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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20100206003290N2

Enrollment

Registered

2026-01-07

Start date

2026-01-09

Completion date

Unknown

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

liver cirrhosis. Other and unspecified cirrhosis of liver

Interventions

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 cap

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Seyed Jalil Masoumi

Shiraz University of Medical Sciences

sjm@sums.ac.ir+98 71 3725 1001

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 7, 2026