Evaluation of Intestinal Microbiome in Obese Kids

NCT00816296 | Withdrawn

• 2 other identifiers: CHW 08/159GC 727
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity; Non-Alcoholic Fatty Liver Disease

Keywords

NAFLD; Obesity; Microbiome

Outcome Measures

Primary Outcomes (1)

• Alterations in the intestinal microbiome are associated with increased immune activation and progression of obesity associated NAFLD.

  3 years

Secondary Outcomes (2)

• Characterize the intestinal microbiome through quantitative analysis of stool samples in participants with obesity and those with obesity and NAFLD.

  3 years

• Characterize inflammatory markers of participants with obesity versus those obese participants that also have NAFLD.

  3 years

Study Arms (2)

Controls

Obese (BMI\>30) and normal AST and ALT. Between the ages of 5 and 18 years old.

Other: Blood Draw; Other: Stool collection; Other: BodPod Measurement; Other: Liver Ultrasound

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; Other: Stool collection; Other: BodPod Measurement; Other: Liver Ultrasound

Interventions

Blood Draw OTHER

2 tablespoons of blood will be drawn from participants at study entry, 3 months after study entry, and 6 months after study entry.

Controls; Liver Disease

Stool collection OTHER

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.

Controls; Liver Disease

BodPod Measurement OTHER

Body composition will be measured using a BodPod at study entry, 3 months after study entry, and 6 months after study entry.

Controls; Liver Disease

Liver Ultrasound OTHER

A liver ultrasound will be performed at study entry and 6 months after study entry.

Controls; Liver Disease

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Gastroenterology Clinic at Children's Hospital of Wisconsin

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (7)

• 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. doi: 10.1002/hep.510300604.

  PMID: 10573511 BACKGROUND

• 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. doi: 10.3748/wjg.v12.i48.7821.

  PMID: 17203527 BACKGROUND

• 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. doi: 10.1038/nature05414.

  PMID: 17183312 BACKGROUND

• 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. doi: 10.1002/hep.20826.

  PMID: 16175608 BACKGROUND

• Brun P, Castagliuolo I, Di Leo V, Buda A, Pinzani M, Palu 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. doi: 10.1152/ajpgi.00024.2006. Epub 2006 Oct 5.

  PMID: 17023554 BACKGROUND

• 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. doi: 10.1093/ajcn/75.3.453.

  PMID: 11864850 BACKGROUND

• 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. doi: 10.1203/00006450-200110000-00008.

  PMID: 11568289 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Obesity; Non-alcoholic Fatty Liver Disease

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Vincent Biank, MD

  Children's Hospital and Health System Foundation, Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 30, 2008
• First Posted: January 1, 2009
• Study Start: October 1, 2008
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2012
• Last Updated: August 24, 2015

Record last verified: 2015-08

Locations

US (1)