The effect of probiotics consumption on liver function

The effect of probiotics consumption on liver function in Primary Sclerosing Cholangitis patients: A double-blinded randomized clinical trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200628047940N3

Enrollment

Registered

2022-07-18

Start date

2022-08-23

Completion date

Unknown

Last updated

2022-08-29

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

Conditions

Primary Sclerosing Cholangitis. Cholangitis

Interventions

Intervention 1: Intervention group: probiotic containing Lactobacillus rhamnosus, Bifidobacterium lactis, Lactobacillus casei Bifidobacterium bruh, Lactobacillus acidophilus, Bifidobacterium longum,

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Patients with a definitive diagnosis of primary sclerosing cholangitis(PSC) Patients' informed consent to participate in the study

Exclusion criteria

Exclusion criteria: Neurological disease Chronic alcoholic fatty liver Chronic hepatitis B, C Wilson disease Hemochromatosis disease Secondary sclerosing cholangitis Primary cirrhosis of the bile ducts Benign or malignant tumor of the liver or bile ducts Peritonitis Ascites Variceal bleeding Inflammation of the brain caused by hepatitis in the past 2 months Consumption of probiotics, prebiotics, synbiotics or antibiotics 4 weeks before the start of the study High protein diet Active microbial infection Autoimmune disease or the use of immunosuppressive drugs Probability of liver transplantation in the next year based on secondary sclerosing cholangitis risk score Mayo Alpha antitrypsin deficiency Consumption of ursodeoxycholic acid Consumption of alcohol or drugs Pregnancy and lactation

Design outcomes

Primary

Measure	Time frame
Alkaline phosphatase changes. Timepoint: Before the start of study and one month after the end of taking probiotics and placebo. Method of measurement: Alkaline phosphatase test.	—

Secondary

Measure	Time frame
Total bilirubin changes. Timepoint: Before the start of the study and one month after the end of taking probiotics and placebo. Method of measurement: Total bilirubin test.;Primary sclerosing cholangitis risk score changes, based on Mayo clinic. Timepoint: Before the start of the study and one month after the end of taking probiotics and placebo. Method of measurement: Primary sclerosing cholangitis risk score changes, based on Mayo clinic: A decision-making model for primary sclerosing cholangitis based on five variables: 1-Age in years 2-Total bilirubin in mg/dL 3-Serum albumin in g/dL 4-AST in IU/L 5-Variceal bleeding.	—

Measure

Time frame

Total bilirubin changes. Timepoint: Before the start of the study and one month after the end of taking probiotics and placebo. Method of measurement: Total bilirubin test.;Primary sclerosing cholangitis risk score changes, based on Mayo clinic. Timepoint: Before the start of the study and one month after the end of taking probiotics and placebo. Method of measurement: Primary sclerosing cholangitis risk score changes, based on Mayo clinic: A decision-making model for primary sclerosing cholangitis based on five variables: 1-Age in years 2-Total bilirubin in mg/dL 3-Serum albumin in g/dL 4-AST in IU/L 5-Variceal bleeding.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactFardad Ejtehadi

Shiraz University of Medical Sciences

edjtehadif@sums.ac.ir+98 21 3647 4316

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026