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Effects of probiotic on nonalcolic steatohepatitis

Effects of probiotic and metformin on nonalcolic steatohepatitis: a double blind randomized clinical trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT201204049376N1
Enrollment
63
Registered
2012-07-05
Start date
2010-11-21
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Nonalcoholic steatohepatitis. Inflammatory liver disease, unspecified Hepatitis NOS

Interventions

Intervention 1: Control group: treated with Metformin 500 mg two tablets per day plus two placebo tablet two tablets per day for six month. Intervention 2: Protexin two tablets per day plus Metformin
Behavior
Treatment - Drugs
Control group: treated with Metformin 500 mg two tablets per day plus two placebo tablet two tablets per day for six month
Protexin two tablets per day plus Metformin 500 mg two tablets per day for six month

Sponsors

Isfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: patients admitted to Al Zahra hospital over 18 years, who have NASH confirmed by biopsy. Exclusion criteria: any participant who will take antibiotics for any indication for more than 1 week during the study period or before recruitment to the study; loosing more than 10% of baseline body weight during the study period; autoimmune hepatitis; Wilson's disease; HBV/HCV/HIV/EBV/CMV infection; pregnancy and lactation

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Alanine transaminase (ALT). Timepoint: Before and after treatment. Method of measurement: Blood test.;Aspartate aminotransferse (AST). Timepoint: before and after treatment. Method of measurement: blood test AST.;Ultrasound Grade of NASH. Timepoint: before and after treatment. Method of measurement: ultrasound.

Secondary

MeasureTime frame
Fasting blood suger (FBS). Timepoint: before and after treatment. Method of measurement: blood test.;Chlosterol. Timepoint: befoer and after treatment. Method of measurement: blood test.;Triglyceride. Timepoint: before and after treatment. Method of measurement: blood test.;Body mass index (BMI). Timepoint: before and after treatment. Method of measurement: measure weight and height.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHassan Firouzian

Isfahan University of Medical Sciences

hassan_firoozian@resident.mui.ac.ir & firoozian_hassan@yahoo.com+98 31 1628 9000

Outcome results

None listed

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