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CompletedNCT01791959Updated Feb 15, 2013

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

A Phase 2/3 interventional study of synbiotic and placebo in Non Alcoholic Steatohepatitis, sponsored by National Nutrition and Food Technology Institute. Completed. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2013-02-15.

Sponsored by National Nutrition and Food Technology Institute · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

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Conditions studied

  • Non Alcoholic Steatohepatitis
03

In context

Fatty Liver

1,451 studies on the registry are indexed under Fatty Liver; 292 are open to participants now.

This study's enrollment of 54 is close to the median of 60 across 1,003 interventional studies indexed under Fatty Liver.

Browse Fatty Liver studies →

Lead sponsor

National Nutrition and Food Technology Institute is the lead sponsor of 62 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
54 participants (actual)

Study arms

  • Active comparator
    Synbiotic

    2 synbiotic capsules for 28 weeks

    Dietary Supplement: synbiotic

  • Placebo comparator
    maltodexterin

    two capsules per day for 28 weeks

    Other: placebo

Interventions

  • Dietary supplementsynbiotic

    2 symbiotics capsules per day for 28 weeks

  • Otherplacebo

    2 Maltodexterin capsules as a placebo per day for 28 weeks

06

What researchers measure

Primary outcomes

  1. Alaninaminotransferase (ALT)

    Time frame: 28 weeks

  2. Liver fibrosis

    Time frame: 28 weeks

Secondary outcomes

  1. Body Mass Index (BMI)

    Time frame: 28 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 24401715 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 15, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01791959
Lead sponsor
National Nutrition and Food Technology Institute
Responsible party
Dr Azita Hekmatdoost (Principal Investigator, National Nutrition and Food Technology Institute) — Principal investigator
First posted
Feb 15, 2013
Start date
Mar 2012
Primary completion
Oct 2012
Completion
Jan 2013
Last update
Feb 15, 2013

Study contacts

Azita Hekmatdoost, MD, PhD
principal investigator · National Nutrition and Food Technology Research Institute

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.

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