NCT02530138

Brief Summary

Introduction: Currently, Nonalcoholic Fatty Liver Disease (NAFLD) is the most common liver disease in the world. The only approved treatment for it is lifestyle modification and weight loss; however, there is no evidence for patients with normal or low body mass index (BMI). The aim of this study is to evaluate the efficacy of symbiotic supplementation in NAFLD patients with normal or low BMI. Methods and analysis: In this randomized, double-blind, placebo-controlled clinical trial protocol, 21 cases and 21 controls will be individually matched based on age and sex. This 42 patients with NAFLD will be supplemented twice daily for 28 wk with either a synbiotic or a placebo capsule. Both groups will be advised to follow an energy balanced diet and physical activity recommendations.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

August 18, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 20, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Last Updated

August 20, 2015

Status Verified

August 1, 2015

Enrollment Period

1.5 years

First QC Date

August 18, 2015

Last Update Submit

August 19, 2015

Conditions

Non Alcoholic Steatohepatitis

Outcome Measures

Primary Outcomes (2)

  • Alaninaminotransferase (ALT) (UL)

    by biochemical method

    28 weeks

  • hepatic steatosis (cap score)

    using transient elastography

    28 weeks

Secondary Outcomes (1)

  • Body Mass Index (BMI) (kg/m2)

    28 weeks

Study Arms (2)

Synbiotic

ACTIVE COMPARATOR

2 synbiotic capsules for 28 weeks

Dietary Supplement: synbiotic

maltodexterin

PLACEBO COMPARATOR

two capsules per day for 28 weeks

Dietary Supplement: Placebo

Interventions

synbioticDIETARY_SUPPLEMENT

2 symbiotics capsules per day for 28 weeks

Synbiotic
PlaceboDIETARY_SUPPLEMENT

2 placebo capsules per day for 28 weeks

maltodexterin

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age of 18 to 70 years
  • Body Mass Index (BMI) below 25
  • Serum alaninaminotransferase more than 1.5 fold of upper limit of normal range
  • Sonographic findings compatible with hepatic steatosis (degree 2 or more)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NNFTRI clinic

Tehran, Tehran Province, 19435, Iran

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Synbiotics

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

PrebioticsDietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaProbioticsFood and Beverages

Central Study Contacts

Azita Hakmatdost, MD, PhD

CONTACT

9123065084a_hekmat2000@yahoo.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate prof

Study Record Dates

First Submitted

August 18, 2015

First Posted

August 20, 2015

Study Start

August 1, 2014

Primary Completion

February 1, 2016

Last Updated

August 20, 2015

Record last verified: 2015-08

Locations

IR(1)