Evaluation of the Prevalence of Functional Digestive Disorders During Primary Sjögren Gougerot Syndrome
GASTRO-SGS
1 other identifier
interventional
151
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 2, 2017
CompletedFirst Posted
Study publicly available on registry
May 17, 2017
CompletedStudy Start
First participant enrolled
July 17, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 28, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 28, 2018
CompletedApril 2, 2026
July 1, 2018
12 months
May 2, 2017
March 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Prevalence of each GSS symptom
19 months (End of study)
Prevalence of stomach digestive symptoms
19 months (End of study)
Association between the presence of digestive disorders and SGSp activity
19 months (End of study)
Association between the presence of digestive symptoms, the existence of a sicca syndrome at the time of screening
19 months (End of study)
Digestive disorders
19 months (End of study)
Study Arms (1)
Global symptom score (GSS) questionary
EXPERIMENTALsystematic research of digestive symptoms in patients with SGSp with Global symptom score (GSS) questionary.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital, Limoges
Limoges, 87042, France
Related Publications (1)
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.
PMID: 33468262RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
ANNE-LAURE FAUCHAIS, PH
University Hospital, Limoges
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 2, 2017
First Posted
May 17, 2017
Study Start
July 17, 2017
Primary Completion
June 28, 2018
Study Completion
June 28, 2018
Last Updated
April 2, 2026
Record last verified: 2018-07
Data Sharing
- IPD Sharing
- Will not share