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

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ClinicalTrials.gov Identifier: NCT01791959
Recruitment Status : Completed
First Posted : February 15, 2013
Last Update Posted : February 15, 2013
Sponsor:
Information provided by (Responsible Party):
Dr Azita Hekmatdoost, National Nutrition and Food Technology Institute

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.

Condition or disease Intervention/treatment Phase
Non Alcoholic Steatohepatitis Dietary Supplement: synbiotic Other: placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Synbiotics Supplement on Lipid Profile, Liver Enzymes, Inflammatory Factors and Hepatic Fibrosis in Patients With Nonalcoholic Steatohepatitis
Study Start Date : March 2012
Actual Primary Completion Date : October 2012
Actual Study Completion Date : January 2013


Arm Intervention/treatment
Active Comparator: Synbiotic
2 synbiotic capsules for 28 weeks
Dietary Supplement: synbiotic
2 symbiotics capsules per day for 28 weeks

Placebo Comparator: maltodexterin
two capsules per day for 28 weeks
Other: placebo
2 Maltodexterin capsules as a placebo per day for 28 weeks




Primary Outcome Measures :
  1. Alaninaminotransferase (ALT) [ Time Frame: 28 weeks ]
  2. Liver fibrosis [ Time Frame: 28 weeks ]

Secondary Outcome Measures :
  1. Body Mass Index (BMI) [ Time Frame: 28 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01791959


Sponsors and Collaborators
National Nutrition and Food Technology Institute
Investigators
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Principal Investigator: Azita Hekmatdoost, MD, PhD National Nutrition and Food Technology Research Institute
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr Azita Hekmatdoost, Principal Investigator, National Nutrition and Food Technology Institute
ClinicalTrials.gov Identifier: NCT01791959    
Other Study ID Numbers: 046466
First Posted: February 15, 2013    Key Record Dates
Last Update Posted: February 15, 2013
Last Verified: February 2013
Additional relevant MeSH terms:
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Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases