The Effects of Synbiotics Supplement on Biochemical Factors and Hepatic Fibrosis in Patients With Nonalcoholic Steatohepatitis

The Effects of Synbiotics Supplement on Lipid Profile, Liver Enzymes, Inflammatory Factors and Hepatic Fibrosis in Patients With Nonalcoholic Steatohepatitis

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01791959

Enrollment

Registered

2013-02-15

Start date

2012-03-31

Completion date

2013-01-31

Last updated

2013-02-15

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

Conditions

Non Alcoholic Steatohepatitis

Brief summary

To study the effects of synbiotics supplement on lipid profile, liver enzymes, inflammatory factors and hepatic fibrosis in patients with Nonalcoholic Steatohepatitis (NASH), 50 patients who referred to Gastrointestinal (GI) clinic with steatosis grade 1 or more will be randomly allocated to receive 2 protexin capsules or placebos for 7 months; both groups will be advised to adherence our diet and exercise program too. At the first and the end of the intervention, lipid profiles, liver enzymes, some inflammatory cytokines, and liver fibrosis will be assessed and compared between groups.

Interventions

DIETARY_SUPPLEMENTsynbiotic

2 symbiotics capsules per day for 28 weeks

OTHERplacebo

2 Maltodexterin capsules as a placebo per day for 28 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Age of 18 to 70 years * Body Mass Index (BMI) between 25-40 * Serum alaninaminotransferase more than 1.5 fold of upper limit of normal range * Sonographic findings compatible with hepatic steatosis (degree 2 or more)

Exclusion criteria

* Diabetes * Taking any kind of antibiotics two weeks before recruitment * History of alcohol consumption * pregnancy or lactation * Professional athletes * Other liver disease (viral/etc) * Use of drugs such as calcium channel blockers, high dose synthetic estrogens, methotrexate , amiodarone, steroids, chloroquine, immunosuppressive drugs, lipid-lowering agents, metformin and vitamin E * A history of Hypertension, Cardiovascular disease, Pulmonary disease, Renal disease & Celiac disease; Cirrhosis * History of Upper GI surgery / Prior surgical procedures such as jejunoileal or jejunocolic bypass, gastroplasty * Following program to lose weight in recent 3 mo * A history of hypothyroidism or Cushing's syndrome

Design outcomes

Primary

Measure	Time frame
Alaninaminotransferase (ALT)	28 weeks
Liver fibrosis	28 weeks

Secondary

Measure	Time frame
Body Mass Index (BMI)	28 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026