Evaluation of the Prevalence of Functional Digestive Disorders During Primary Sjögren Gougerot Syndrome (GASTRO-SGS)
Primary Purpose
Sjogren's Syndrome, Digestive System Abnormalities
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Global symptom score (GSS) questionary
Sponsored by
About this trial
This is an interventional basic science trial for Sjogren's Syndrome focused on measuring Primary Sjögren syndrome - Digestive symptoms
Eligibility Criteria
Inclusion Criteria:
- Patients with SGSp according to revised American-European criteria
- Patients 18 years of age or older
- Patients affiliated to the French social security care system.
Exclusion Criteria:
- Patients under measure of maintenance of justice.
- Patients unable to understand or to participate to the study.
- Child and major patients making the object of a measure of lawful protection.
- Patients deprived of freedom.
- Concomitant interventional clinical trial
Sites / Locations
- University Hospital, Limoges
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Global symptom score (GSS) questionary
Arm Description
systematic research of digestive symptoms in patients with SGSp with Global symptom score (GSS) questionary.
Outcomes
Primary Outcome Measures
Prevalence of functional digestive symptoms during SGSp
Measure the prevalence of functional digestive symptoms during SGSp globally and as a function of the duration of the disease
Secondary Outcome Measures
Prevalence of each GSS symptom
Measure the prevalence of each GSS symptom and its severity during the pSGS, globally and depending on the duration of disease
Prevalence of stomach digestive symptoms
Measure the prevalence of each GSS symptom and its severity during the pSGS, globally and depending on the duration of disease
Association between the presence of digestive disorders and SGSp activity
Determine the possible association between the presence of digestive disorders (each symptom) and SGSp activity, painfulness experienced by the patient, anti-SSA antibody, and / or SSB
Association between the presence of digestive symptoms, the existence of a sicca syndrome at the time of screening
Determine the possible association between the presence of digestive symptoms, the existence of a sicca syndrome at the time of screening, neurological involvement, pulmonary involvement, parotiditis, depressive disorders, fibromyalgia, hypergammaglobulinemia
Digestive disorders
Describe the digestive disorders discovered by the digestive explorations generated by the existence of digestive symptoms, in accordance with the usual rules of good practice
Full Information
NCT ID
NCT03157011
First Posted
May 2, 2017
Last Updated
September 12, 2018
Sponsor
University Hospital, Limoges
1. Study Identification
Unique Protocol Identification Number
NCT03157011
Brief Title
Evaluation of the Prevalence of Functional Digestive Disorders During Primary Sjögren Gougerot Syndrome
Acronym
GASTRO-SGS
Official Title
Evaluation of the Prevalence of Functional Digestive Disorders During Primary Sjögren Gougerot Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
July 17, 2017 (Actual)
Primary Completion Date
June 28, 2018 (Actual)
Study Completion Date
June 28, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Limoges
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
the investigators propose to carry out a prospective study consisting of a systematic research of digestive symptoms in patients with SGSp with the validated Global symptom score (GSS) questionnaire, which allowed to grades severity of 10 digestive symptoms (absent, mild, moderate, or severe), asthenia and fever.
Detailed Description
Primary Sjögren syndrome (SGSp) is an autoimmune disease defined by the association of sicca syndrome in the absence of other connective tissues (ie rheumatoid arthritis, systemic lupus erythematosus, scleroderma, dermatopolymyositis). SGSp is complicated by several visceral involvements (pulmonary, renal, neurological, systemic vasculitis ...) and by a chronic alteration of the quality of life related to asthenia, chronic pain and sicca syndrome. Two European-validated scales are currently used in daily clinical practice to assess these two facets of the disease, respectively EUSSAR Sjogren's Syndrome Patient Reported Index (ESSPRI) and ESSDAI (EULAR Sjögren's Syndrome Disease Activity Index). Neither of these two scores evaluate the digestive impairment. Indeed, digestive complaints have been evaluated in a few studies, with a prevalence of 30 to 65%. The precise etiopathogeny of such digestive involvements remains unknown.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sjogren's Syndrome, Digestive System Abnormalities
Keywords
Primary Sjögren syndrome - Digestive symptoms
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Global symptom score (GSS) questionary . This questionnaire has the advantage of grading the severity of These digestive symptoms.
Masking
None (Open Label)
Allocation
N/A
Enrollment
151 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Global symptom score (GSS) questionary
Arm Type
Experimental
Arm Description
systematic research of digestive symptoms in patients with SGSp with Global symptom score (GSS) questionary.
Intervention Type
Other
Intervention Name(s)
Global symptom score (GSS) questionary
Intervention Description
systematic research of digestive symptoms in patients with SGSp with Global symptom score (GSS) questionary, which allowed to grades severity of 10 digestive symptoms (absent, mild, moderate, or severe), asthenia and fever.
Primary Outcome Measure Information:
Title
Prevalence of functional digestive symptoms during SGSp
Description
Measure the prevalence of functional digestive symptoms during SGSp globally and as a function of the duration of the disease
Time Frame
19 months (End of study)
Secondary Outcome Measure Information:
Title
Prevalence of each GSS symptom
Description
Measure the prevalence of each GSS symptom and its severity during the pSGS, globally and depending on the duration of disease
Time Frame
19 months (End of study)
Title
Prevalence of stomach digestive symptoms
Description
Measure the prevalence of each GSS symptom and its severity during the pSGS, globally and depending on the duration of disease
Time Frame
19 months (End of study)
Title
Association between the presence of digestive disorders and SGSp activity
Description
Determine the possible association between the presence of digestive disorders (each symptom) and SGSp activity, painfulness experienced by the patient, anti-SSA antibody, and / or SSB
Time Frame
19 months (End of study)
Title
Association between the presence of digestive symptoms, the existence of a sicca syndrome at the time of screening
Description
Determine the possible association between the presence of digestive symptoms, the existence of a sicca syndrome at the time of screening, neurological involvement, pulmonary involvement, parotiditis, depressive disorders, fibromyalgia, hypergammaglobulinemia
Time Frame
19 months (End of study)
Title
Digestive disorders
Description
Describe the digestive disorders discovered by the digestive explorations generated by the existence of digestive symptoms, in accordance with the usual rules of good practice
Time Frame
19 months (End of study)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with SGSp according to revised American-European criteria
Patients 18 years of age or older
Patients affiliated to the French social security care system.
Exclusion Criteria:
Patients under measure of maintenance of justice.
Patients unable to understand or to participate to the study.
Child and major patients making the object of a measure of lawful protection.
Patients deprived of freedom.
Concomitant interventional clinical trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ANNE-LAURE FAUCHAIS, PH
Organizational Affiliation
University Hospital, Limoges
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital, Limoges
City
Limoges
ZIP/Postal Code
87042
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33468262
Citation
Parreau S, Jacques J, Dumonteil S, Palat S, Geyl S, Gondran G, Bezanahary H, Liozon E, Azais J, Colombie S, Jauberteau MO, Loustaud-Ratti V, Ly KH, Fauchais AL. Abdominal symptoms during Sjogren's syndrome: a pilot study. Adv Rheumatol. 2021 Jan 19;61(1):5. doi: 10.1186/s42358-021-00164-w.
Results Reference
derived
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Evaluation of the Prevalence of Functional Digestive Disorders During Primary Sjögren Gougerot Syndrome
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