Primary objective: To identify specific bacteria or a characteristic bacterial composition in the oral and gut microbiome of pSS patients compared to non-Sjögren*s syndrome sicca (non-SS sicca) patients, SLE patients and healthy controls.Secondary…
ID
Source
Brief title
Condition
- Other condition
- Autoimmune disorders
Synonym
Health condition
rheumatische aandoeningen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Mouth wash, buccal swab and stool samples
Microbiome data:
• Relative abundance; quantitative measure of the number of micro-organisms,
operational taxonomic units (OTUs), or sequences detected in a sample, in
relation to all other micro-organisms in the same sample.
• Richness; the number of unique organisms detected in one sample.
• Diversity; (measured with the species richness and abundance) within
(alpha-diversity) and between (beta-diversity) samples.
• Distance; a measure of the differences between samples (conducting principal
component analysis) based on beta-diversity.
• UniFrac phylogenetic distance; the phylogenetic distance between sets of taxa
in a phylogenetic tree as the fraction of the branch length of the tree that
leads to descendants from either one environment or the other, but not both.
Laboratory parameters:
• Levels of IgA and IgM in mouth wash and stool samples
Secondary outcome
- Dutch Periodontal Screening Index score (DPSI score)
- Food consumption
- Data on perinatal period (birth weight and length, type of delivery,
breastfeeding y/n) (6 questions)
- Xerostomia Inventory (11 questions)
- WHO Oral Health questionnaire for adults (16 questions)
Background summary
Sjögren*s syndrome (SS) is one of the three most common auto-immune disorders.
SS is characterized by infiltration of lymphocytes in the salivary and lacrimal
glands leading to a reduced secretion of saliva and tears which in turn leads
to sicca symptoms of the mouth and eyes. Primary SS (pSS) is a multifactorial
disease because genes, environment, ductal gland epithelial cells and an
altered immune system play important roles in the pathogenesis. Bacteria in the
human gut affect the local and systemic immune system of the host. A dysbiosis
or specific bacteria can induce a chronic inflammatory reaction and may cause
autoimmunity in the host. Associations between specific gut microbiota and
rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE) have been
found in clinical studies. We will investigate whether pSS is associated with
changes in the microbial composition in the gut and the oral cavity.
Study objective
Primary objective: To identify specific bacteria or a characteristic bacterial
composition in the oral and gut microbiome of pSS patients compared to
non-Sjögren*s syndrome sicca (non-SS sicca) patients, SLE patients and healthy
controls.
Secondary objective: To associate characteristics of the oral and gut
microbiome of pSS patients with clinical, functional, laboratory and
histological parameters of pSS.
Study design
The Sjögren microbiome study has an observational case-control design.
Four study groups are included:
1) Patients with pSS: 30
2) Non-SS sicca patients: 30
3) SLE patients: 30
4) Healthy controls: 100
Study burden and risks
Patients with pSS and non-SS sicca patients who visit the outpatient clinic of
the department of Rheumatology and Clinical Immunology and the department of
OMF-Surgery as part of the *UMCG zorgtraject Sjögren* will be asked to
participate in the Sjögren microbiome study. The UMCG zorgtraject Sjögren is a
standardized diagnostic work-up protocol in which patients who are suspected to
have SS routinely visit the Rheumatology and Immunology department, the
department of OMF-Surgery and the department of Ophthalmology. Patients with
SLE will be informed about this study two weeks prior to their outpatient
clinic visit. No extra visits to the hospital are required for any of the
participants of this study. Extra interventions of the Sjögren microbiome study
are: one mouth wash sample, one buccal swab and one stool sample (collected by
the patient at home), 4 questionnaires and a short periodontal condition
examination. Overall, the burden for the participants is low, because no extra
visits are necessary, samples are collected only once and at home and the
sampling methods are non-invasive. The risk of participation is negligible as
no invasive procedures specifically for this research project will be
performed. Patients do not have a direct benefit of participating in the study.
However, with the results obtained in this study we will create a foundation
for future research on the role of the oral and gut microbiome in pSS and SLE
patients. This may lead to new insights in pathogenesis and new ways of
treating pSS and SLE.
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL51722.042.15 |