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Evaluation of Intestinal Microbiome in Obese Kids
This study is currently recruiting participants.
Verified by Medical College of Wisconsin, May 2009
First Received: December 30, 2008   Last Updated: May 20, 2009   History of Changes
Sponsored by: Medical College of Wisconsin
Information provided by: Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT00816296
  Purpose

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.


Condition Intervention
Obesity
Non-Alcoholic Fatty Liver Disease
 Other: Blood Draw
Other: Stool collection
Other: BodPod Measurement
Other: Liver Ultrasound

Study Type: Observational
Study Design: Case Control, Prospective
Official Title: Evaluation of the Intestinal Microbiome in Obese Children With and Without Non-Alcoholic Fatty Liver Disease

Resource links provided by NLM:

MedlinePlus related topics: Bowel Movement Liver Diseases Obesity Obesity in Children Ultrasound
U.S. FDA Resources

Further study details as provided by Medical College of Wisconsin:

Primary Outcome Measures:
  • Alterations in the intestinal microbiome are associated with increased immune activation and progression of obesity associated NAFLD. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Characterize the intestinal microbiome through quantitative analysis of stool samples in participants with obesity and those with obesity and NAFLD. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Characterize inflammatory markers of participants with obesity versus those obese participants that also have NAFLD. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

Participants will need to give a blood and stool samples on 3 separate occasions.


Estimated Enrollment: 400
Study Start Date: October 2008
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   5 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Gastroenterology Clinic at Children's Hospital of Wisconsin

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00816296

Locations
United States, Wisconsin
Children's Hospital of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Vinvent Biank, MD     414-266-3690     vbiank@mcw.edu    
Principal Investigator: Vincent Biank, MD            
Sponsors and Collaborators
Medical College of Wisconsin
Investigators
Principal Investigator: Vincent Biank, MD Children's Hospital and Health System Foundation, Wisconsin
  More Information

Publications:
Angulo P, Keach JC, Batts KP, Lindor KD. Independent predictors of liver fibrosis in patients with nonalcoholic steatohepatitis. Hepatology. 1999 Dec;30(6):1356-62.
Iacobellis A, Marcellini M, Andriulli A, Perri F, Leandro G, Devito R, Nobili V. Non invasive evaluation of liver fibrosis in paediatric patients with nonalcoholic steatohepatitis. World J Gastroenterol. 2006 Dec 28;12(48):7821-5.
Turnbaugh PJ, Ley RE, Mahowald MA, Magrini V, Mardis ER, Gordon JI. An obesity-associated gut microbiome with increased capacity for energy harvest. Nature. 2006 Dec 21;444(7122):1027-31.
Li Z, Soloski MJ, Diehl AM. Dietary factors alter hepatic innate immune system in mice with nonalcoholic fatty liver disease. Hepatology. 2005 Oct;42(4):880-5.
Brun P, Castagliuolo I, Di Leo V, Buda A, Pinzani M, Palù G, Martines D. Increased intestinal permeability in obese mice: new evidence in the pathogenesis of nonalcoholic steatohepatitis. Am J Physiol Gastrointest Liver Physiol. 2007 Feb;292(2):G518-25. Epub 2006 Oct 5.
Fields DA, Goran MI, McCrory MA. Body-composition assessment via air-displacement plethysmography in adults and children: a review. Am J Clin Nutr. 2002 Mar;75(3):453-67. Review.
Nicholson JC, McDuffie JR, Bonat SH, Russell DL, Boyce KA, McCann S, Michael M, Sebring NG, Reynolds JC, Yanovski JA. Estimation of body fatness by air displacement plethysmography in African American and white children. Pediatr Res. 2001 Oct;50(4):467-73.

Responsible Party: Medical College of Wisconsin ( Vincent Biank )
Study ID Numbers: CHW 08/159, GC 727
Study First Received: December 30, 2008
Last Updated: May 20, 2009
ClinicalTrials.gov Identifier: NCT00816296     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Medical College of Wisconsin:
NAFLD
Obesity
Microbiome

Study placed in the following topic categories:
Body Weight
Signs and Symptoms
Obesity
Liver Diseases
Non-alcoholic Steatohepatitis (NASH)
 Digestive System Diseases
Nutrition Disorders
Overweight
Overnutrition
Fatty Liver

Additional relevant MeSH terms:
Body Weight
Signs and Symptoms
Obesity
Liver Diseases
Digestive System Diseases
 Nutrition Disorders
Overweight
Overnutrition
Fatty Liver

ClinicalTrials.gov processed this record on September 02, 2009



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