers Related Patents Related Grants Related Experts
All trials for Gut Microbiota All trials for Spleen Injury All trials of splenectomy

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
health controlhealthy controls are all from normal volunteers
splenectomyProcedure: splenectomyTraumatic patients after total splenectomy
  • splenectomy (Procedure): Traumatic patients who performed total splenectomy

+Outcome measures

Primary outcomes

  • Transcriptional changes in gut microbiota [Baseline, 6 months after surgery, 12 months after surgery, 24 months after surgery]: 16S rRNA gene sequencing will be performed with stander procedure
  • Transcriptional changes in plasma LPS levels [Baseline, 6 months after surgery, 12 months after surgery, 24 months after surgery]: Plasma LPS level will be measured by ELISA

Secondary outcomes

  • Fecal SIgA [Baseline, 6 months after surgery, 12 months after surgery, 24 months after surgery]: Fecal SIgA antibody will be measured by ELISA
  • Fecal calprotectin [Baseline, 6 months after surgery, 12 months after surgery, 24 months after surgery]: Fecal SIgA antibody will be measured by ELISA
  • Plasma DAO [Baseline, 6 months after surgery, 12 months after surgery, 24 months after surgery]: Plasma DAO antibody will be measured by ELISA
  • Plasma D-Lac [Baseline, 6 months after surgery, 12 months after surgery, 24 months after surgery]: Plasma D-Lac antibody will be measured by ELISA

+Eligibility

Sex: All, ages: 18 Years to any, accepts healthy volunteers

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

+Locations (1)

FacilityCityCountryStatus
First affiliated hospital of Harbin medical universityHarbin, HeilongjiangChinaRecruiting

+Investigators

  • Wei Yunwei, Study director, First Affiliated Hospital of Harbin Medical University