Gut MicrobiotaNCT03420599
Microbiota is Related With Increasing Infection Rates After Splenectomy
An observational study of Gut Microbiota and Spleen Injury, run by First Affiliated Hospital of Harbin Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gut Microbiota, Spleen Injury, Infection
- What is being tested?
- splenectomy
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2017to 10 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study Population are aged from 18 to 65 years，which divided into 2 groups: Splenectomy, healthy controls
Who may be able to join
- 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.
Who cannot join
- Use antibiotics and probiotics 3 mouth before samples collection.
- Other severe abdomen injury
- Underwent abdomen organ resection surgery
- Other digestive system disease
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First affiliated hospital of Harbin medical university
Harbin, Heilongjiang, 150001
Yunwei Wei, +86-0451-85553099, hydwyw11@hotmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Gut Microbiota, Spleen Injury, Infection
- Being tested
- splenectomy
- Keywords
- Gut microbiota, Splenectomy, Infection, Immune, Cytokines
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
splenectomyProcedure or surgery
Traumatic patients who performed total splenectomy
| Study group | Role | What they receive |
|---|---|---|
| health control | healthy controls are all from normal volunteers | |
| splenectomy | Traumatic patients after total splenectomy Receives: Procedure: splenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transcriptional changes in gut microbiota
16S rRNA gene sequencing will be performed with stander procedure
Measured: 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
Measured: Baseline, 6 months after surgery, 12 months after surgery, 24 months after surgery
Secondary outcomes (4)
Fecal SIgA
Fecal SIgA antibody will be measured by ELISA
Measured: Baseline, 6 months after surgery, 12 months after surgery, 24 months after surgery
Fecal calprotectin
Fecal SIgA antibody will be measured by ELISA
Measured: Baseline, 6 months after surgery, 12 months after surgery, 24 months after surgery
Plasma DAO
Plasma DAO antibody will be measured by ELISA
Measured: 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
Measured: Baseline, 6 months after surgery, 12 months after surgery, 24 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start1 May 2017
- Primary completion25 Nov 2019 (estimated)
- Study completion10 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gut MicrobiotaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Harbin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei Yunwei, Study director, First Affiliated Hospital of Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03420599
- Sponsor's protocol ID
- Yunwei Wei 2017-12-20
- Status last verified
- Dec 2018
- First submitted
- 24 Dec 2017
- Last updated
- 25 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Altered Microbiota is Related Increased Infection Rates After Traumatic Splenectomy
- ClinicalTrials.gov ID
- NCT03420599
- Acronym / sponsor ID
- Yunwei Wei 2017-12-20
- Conditions
- Gut Microbiota, Spleen Injury, Infection
- Keywords
- Gut microbiota, Splenectomy, Infection, Immune, Cytokines
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Harbin Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 25 Nov 2019 (estimated)
- Study completion
- 10 Dec 2019 (estimated)
- First posted
- 5 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| health control | – | –healthy controls are all from normal volunteers |
| splenectomy | – | Procedure: splenectomyTraumatic patients after total splenectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study Population are aged from 18 to 65 years，which divided into 2 groups: Splenectomy, healthy controls
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- Use antibiotics and probiotics 3 mouth before samples collection.
- Other severe abdomen injury
- Underwent abdomen organ resection surgery
- Other digestive system disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| splenectomyTraumatic patients who performed total splenectomy | Procedure or surgery | splenectomy |
Primary outcome
Transcriptional changes in gut microbiota
Time frame: 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
Time frame: Baseline, 6 months after surgery, 12 months after surgery, 24 months after surgery
Plasma LPS level will be measured by ELISA
4 secondary outcomes
Fecal SIgA
Time frame: Baseline, 6 months after surgery, 12 months after surgery, 24 months after surgery
Fecal calprotectin
Time frame: Baseline, 6 months after surgery, 12 months after surgery, 24 months after surgery
Plasma DAO
Time frame: Baseline, 6 months after surgery, 12 months after surgery, 24 months after surgery
Plasma D-Lac
Time frame: Baseline, 6 months after surgery, 12 months after surgery, 24 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei Yunwei study director
First Affiliated Hospital of Harbin Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gut Microbiota and Spleen Injury, run by First Affiliated Hospital of Harbin Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Yunwei (+86-0451-85553099, hydwyw11@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transcriptional changes in gut microbiota (time frame: Baseline, 6 months after surgery, 12 months after surgery, 24 months after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2019.