Scleroderma. Systemic sclerosis [scleroderma]
Conditions
Interventions
Intervention 1: Control group: The probiotic capsule (LactoCare) and placebo are prepared by the Tehran Biotechnology Company. The probiotic capsule is completely similar to the placebo in terms of sh
Sponsors
Mashhad University of Medical Sciences
Eligibility
Sex/Gender
All
Age
20 Years to 65 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Interferon delta. Timepoint: At the beginning of the study (before the intervention) and 2 months after starting probiotic consumption. Method of measurement: Blood sampling from the brachial vein with 5 cc of blood to prepare serum for ELISA test.;Interleukin 4. Timepoint: At the beginning of the study (before the intervention) and 2 months after starting probiotic consumption. Method of measurement: Blood sampling from the brachial vein with 5 cc of blood to prepare serum for ELISA test.;Interleukin 10. Timepoint: At the beginning of the study (before the intervention) and 2 months after starting probiotic consumption. Method of measurement: Blood sampling from the brachial vein with 5 cc of blood to prepare serum for ELISA test.;Interleukin 17. Timepoint: At the beginning of the study (before the intervention) and 2 months after starting probiotic consumption. Method of measurement: Blood sampling from the brachial vein with 5 cc of blood to prepare serum for ELISA test.;Reflux. Timepoint: At the beginning of the study (before the intervention) and 2 months after starting probiotic consumption. Method of measurement: The University of California Los Angeles Scleroderma Clinical Trials Consortium gastrointestinal tract 2.0 (UCLA GIT 2.0) questionnaire.;Distention/bloating. Timepoint: At the beginning of the study (before the intervention) and 2 months after starting probiotic consumption. Method of measurement: UCLA GIT 2.0 Questionnaire.;Fecal soilage. Timepoint: At the beginning of the study (before the intervention) and 2 months after starting probiotic consumption. Method of measurement: UCLA GIT 2.0 Questionnaire.;Diarrhea. Timepoint: At the beginning of the study (before the intervention) and 2 months after starting probiotic consumption. Method of measurement: UCLA GIT 2.0 Questionnaire.;Social functioning. Timepoint: At the beginning of the study (before the intervention) and 2 months after starting probiotic consumption. Method of measurement: UCLA GIT 2. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactHossein Ghazaee
Mashhad University of Medical Sciences
Outcome results
None listed