The oral and gut microbiome in patients with primary Sjögren's syndrome - a pilot study

Completed

• Conditions: rheumatische aandoeningen; Primary Sjögren's syndrome; Sjögren; 10003816

• Registration Number: NL-OMON41780
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 90

Inclusion Criteria

In order to be eligible to participate in this study, all subjects must meet all of the following criteria:
• Age >= 18 years
• Live in Groningen, Friesland or Drenthe
• Signed informed consent;Subjects must meet the following criteria to be included in one of the four study groups:
• Group 1: Confirmed diagnosis of pSS according to the AECG criteria [4] after complete diagnostic workup.;• Group 2: non-SS sicca. After complete diagnostic workup defined as:
o Presence of symptoms of dry eyes and/or symptoms of a dry mouth according to the questions in the AECG criteria (supplement 15.1)
o Negative minor salivary gland biopsy according to the Chisholm and Mason scoring system(30)
o Absence of anti-Ro/La (SSA/SSB) auto-antibodies
o Low clinical suspicion of pSS;• Group 3: Newly diagnosed SLE patients. After excluding alternative diagnoses, SLE is diagnosed in patients who fulfill the 1997 American College of Rheumatology (ACR) criteria or the 2012 Systemic Lupus International Collaborating Clinics (SLICC) criteria.
o Disease duration of a maximum of 1 year;• Group 4: Healthy controls from the LifeLines Deep cohort. Healthy is defined as:
o No chronic illness of any kind (cardiovascular, cancer, renal / liver failure, etc. etc.)
o No use of immunosuppressive medication

Exclusion Criteria

A potential subject for the Sjögren Microbiome study who meets any of the following criteria will be excluded from participation:
* Presence of other systemic auto-immune connective tissue disease than SS or SLE (i.e., RA or systemic sclerosis)
* Presence of IgG4-related disease, Hepatitis C, HIV, sarcoidosis, amyloidosis, active TBC, graft versus host disease
* Past head and neck radiation treatment
* Subjects who are impaired, incapacitated, or incapable of completing cohort-related assessments such as a questionnaire
* Serious comorbidity or laboratory abnormalities that, in the opinion of the investigator, unacceptably increases the burden of participation in the study
* Severe psychiatric or physical illness
* Following an extreme diet (e.g. parenteral nutrition or macrobiotic diet)
* Use of antibiotics within the previous two months
* Use of immunosuppressive medication
* Gastro-enteritis when taking the stool sample

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified