Interaction Between Non-typhoid Salmonella, Host Microbiota, and Immune System During Acute Infection and Remission
NCT ID: NCT03494101
Last Updated: 2018-07-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
40 participants
OBSERVATIONAL
2018-06-15
2020-01-31
Brief Summary
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Detailed Description
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During the study, longitudinal stool and blood samples will be collected from patients with a non-typhoid Salmonella infection at different study time points (2 weeks, 4 weeks and 6 months after positive Salmonella stool culture) and analyzed for changes in the microbiota, mutation rates in the Salmonella strains and the specific immune response evoked by the infection (e.g. anti-bodies). At each study time point clinical information will be investigated with a questionnaire to assess current symptoms, medication etc. Findings will be compared to healthy individuals and patients with acute, infectious diarrhea caused by other microorganisms than non-typhoid Salmonella.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Non-typhoid Salmonella infection
Patients with a non-typhoid Salmonella infection. Blood samples, stool samples and clinical information will be collected.
Blood samples
Blood samples will be collected and analyzed at different study time points
Stool samples
Stool samples will be collected and analyzed at different study time points
Clinical information
Clinical information will be collected at different study time points using questionnaires
Acute, infectious diarrhea
Patients with acute, infectious diarrhea without non-typhoid Salmonella infection. Blood samples, stool samples and clinical information will be collected.
Blood samples
Blood samples will be collected and analyzed at different study time points
Stool samples
Stool samples will be collected and analyzed at different study time points
Clinical information
Clinical information will be collected at different study time points using questionnaires
Healthy individuals
Healthy individuals with no symptoms of acute or chronic diarrhea. Blood samples, stool samples and clinical information will be collected.
Blood samples
Blood samples will be collected and analyzed at different study time points
Stool samples
Stool samples will be collected and analyzed at different study time points
Clinical information
Clinical information will be collected at different study time points using questionnaires
Interventions
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Blood samples
Blood samples will be collected and analyzed at different study time points
Stool samples
Stool samples will be collected and analyzed at different study time points
Clinical information
Clinical information will be collected at different study time points using questionnaires
Eligibility Criteria
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Inclusion Criteria
* Ability to understand and follow study procedures and understand informed consent
* Age 18-75 years.
* Acute diarrhea (≥3 bowel movements per day for ≤4 weeks)
* Stool cultures positive for non-typhoid Salmonella ≤4 weeks before inclusion
* Acute diarrhea (≥3 bowel movements per day for ≤4 weeks)
* Stool cultures negative for non-typhoid Salmonella infection within ≤ 4 weeks
• No symptoms of acute or chronic diarrhea (2 bowel movements per week to 2 per day)
Exclusion Criteria
* Medication with immunosuppressants (e.g. corticoids, biological therapy).
* Major medical/surgical/psychiatric condition requiring ongoing management. Minor well controlled conditions (i.e. medically controlled arterial hypertension, occupational asthma) may be present.
* Major diagnosis known to chronically affect gut microbiota (e.g. inflammatory bowel disease, liver cirrhosis, colon carcinoma, systemic sclerosis).
* Current diagnosis of a hematological disorder (e.g. severe anemia with hemoglobin \<7 g/dl, leukemia) or any other absolute contraindication for blood donation.
* Participation in other clinical study interfering with study procedures.
* Inability to understand study procedures in order to provide inform consent.
* Previous participation in the same study.
18 Years
75 Years
ALL
Yes
Sponsors
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University of Zurich
OTHER
Responsible Party
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Principal Investigators
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Benjamin Misselwitz, PD Dr.med.
Role: PRINCIPAL_INVESTIGATOR
Division of Gastroenterology, University Hospital Zurich Zurich, Switzerland, 8091
Locations
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Division of Gastroenterology, University Hospital Zurich
Zurich, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SALMONELLA Study
Identifier Type: -
Identifier Source: org_study_id
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