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

N

National Nutrition and Food Technology Institute

Status and phase

Completed
Phase 3
Phase 2

Conditions

Non Alcoholic Steatohepatitis

Treatments

Other: placebo
Dietary Supplement: synbiotic

Study type

Interventional

Funder types

Other

Identifiers

NCT01791959
046466

Details and patient eligibility

About

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.

Enrollment

54 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

54 participants in 2 patient groups, including a placebo group

Synbiotic
Active Comparator group
Description:
2 synbiotic capsules for 28 weeks
Treatment:
Dietary Supplement: synbiotic
maltodexterin
Placebo Comparator group
Description:
two capsules per day for 28 weeks
Treatment:
Other: placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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