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IRCT20250117064406N2 IRCT 2025-12-19 Semnan University of Medical Sciences Effect of synbiotic on severity uremic pruritus and muscle cramps in patients undergoing hemodialysis Effect of synbiotic on severity uremic pruritus and muscle cramps in patients undergoing hemodialysis 2026-01-30 anticipated 30 Recruiting https://irct.ir/trial/87914 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: The research sample was assigned to the study groups by permuted groups. After randomly selecting one of the two possible blocks, two consecutive samples are randomly placed in the intervention or control group. Blocking is used within gender and age. Regarding age, the first patient is randomly placed in the intervention or control group, and the next patient with a maximum age difference of five years is placed in another group. If the next patient's age difference is more than five years, the patient is randomly placed in another age block. Regarding gender, randomization is done separately for men and women. In other words, the first female patient is randomly placed in the intervention or control group and the next female patient is placed in another group, for the male patient's division is done in the same way, Blinding description: The blinding of the drug is provided to the patient by the head nurse. In this way, the patient, the researcher, and the data analyst in the study did not know about the intervention type and did not know who was in which group. N/A Hemodialysis. Intervention 1: Intervention group: The intervention group will consume two synbiotic capsules with the brand name Lactocare (500 mg) daily, one after lunch and the other after dinner, for eight weeks. Intervention 2: Control group: The control group will consume two placebo capsules (containing 500 mg of cornstarch) daily, one after lunch and one after dinner, for eight weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is The data is confidential.
public Shahein Momenabadi
Semnan University of Medical Sciences, Basij Boulevard, Semnan,
Semnan Iran (Islamic Republic of) 3513138111 +98 23 3344 1022 shahein_momenabadi@yahoo.com Semnan University of Medical Sciences scientific Shahein Momenabadi
Semnan University of Medical Sciences, Basij Boulevard, Semnan
Semnan Iran (Islamic Republic of) 3513138111 +98 23 3344 1022 shahein_momenabadi@yahoo.com Semnan University of Medical Sciences Iran (Islamic Republic of) Consent and interest in participating in the study Age 18 - 65 years old Hemodialysis treatment at least twice a week for a maximum of four hours each time Undergoing hemodialysis treatment for at least six months Presence of uremic pruritus as diagnosed by a doctor for at least six months and obtaining a score of at least mild on the YOSIPOVITCH questionnaire Experiencing muscle cramps at least once a week Life expectancy and survival for at least three months 18 years 65 years Both Kidney and organ transplant candidates Consuming synbiotics, probiotics, prebiotics, or antibiotics four weeks before participating in the study Having a severe infection within four weeks before study participation Chronic liver disease (hepatitis B, hepatitis C), pulmonary, cardiovascular, acute pancreatitis, gastrointestinal disorders (inflammatory bowel disease, ulcerative colitis, Crohn's, celiac disease, lactose intolerance or allergy, irritable bowel syndrome), active cancers, immunodeficiency, HIV N18 Chronic kidney disease (CKD) Treatment - Other Placebo Intervention group: The intervention group will consume two synbiotic capsules with the brand name Lactocare (500 mg) daily, one after lunch and the other after dinner, for eight weeks. Control group: The control group will consume two placebo capsules (containing 500 mg of cornstarch) daily, one after lunch and one after dinner, for eight weeks. Uremic pruritus severity. Timepoint: The severity of uremic pruritus will be measured before and after the intervention. Method of measurement: YOSIPOVITCH Itch Questionnaire. Muscle cramps. Timepoint: Muscle cramps will be measured before and after the intervention. Method of measurement: Visual analog scale. Semnan University of Medical Sciences Approved 2025-10-20 Ethics Committee of Semnan University of Medical Sciences Semnan University of Medical Sciences, Basij Boulevard, Semnan Semnan Semnan Iran (Islamic Republic of)