Interaction Between Non-typhoid Salmonella, Host Microbiota, and Immune System During Acute Infection and Remission

NCT03494101 | Unknown

• 1 other identifier: SALMONELLA Study
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Stool and blood samples from patients with a non-typhoid Salmonella infection will be collected during an observation period of six months and analyzed for changes in the microbiota diversity and composition, mutation rates in the Salmonella strains and the specific immune response evoked by the infection. Findings are compared to healthy individuals and individuals with acute, infectious diarrhea caused by other microorganisms.

Conditions

Salmonella Infection Non-Typhoid

Outcome Measures

Primary Outcomes (1)

• Genomic mutations in non-typhoid Salmonella strains

  Analyze the evolution of non-typhoid Salmonella during acute infection and remission in humans. The primary variable of interest is the number of observed genomic mutations in non-typhoid Salmonella strains.

  4 weeks after index stool culture

Secondary Outcomes (10)

• Quantification of non-typhoid Salmonella genes associated with: tissue invasion, antibiotic resistance and virulence factors

  4 weeks after index stool culture

• Identification of most frequently mutated surface antigenes of non-typhoid Salmonella

  4 weeks after index stool culture

• Gen Cluster Expression

  2 weeks, 4 weeks and 6 months after index stool culture

• Mutated non-typhoid Salmonella strains

  4 weeks and 6 months after index stool culture

• Microbiota changes

  2 weeks, 4 weeks and 6 months after index stool culture

Study Arms (3)

Non-typhoid Salmonella infection

Patients with a non-typhoid Salmonella infection. Blood samples, stool samples and clinical information will be collected.

Other: Blood samples; Other: Stool samples; Other: Clinical information

Acute, infectious diarrhea

Patients with acute, infectious diarrhea without non-typhoid Salmonella infection. Blood samples, stool samples and clinical information will be collected.

Other: Blood samples; Other: Stool samples; Other: Clinical information

Healthy individuals

Healthy individuals with no symptoms of acute or chronic diarrhea. Blood samples, stool samples and clinical information will be collected.

Other: Blood samples; Other: Stool samples; Other: Clinical information

Interventions

Blood samples OTHER

Blood samples will be collected and analyzed at different study time points

Acute, infectious diarrhea; Healthy individuals; Non-typhoid Salmonella infection

Stool samples OTHER

Stool samples will be collected and analyzed at different study time points

Acute, infectious diarrhea; Healthy individuals; Non-typhoid Salmonella infection

Clinical information OTHER

Clinical information will be collected at different study time points using questionnaires

Acute, infectious diarrhea; Healthy individuals; Non-typhoid Salmonella infection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

20 patients with a non-typhoid Salmonella infection, 10 patients with acute, infectious diarrhea without non-typhoid Salmonella infection, 10 healthy individuals

You may qualify if:

• Signed informed consent.
• 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)
• 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)

You may not qualify if:

• Current use of antibiotics
• 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.

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

Division of Gastroenterology, University Hospital Zurich

Zurich, 8091, Switzerland

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood and stool samples

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Benjamin Misselwitz, PD Dr.med.

  Division of Gastroenterology, University Hospital Zurich Zurich, Switzerland, 8091

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Benjamin Misselwitz, PD Dr.med.

CONTACT

+41 44 255 1111; benjamin.misselwitz@usz.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2018
• First Posted: April 11, 2018
• Study Start: June 15, 2018
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: July 3, 2018

Record last verified: 2018-06

Locations

CH (1)