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

Primary Purpose

Non Alcoholic Steatohepatitis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
synbiotic
placebo
Sponsored by
National Nutrition and Food Technology Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Alcoholic Steatohepatitis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Synbiotic

    maltodexterin

    Arm Description

    2 synbiotic capsules for 28 weeks

    two capsules per day for 28 weeks

    Outcomes

    Primary Outcome Measures

    Alaninaminotransferase (ALT)
    Liver fibrosis

    Secondary Outcome Measures

    Body Mass Index (BMI)

    Full Information

    First Posted
    February 5, 2013
    Last Updated
    February 12, 2013
    Sponsor
    National Nutrition and Food Technology Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01791959
    Brief Title
    The Effects of Synbiotics Supplement on Biochemical Factors and Hepatic Fibrosis in Patients With Nonalcoholic Steatohepatitis
    Official Title
    The Effects of Synbiotics Supplement on Lipid Profile, Liver Enzymes, Inflammatory Factors and Hepatic Fibrosis in Patients With Nonalcoholic Steatohepatitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2012 (undefined)
    Primary Completion Date
    October 2012 (Actual)
    Study Completion Date
    January 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    National Nutrition and Food Technology Institute

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Non Alcoholic Steatohepatitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    54 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Synbiotic
    Arm Type
    Active Comparator
    Arm Description
    2 synbiotic capsules for 28 weeks
    Arm Title
    maltodexterin
    Arm Type
    Placebo Comparator
    Arm Description
    two capsules per day for 28 weeks
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    synbiotic
    Intervention Description
    2 symbiotics capsules per day for 28 weeks
    Intervention Type
    Other
    Intervention Name(s)
    placebo
    Intervention Description
    2 Maltodexterin capsules as a placebo per day for 28 weeks
    Primary Outcome Measure Information:
    Title
    Alaninaminotransferase (ALT)
    Time Frame
    28 weeks
    Title
    Liver fibrosis
    Time Frame
    28 weeks
    Secondary Outcome Measure Information:
    Title
    Body Mass Index (BMI)
    Time Frame
    28 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Azita Hekmatdoost, MD, PhD
    Organizational Affiliation
    National Nutrition and Food Technology Research Institute
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    24401715
    Citation
    Eslamparast T, Poustchi H, Zamani F, Sharafkhah M, Malekzadeh R, Hekmatdoost A. Synbiotic supplementation in nonalcoholic fatty liver disease: a randomized, double-blind, placebo-controlled pilot study. Am J Clin Nutr. 2014 Mar;99(3):535-42. doi: 10.3945/ajcn.113.068890. Epub 2014 Jan 8.
    Results Reference
    derived

    Learn more about this trial

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

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