Evaluation of Intestinal Microbiome in Obese Kids

August 21, 2015 updated by: Medical College of Wisconsin

Evaluation of the Intestinal Microbiome in Obese Children With and Without Non-Alcoholic Fatty Liver Disease

The goal of this study is to investigate comparisons between the intestinal microbiome in patients with obesity and in patients with obesity and Non-Alcoholic Fatty Liver Disease (NAFLD). With this protocol we hope to better understand how the microbiome of each individual works with disease progression.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

The goal of this study is to investigate and compare the composition of the intestinal microbiome in patients with obesity only to patients with obesity and Non-Alcoholic Fatty Liver Disease (NAFLD). In addition, we will investigate the relationship between alterations in the intestinal microbiome, immune activation, and the progression of NAFLD to Non-Alcoholic Steatohepatitis (NASH). We hypothesize that alterations in the intestinal microbiome are associated with increased immune activation and progression of obesity associated NAFLD. Based on this hypothesis we propose the following aims:

Aim 1. Identify and enroll pediatric cohort with obesity or obesity/NAFLD to study the role of the intestinal microbiome on the development of NAFLD.

  1. Enroll participants through the NEW Kids program for treatment of pediatric obesity at Children's Hospital of Wisconsin (CHW). Identify and classify participants through initial clinical evaluation, collect clinical metadata, and obtain and process blood and stool samples for analysis. Demonstrate feasibility by showing that participants can be recruited and participate in the specific study protocol.
  2. Follow study population through nutritional/exercise intervention, with follow up collection of clinical data, stool, and blood samples.

Aim 2. Characterize the intestinal microbiome through quantitative PCR and high throughput sequencing analysis of stool specimens in participants with obesity and obesity/NAFLD.

  1. Demonstrate feasibility by showing that sampling aliquots from patient fecal samples can be successfully analyzed by proposed methods and yield consistent results for duplicate samples.
  2. Compare sequencing results and metagenomic analysis for study groups with particular attention to bacterial composition and metabolic capacity associated with energy harvest, lipid and carbohydrate transport, enhancement of epithelial barrier integrity, and choline metabolism.
  3. Investigate whether intervention (nutritional/exercise) results in longitudinal alterations in the intestinal microbiome.

Aim 3. Characterize evidence of systemic inflammation by C-reactive protein (CRP), Tumor necrosis factor alpha (TNF-alpha)Transforming growth factor beta 1 (TGF-beta and LPS Binding Protein (LBP) levels, and analyze results in relationship to the intestinal microbiome and the presence of NAFLD.

  1. Compare levels of systemic inflammatory markers of participants with obesity vs. obesity/NAFLD
  2. Investigate whether intervention (nutritional/exercise) results in longitudinal alterations in systemic inflammation.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Children's Hospital of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Gastroenterology Clinic at Children's Hospital of Wisconsin

Description

Inclusion Criteria:

  • Age 5-18 Years old
  • Willing to consent/undergo necessary procedures
  • Obese (BMI>30)
  • Speak English or Spanish

Exclusion Criteria:

  • any other causes of liver disease
  • any chronic illnesses or life threatening conditions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Controls
Obese (BMI>30) and normal AST and ALT. Between the ages of 5 and 18 years old.
Other: Blood Draw
2 tablespoons of blood will be drawn from participants at study entry, 3 months after study entry, and 6 months after study entry.
Other: Stool collection
Stool will be collected from participants 3 times during the study -- at study entry, 3 months from study entry, and 6 months after study entry.
Other: BodPod Measurement
Body composition will be measured using a BodPod at study entry, 3 months after study entry, and 6 months after study entry.
Other: Liver Ultrasound
A liver ultrasound will be performed at study entry and 6 months after study entry.
Liver Disease
Obese (BMI>30) and elevated AST and/or ALT (evidence of NAFLD). Between the ages of 5 and 18 years old.
Other: Blood Draw
2 tablespoons of blood will be drawn from participants at study entry, 3 months after study entry, and 6 months after study entry.
Other: Stool collection
Stool will be collected from participants 3 times during the study -- at study entry, 3 months from study entry, and 6 months after study entry.
Other: BodPod Measurement
Body composition will be measured using a BodPod at study entry, 3 months after study entry, and 6 months after study entry.
Other: Liver Ultrasound
A liver ultrasound will be performed at study entry and 6 months after study entry.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Alterations in the intestinal microbiome are associated with increased immune activation and progression of obesity associated NAFLD.
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Characterize the intestinal microbiome through quantitative analysis of stool samples in participants with obesity and those with obesity and NAFLD.
Time Frame: 3 years
3 years
Characterize inflammatory markers of participants with obesity versus those obese participants that also have NAFLD.
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical College of Wisconsin

Investigators

  • Principal Investigator: Vincent Biank, MD, Children's Hospital and Health System Foundation, Wisconsin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Anticipated)

October 1, 2011

Study Completion (Anticipated)

October 1, 2012

Study Registration Dates

First Submitted

December 30, 2008

First Submitted That Met QC Criteria

December 30, 2008

First Posted (Estimate)

January 1, 2009

Study Record Updates

Last Update Posted (Estimate)

August 24, 2015

Last Update Submitted That Met QC Criteria

August 21, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHW 08/159
  • GC 727

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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