Sjogren's SyndromeGASTRO-SGSNCT03157011
Evaluation of the Prevalence of Functional Digestive Disorders During Primary Sjögren Gougerot Syndrome
A study testing Global symptom score (GSS) questionary in people with Sjogren's Syndrome and Digestive System Abnormalities, run by University Hospital, Limoges at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sjogren's Syndrome, Digestive System Abnormalities
- What is being tested?
- Global symptom score (GSS) questionary
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jul 2017to 28 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Sjogren's Syndrome, Digestive System Abnormalities
- Being tested
- Global symptom score (GSS) questionary
- Keywords
- Primary Sjögren syndrome - Digestive symptoms
- Medical subject headings
- Sjogren's Syndrome, Digestive System Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Global symptom score (GSS) questionaryOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Global symptom score (GSS) questionary | Experimental | systematic research of digestive symptoms in patients with SGSp with Global symptom score (GSS) questionary. Receives: Other: Global symptom score (GSS) questionary |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 19 months (End of study)
Secondary outcomes (5)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 19 months (End of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study start17 Jul 2017
- Primary completion28 Jun 2018
- Study completion28 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sjogren's SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Global symptom score (GSS) questionary . This questionnaire has the advantage of grading the severity of These digestive symptoms.
- Masking
- None (open label)
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ANNE-LAURE FAUCHAIS, PH, Principal investigator, University Hospital, Limoges
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03157011
- Sponsor's protocol ID
- I16033 (GASTRO-SGS)
- Acronym
- GASTRO-SGS
- Status last verified
- Jul 2018
- First submitted
- 2 May 2017
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 33468262
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Prevalence of Functional Digestive Disorders During Primary Sjögren Gougerot Syndrome
- ClinicalTrials.gov ID
- NCT03157011
- Acronym / sponsor ID
- GASTRO-SGS / I16033 (GASTRO-SGS)
- Conditions
- Sjogren's Syndrome, Digestive System Abnormalities
- Keywords
- Primary Sjögren syndrome - Digestive symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- 17 Jul 2017 (actual)
- Primary completion
- 28 Jun 2018 (actual)
- Study completion
- 28 Jun 2018 (actual)
- First posted
- 17 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Global symptom score (GSS) questionary . This questionnaire has the advantage of grading the severity of These digestive symptoms.
| Arm | Type | Receives |
|---|---|---|
| Global symptom score (GSS) questionary | Experimental | Other: Global symptom score (GSS) questionarysystematic research of digestive symptoms in patients with SGSp with Global symptom score (GSS) questionary. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Global symptom score (GSS) questionarysystematic 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. | Other | Global symptom score (GSS) questionary |
Primary outcome
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
5 secondary outcomes
Prevalence of each GSS symptom
Time frame: 19 months (End of study)
Prevalence of stomach digestive symptoms
Time frame: 19 months (End of study)
Association between the presence of digestive disorders and SGSp activity
Time frame: 19 months (End of study)
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)
Digestive disorders
Time frame: 19 months (End of study)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Results publication: PubMed 33468262Parreau 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ANNE-LAURE FAUCHAIS, PH principal investigator
University Hospital, Limoges
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Global symptom score (GSS) questionary in people with Sjogren's Syndrome and Digestive System Abnormalities, run by University Hospital, Limoges at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of functional digestive symptoms during SGSp (time frame: 19 months (End of study)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03157011, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.