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

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

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.

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

• 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

Contacts and Locations

Sponsors and Collaborators

National Nutrition and Food Technology Institute

Investigators

• Principal Investigator: Azita Hekmatdoost, MD, PhD; National Nutrition and Food Technology Research Institute

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• 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
• Last Update Posted: February 15, 2013
• Last Verified: February 2013

Additional relevant MeSH terms:

Fatty Liver; Non-alcoholic Fatty Liver Disease; Liver Diseases; Digestive System Diseases