Probiotic effect on scleroderma
Phase 3
Recruiting
- Conditions
- Scleroderma.Systemic sclerosis [scleroderma]
- Registration Number
- IRCT20240115060698N1
- Lead Sponsor
- Mashhad University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 44
Inclusion Criteria
Diagnosis of scleroderma based on ACR-Eular criteria
Patients aged 20 to 65 years
Scleroderma patients with malabsorption symptoms such as bloating, bowel dysfunction, cyclic constipation and diarrhea, heartburn
If taking corticosteroids, they have not changed the dose of corticosteroids in the past month.
Exclusion Criteria
Pregnancy
Breastfeeding
Active infection
New organ involvement
Irritable bowel disease
Malignancy
Inflammatory bowel disease (IBD) and ulcerative colitis (UC)
Antibiotic intake in past 2 weeks
Probiotic intake in past 4 weeks
Endoxan in past 4 weeks
Rituximab in past 4 weeks
Biologic drugs in past 4 weeks
Medication changes in 2 month period of follow-up
Overlap syndromes
Voluntary withdrawal from the study
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method