Systemic SclerosisSCLEROMICROBIONCT04791280
Study of the Intestinal Microbiota of Patients With Systemic Sclerosis
An observational study of Systemic Sclerosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The term gut microbiota describes the entire intestinal microbial communities. Studies have established the important role played by the gut microbiome in modulating vital functions of the healthy host. The physiological effects of the microbiota for the host are, for the most part, beneficial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Sclerosis
- What is being tested?
- Faeces collection
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 31 Mar 2021to Sep 2023
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Patients with systemic sclerosis treated in the Internal Medicine Department of Saint Antoine Hospital and patients who will be newly diagnosed within 2 years after the beginning of the biological collection.
Who may be able to join
- Age ≥ 18 years old
- Patient with a confirmed diagnosis of systemic sclerosis according to international criteria, before or after the start date of this study.
- Non-opposition of the patient
Who cannot join
- Subject under guardianship, curatorship or safeguard of justice
- Subject with state medical aid (AME)
- Subject does not speak French
- Subject unable to answer questions or express himself/herself
- Taking antibiotics or a colonic preparation within 6 weeks prior to stool collection will be a temporary contraindication to stool collection. The patient may be included, other usual care samples may be taken, but the stool sample will be deferred and taken at a later date.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hopital Saint Antoine - service de médecine interne
Paris, 75012
Arsène MEKINIAN, Professor, 01 48 72 89 80, arsene.mekinian@aphp.fr
Harry SOKOL, Professor, 01 49 28 31 62, harry.sokol@aphp.fr
About this study
The term gut microbiota describes the entire intestinal microbial communities. Studies have established the important role played by the gut microbiome in modulating vital functions of the healthy host. The physiological effects of the microbiota for the host are, for the most part, beneficial. In several pathologies, an imbalance in the composition of the microbiota has been demonstrated.
Systemic sclerosis is an autoimmune, disorder of the connective tissue, characterized by vascular lesions, immunological abnormalities, and fibrosis of skin and internal organs As in many inflammatory diseases, there are painful digestive manifestations in systemic scleroderma that affect up to 90% of patients. The exact pathophysiology of the digestive involvement in systemic sclerosis is uncertain. The digestive manifestations of systemic sclerosis are frequent and can affect the entire digestive system.
Read more
However, there are few studies of the intestinal microbiota in this disease, which seems to be part of the same continuum of diseases with abnormalities of innate immunity. By analogy with chronic inflammatory bowel diseases, particularly Crohn's disease, we have raised the question of the existence of dysbiosis during scleroderma which could lead to episodes of acute, severe and recurrent inflammation of the peritoneum under the influence of triggering factors. The long-term prospects would be to look for ways to prevent attacks or to treat them more rapidly and effectively by using therapeutic targets in the intestinal microbiota.
The study population will be seen in the usual care setting, identically to all patients with systemic sclerosis treated in the department.
In case of an inflammatory disease outbreak, and depending on its severity, the patient will be seen again in consultation or hospitalized. Appropriate complementary examinations (biology, imaging, endoscopy) will be carried out and the treatment adapted.
- Conditions
- Systemic Sclerosis
- Being tested
- Faeces collection
- Keywords
- Gut microbiota, Systemic sclerosis
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Faeces collectionProcedure or surgery
- faeces collection at inclusion
- follow-up visit 6 months after inclusion
| Study group | Role | What they receive |
|---|---|---|
| patients with systemic sclerosis | On the day of inclusion, the faeces collection will be carried out by the patient using adapted equipment, either at the hospital or at home. In the case of a home collection, it will be carried out on the day of a planned hospital and preserved using equipment provided and tested to maintain the quality of the collection before storage.
6 months after inclusion (+/- 2 months) a follow-up visit will be carried out and the patient will perform a second faecal sample.
At the inclusion visit and at M6 the UCLA SCTC GIT 2.0 questionnaire will be completed by the patient. Receives: Procedure: Faeces collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of dysbiosis
to study the prevalence of dysbiosis in patients with systemic sclerosis treated in the internal medicine department of St. Antoine Hospital in order to investigate prognostic biological parameters of disease progression, response to treatment and the occurrence of intestinal and extra-intestinal complications.
Measured: Throughout the whole study, up to 6 months
Secondary outcomes (3)
Microbiota composition and diversity assessed by 16s sequencing
To study the differences in microbiota according to the disease and its evolution under immunomodulating treatments.
Measured: Throughout the whole study, up to 6 months
The fecal bacterial composition in comparison to different subtypes of systemic sclerosis and evolution during the time
To compare the markers of the intestinal microbiota between patients of this study and patients with IBD treated in in the Gastroenterology and Nutrition Department of St Antoine Hospital (existing biological collection SUIVITHEQUE).
Measured: Throughout the whole study, up to 6 months
Microbiota correlation
To correlate microbiota abnormalities with disease progression, occurrence of intestinal and extraintestinal complications
Measured: Throughout the whole study, up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start31 Mar 2021
- Primary completionSep 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic SclerosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arsène MEKINIAN, professor, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04791280
- Sponsor's protocol ID
- APHP201046
- Acronym
- SCLEROMICROBIO
- Status last verified
- Jun 2022
- First submitted
- 15 Feb 2021
- Last updated
- 21 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Intestinal Microbiota of Patients With Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT04791280
- Acronym / sponsor ID
- SCLEROMICROBIO / APHP201046
- Conditions
- Systemic Sclerosis
- Keywords
- Gut microbiota, Systemic sclerosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 31 Mar 2021 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 10 Mar 2021 (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 term gut microbiota describes the entire intestinal microbial communities. Studies have established the important role played by the gut microbiome in modulating vital functions of the healthy host. The physiological effects of the microbiota for the host are, for the most part, beneficial. In several pathologies, an imbalance in the composition of the microbiota has been demonstrated.
Systemic sclerosis is an autoimmune, disorder of the connective tissue, characterized by vascular lesions, immunological abnormalities, and fibrosis of skin and internal organs As in many inflammatory diseases, there are painful digestive manifestations in systemic scleroderma that affect up to 90% of patients. The exact pathophysiology of the digestive involvement in systemic sclerosis is uncertain. The digestive manifestations of systemic sclerosis are frequent and can affect the entire digestive system.
However, there are few studies of the intestinal microbiota in this disease, which seems to be part of the same continuum of diseases with abnormalities of innate immunity. By analogy with chronic inflammatory bowel diseases, particularly Crohn's disease, we have raised the question of the existence of dysbiosis during scleroderma which could lead to episodes of acute, severe and recurrent inflammation of the peritoneum under the influence of triggering factors. The long-term prospects would be to look for ways to prevent attacks or to treat them more rapidly and effectively by using therapeutic targets in the intestinal microbiota.
The study population will be seen in the usual care setting, identically to all patients with systemic sclerosis treated in the department.
In case of an inflammatory disease outbreak, and depending on its severity, the patient will be seen again in consultation or hospitalized. Appropriate complementary examinations (biology, imaging, endoscopy) will be carried out and the treatment adapted.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with systemic sclerosis | – | Procedure: Faeces collectionOn the day of inclusion, the faeces collection will be carried out by the patient using adapted equipment, either at the hospital or at home. In the case of a home collection, it will be carried out on the day of a planned hospital and preserved using equipment provided and tested to maintain the quality of the collection before storage. 6 months after inclusion (+/- 2 months) a follow-up visit will be carried out and the patient will perform a second faecal sample. At the inclusion visit and at M6 the UCLA SCTC GIT 2.0 questionnaire will be completed by the patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with systemic sclerosis treated in the Internal Medicine Department of Saint Antoine Hospital and patients who will be newly diagnosed within 2 years after the beginning of the biological collection.
Key inclusion criteria (3 listed)
- Age ≥ 18 years old
- Patient with a confirmed diagnosis of systemic sclerosis according to international criteria, before or after the start date of this study.
- Non-opposition of the patient
Key exclusion criteria (5 listed)
- Subject under guardianship, curatorship or safeguard of justice
- Subject with state medical aid (AME)
- Subject does not speak French
- Subject unable to answer questions or express himself/herself
- Taking antibiotics or a colonic preparation within 6 weeks prior to stool collection will be a temporary contraindication to stool collection. The patient may be included, other usual care samples may be taken, but the stool sample will be deferred and taken at a later date.
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 |
|---|---|---|
| Faeces collection* faeces collection at inclusion * follow-up visit 6 months after inclusion | Procedure or surgery | patients with systemic sclerosis |
Primary outcome
Prevalence of dysbiosis
Time frame: Throughout the whole study, up to 6 months
to study the prevalence of dysbiosis in patients with systemic sclerosis treated in the internal medicine department of St. Antoine Hospital in order to investigate prognostic biological parameters of disease progression, response to treatment and the occurrence of intestinal and extra-intestinal complications.
3 secondary outcomes
Microbiota composition and diversity assessed by 16s sequencing
Time frame: Throughout the whole study, up to 6 months
The fecal bacterial composition in comparison to different subtypes of systemic sclerosis and evolution during the time
Time frame: Throughout the whole study, up to 6 months
Microbiota correlation
Time frame: Throughout the whole study, up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
- 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.
Arsène MEKINIAN, professor principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Sclerosis, run by Assistance Publique - Hôpitaux de Paris 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: status not confirmed, as of the sponsor's last update on 21 Jun 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arsène MEKINIAN, Professor (01 48 72 89 80, arsene.mekinian@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of dysbiosis (time frame: Throughout the whole study, up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jun 2022.