The assessment of probiotics' effects on gastrointestinal inflammation and symptoms in patients with scleroderma

Probiotics' effects on gastrointestinal inflammation and symptoms in patients with Scleroderma

A randomized, double-blind, parallel-group, phase 3 clinical trial was conducted on 44 patients with a control group. The randomization was performed using the rand function in Microsoft Excel software.

After the diagnosis of scleroderma by a rheumatologist, patients were randomly divided into two equal groups using block randomization. One group was prescribed a probiotic daily; the other group was prescribed a placebo. Patients who completed the entry and exit conditions of the study were placed under standard scleroderma treatment. The study was conducted at the Rheumatology Clinic of Imam Reza Hospital in Mashhad. Blinding was performed for the physician, patient, and evaluator.

Inclusion: 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: Pregnancy Breastfeeding Active infection New organ involvement IBS Malignancy IBD and ulcerative colitis Antibiotic intake in the past 2 weeks Probiotic, endoxan, rituximab, and biologic drugs intake in the past 4 weeks Medication changes in 2 month period of follow-up Overlap syndromes Voluntary withdrawal from the study

In the intervention group, patients with scleroderma receive a probiotic tablet daily for 2 months. In the control group, patients receive a placebo drug.

IL-17, IL-4, IFN-δ, and IL-10 gastrointestinal symptoms, including reflux, bloating, fecal soiling, diarrhea, emotional and social function, and constipation, using the GIT 2.0 Score questionnaire.

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.

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

Information related to the main purpose of the study and data related to it is available for sharing

Starting accessibility 6 months after publication

Researchers from universities and scientific institutions and people who are engaged in industry

The data could be used in clinical and research intentions

Dr. Zahra Mirfeizi, Rheumatologist mirfeiziz@mums.ac.ir professor in the internal medicine group of Imam Reza Hospital, Mashhad

The applicant can send his/her request to Dr. Zahra Mirfeiziz at mirfeiziz@mums.ac.ir by email.