Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2025-12-24 @ 2:52 PM
NCT ID:
NCT01804959
Eligibility Criteria:
Inclusion Criteria:
* SSc that fulfills the American College of Rheumatology (ACR, 1990) classification criteria or the proposed European League Against Rheumatism (EULAR) criteria for very early diagnosis of systemic sclerosis.
* SSc overlap syndromes (ie SSc occurring in overlap with other connective tissue diseases)
* SSc-associated GI symptoms (heartburn, dysphagia, vomiting, bloating/distension, faecal soilage, diarrhoea, constipation) not due to other causes as determined by clinical evaluation, with a total GIT score of at least 0.10
* Stable doses of immunosuppressive treatment, corticosteroids, and GI medications for 30 days.
Exclusion Criteria:
* On anti-biotics or probiotics within the last 30 days
* Current serious infections requiring hospitalization
* Long-term indwelling catheter, including patients on total parenteral nutrition
* Females who are lactating or pregnant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01804959
Study Brief:
Protocol Section:
NCT01804959