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IRCT20100206003290N2 IRCT 2026-01-07 Shiraz University of Medical Sciences Investigation of the Effect of Concurrent Administration of Synbiotic Supplement and Vitamin D Supplement in Liver Cirrhosis Investigation of the Effect of Concurrent Administration of Synbiotic Supplement and Vitamin D Supplement on Liver Disease Severity, Minimal Hepatic Encephalopathy, Quality of Life, Sleep, Mental Health, and Appetite in Patients with Liver Cirrhosis: A Double-Blind Randomized Clinical Trial 2026-01-09 anticipated 66 Recruiting https://irct.ir/trial/87556 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Randomization was performed using block randomization with permuted blocks and variable block sizes of 4 and 6 and an allocation ratio of 1:1. The randomization sequence was generated using the website www.sealedenvelope.com . Considering approximately 10% dropout, the final sample size was determined as 66 participants, and they were allocated to the intervention and control groups based on this sequence, Blinding description: Allocation Concealment Mechanism: To ensure blinding of all researchers and participants, a third individual who is not involved in conducting the study will prepare the random allocation list for assigning participants to the groups. This person will label all intervention containers—identical in appearance and color—based on coded numbering. Therefore, participants will remain unaware of the type of intervention they receive, and the random sequence will be unpredictable. Double-Blind Design: The study will be conducted in a double-blind manner: both the participants and the researcher will be unaware of the type of intervention administered. All supplements and placebos will be identical in shape, color, size, and packaging. 3 liver cirrhosis. Intervention 1: Intervention Group (A):Patients receive synbiotic and vitamin D for 8 weeks.Synbiotic: FamiLact 2 Plus (Zist Takhmir), 1 capsule daily after lunch. Vitamin D 50,000 IU (Zahravi), 1 capsule weekly. Intervention 2: Control group (B): Patients will receive synbiotic placebo and vitamin D placebo for 8 weeks. FamiLact 2 Plus synbiotic placebo (starch) produced by Shiraz Faculty of Pharmacy: 1 capsule daily after lunch. Vitamin D placebo (paraffin) produced by Zahravi Pharmaceutical Company: 1 capsule weekly. No - There is not a plan to make this available Justification or reason for not sharing IPD is Due to the confidential and sensitive nature of participants’ information, and in order to comply with research ethics and protect patient privacy, there is no plan to share individual participant data (IPD). All data will be used solely within the study protocol and under the supervision of the Ethics Committee.
public Dr. Seyed Jalil Masoumi
School of Nutrition and Food Sciences, opposite Bargh Sports Club, Razi Boulevard, Shiraz
Shiraz Iran (Islamic Republic of) 7153675500 +98 71 3725 1001 sjm@sums.ac.ir Shiraz University of Medical Sciences scientific Dr. Seyed Jalil Masoumi
School of Nutrition and Food Sciences, opposite Bargh Sports Club, Razi Boulevard, Shiraz
Shiraz Iran (Islamic Republic of) 7153675541 +98 71 3725 1001 sjm@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Patients with liver cirrhosis, with a definite diagnosis of cirrhosis made by a gastroenterologist based on at least one of the following methods: Fibroscan (F4), liver biopsy, imaging (ultrasound, CT, MRI), or confirmation by a gastroenterology subspecialist. Patients with vitamin D deficiency (less than 30 nanograms per milliliter) Having at least a high-school diploma Willingness to participate in the study 18 years no limit Both History of alcohol consumption in the past 6 months Patients with severe complications or medical conditions that may affect the course of the study. Patients with a history of psychiatric disorders or the use of specific medications that may interfere with therapeutic effects. Receiving synbiotic as a supplement during the past 2–3 months Receiving vitamin D supplement orally during the past 2–3 months Receiving antibiotics in the past 2 weeks Pregnancy, breastfeeding K74.6 Other and unspecified cirrhosis of liver Treatment - Drugs Placebo Intervention Group (A):Patients receive synbiotic and vitamin D for 8 weeks.Synbiotic: FamiLact 2 Plus (Zist Takhmir), 1 capsule daily after lunch. Vitamin D 50,000 IU (Zahravi), 1 capsule weekly. Control group (B): Patients will receive synbiotic placebo and vitamin D placebo for 8 weeks. FamiLact 2 Plus synbiotic placebo (starch) produced by Shiraz Faculty of Pharmacy: 1 capsule daily after lunch. Vitamin D placebo (paraffin) produced by Zahravi Pharmaceutical Company: 1 capsule weekly. Minimal hepatic encephalopathy. Timepoint: Measurement of minimal hepatic encephalopathy at baseline before the intervention and again two months after the intervention. Method of measurement: Psychometric Hepatic Encephalopathy Score. Severity liver disease. Timepoint: All outcomes will be measured at baseline before the intervention and again two months after the intervention. Method of measurement: Using the calculation of the MELD index, which is a model for end-stage liver disease, it is calculated by means of three indicators, bilirubin, creatinine, and the international normalized ratio, using the formula: 0.957 × natural logarithm of creatinine + 0.378 × natural logarithm of bilirubin + 1.120 × natural logarithm of INR + 6.43. Mental health score. Timepoint: All outcomes will be measured at baseline before the intervention and again two months after the intervention. Method of measurement: Beck Depression Inventory-II. Score of Appetite. Timepoint: All outcomes will be measured at baseline before the intervention and again two months after the intervention. Method of measurement: Simplified Nutritional Appetite Questionnaire. Sleep quality score. Timepoint: All outcomes will be measured at baseline before the intervention and again two months after the intervention. Method of measurement: Pittsburgh Sleep Quality Index. Quality of life score. Timepoint: All outcomes will be measured at baseline before the intervention and again two months after the intervention. Method of measurement: Short-form-12-health-survey-questionnaire. Physical Activity score. Timepoint: All outcomes will be measured at baseline before the intervention and again two months after the intervention. Method of measurement: Short Form International Physical Activity Questionnaire (SF-IPAQ). Food intake. Timepoint: All outcomes will be measured at baseline before the intervention and again two months after the intervention. Method of measurement: Three-day dietary recall. Weight. Timepoint: All outcomes will be measured at baseline before the intervention and again two months after the intervention. Method of measurement: Digital scale. Waist Circumference. Timepoint: All outcomes will be measured at baseline before the intervention and again two months after the intervention. Method of measurement: It is measured around the abdomen using a flexible measuring tape. Height. Timepoint: All outcomes will be measured at baseline before the intervention and again two months after the intervention. Method of measurement: Participants’ height is measured using a calibrated wall-mounted stadiometer, barefoot and in a standing position; the head is positioned with a direct forward gaze and the chin in a natural position (not up and not down). Height is recorded to the nearest 0.1 cm. The measurement is performed twice and the mean is used. Body mass index (BMI). Timepoint: All outcomes will be measured at baseline before the intervention and again two months after the intervention. Method of measurement: Body mass index (BMI) is calculated as weight (kg) divided by height (m) squared. Shiraz University of Medical Sciences Approved 2025-10-12 Ethics Committee of Schools of Public Health, Nutrition & Food Sciences of Shiraz Medical University School of Nutrition and Food Sciences, opposite Bargh Sports Club, Razi Blvd, Shiraz Shiraz Fars Iran (Islamic Republic of)