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Completed

NCT Number: NCT03157011

Evaluation of the Prevalence of Functional Digestive Disorders During Primary Sjögren Gougerot Syndrome

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Global symptom score (GSS) questionary

Other

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 outcomes

  1. Prevalence of functional digestive symptoms during SGSp

    Time frame: 19 months (End of study)

    Measure the prevalence of functional digestive symptoms during SGSp globally and as a function of the duration of the disease

Secondary outcomes

  1. Prevalence of each GSS symptom

    Time frame: 19 months (End of study)

    Measure the prevalence of each GSS symptom and its severity during the pSGS, globally and depending on the duration of disease

  2. Prevalence of stomach digestive symptoms

    Time frame: 19 months (End of study)

    Measure the prevalence of each GSS symptom and its severity during the pSGS, globally and depending on the duration of disease

  3. Association between the presence of digestive disorders and SGSp activity

    Time frame: 19 months (End of study)

    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

  4. Association between the presence of digestive symptoms, the existence of a sicca syndrome at the time of screening

    Time frame: 19 months (End of study)

    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

  5. Digestive disorders

    Time frame: 19 months (End of study)

    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

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Registry information

Acronym: GASTRO-SGS

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 17, 2017
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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