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IRCT20240115060698N1 IRCT 2024-01-28 Mashhad University of Medical Sciences Probiotic effect on scleroderma The assessment of probiotics' effects on gastrointestinal inflammation and symptoms in patients with scleroderma 2024-02-20 anticipated 44 Complete https://irct.ir/trial/75007 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, block randomization with 11 blocks of 4 will be performed. We will use Excel software and the (rand) function to prepare random orders. The steps to perform block randomization using Excel are: 1- Create a group column with A, A, B, B, C, C. 2- In another column: assign random numbers to each letter with =rand(). While doing this, use "paste values" to stop the random recalculation 3- Sort the random numbers from lowest to highest by selecting expansion of choice 4- Copy the group column and paste it into the sequence column 5- Repeat the above steps 11 times 6- Finish: save A unique numerical code will be assigned to each of the randomly generated sequences. The randomization will be done by the statistical consultant of the study and the information will only be available to the study colleague at the time of intervention, Blinding description: All patients and physicians evaluating the interventions designed in the study or the outcomes after performing the intervention ( rheumatology assistant and rheumatologist) will not be informed of the group in which the patient under study is located. All interventions in both groups will be similarly designed and the process will be the same for all samples in all groups. The drugs used will also be supplied in similar shapes and packaging so that no one can identify the study group during the course of the study. 3 Scleroderma. 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 shape, color, and size, and patients consume one capsule of the placebo daily for two months. Intervention 2: Intervention group: The probiotic capsule (LactoCare) and placebo are prepared by the Tehran Biotechnology Company. Each LactoCare capsule contains 21 milligrams of Fructooligosaccharides (FOS). Patients receive one capsule daily for 2 months. This capsule contains 10^9^ CFU of Lactobacillus ruteri, Lactobacillus rhamnosus, and Bifidobacterium bacteria. Yes - There is a plan to make this available What will be shared: Information related to the main purpose of the study and data related to it is available for sharing When: Starting accessibility 6 months after publication To whom: Researchers from universities and scientific institutions and people who are engaged in industry Conditions: The data could be used in clinical and research intentions Where to obtain: Dr. Zahra Mirfeizi, Rheumatologist mirfeiziz@mums.ac.ir professor in the internal medicine group of Imam Reza Hospital, Mashhad How to obtain: The applicant can send his/her request to Dr. Zahra Mirfeiziz at mirfeiziz@mums.ac.ir by email. Comments:
public Hossein Ghazaee
No.360, Seyed Razi 48 Ave, Mashhad
Mashhad Iran (Islamic Republic of) 9188743664 +98 51 3604 2913 hosseyn.ghazaee@gmail.com Mashhad University of Medical Sciences scientific Zahra Mirfeizi
Imam Reza hospital, Imam Reza square, Rheumatology ward
Mashhad Iran (Islamic Republic of) 99199-91766 +98 51 3801 2753 mirfeiziz@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) 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. 20 years 65 years Both 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 M34 Systemic sclerosis [scleroderma] Placebo Treatment - Drugs 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 shape, color, and size, and patients consume one capsule of the placebo daily for two months. Intervention group: The probiotic capsule (LactoCare) and placebo are prepared by the Tehran Biotechnology Company. Each LactoCare capsule contains 21 milligrams of Fructooligosaccharides (FOS). Patients receive one capsule daily for 2 months. This capsule contains 10^9^ CFU of Lactobacillus ruteri, Lactobacillus rhamnosus, and Bifidobacterium bacteria. 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 2.0 Questionnaire. Emotional well-being. 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. Constipation. 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. Mashhad University of Medical Sciences Approved 2023-09-18 Ethics committee of Mashhad University of Medical Sciences Central building of Mashhad university of medical science, next to Alton tower, Daneshgah street, Mashhad, Khorasan Razavi, Iran Mashhad Razavi Khorasan Iran (Islamic Republic of)