Evaluation of the Prevalence of Functional Digestive Disorders During Primary Sjögren Gougerot Syndrome (GASTRO-SGS)

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.

Study Overview

• Status: Completed
• Conditions: Sjogren's Syndrome; Digestive System Abnormalities
• Intervention / Treatment: Other: Global symptom score (GSS) questionary

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.

• Study Type: Interventional
• Enrollment (Actual): 151
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Limoges, France, 87042
    • University Hospital, Limoges

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Global symptom score (GSS) questionary; systematic research of digestive symptoms in patients with SGSp with Global symptom score (GSS) questionary.	Other: Global symptom score (GSS) questionary; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	19 months (End of study)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	19 months (End of study)
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	19 months (End of study)
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	19 months (End of study)
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	19 months (End of study)
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	19 months (End of study)

Collaborators and Investigators

• Sponsor: University Hospital, Limoges
• Investigators: Principal Investigator: ANNE-LAURE FAUCHAIS, PH, University Hospital, Limoges

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2017
• Primary Completion (Actual): June 28, 2018
• Study Completion (Actual): June 28, 2018

Study Registration Dates

• First Submitted: May 2, 2017
• First Submitted That Met QC Criteria: May 15, 2017
• First Posted (Actual): May 17, 2017

Study Record Updates

• Last Update Posted (Actual): September 13, 2018
• Last Update Submitted That Met QC Criteria: September 12, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Primary Sjögren syndrome - Digestive symptoms
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Eye Diseases; Disease; Congenital Abnormalities; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Stomatognathic Diseases; Mouth Diseases; Lacrimal Apparatus Diseases; Arthritis, Rheumatoid; Xerostomia; Salivary Gland Diseases; Dry Eye Syndromes; Syndrome; Digestive System Diseases; Sjogren's Syndrome; Digestive System Abnormalities
• Other Study ID Numbers: I16033 (GASTRO-SGS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No