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
About this trial
This is an interventional treatment trial for Non Alcoholic Steatohepatitis
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
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
NCT ID
NCT01791959
First Posted
February 5, 2013
Last Updated
February 12, 2013
Sponsor
National Nutrition and Food Technology Institute
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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