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ObesityNCT00816296

Evaluation of Intestinal Microbiome in Obese Kids

An observational study of Obesity and Non-Alcoholic Fatty Liver Disease, run by Medical College of Wisconsin at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 5 to 18 years
Conditions the study is for
Obesity, Non-Alcoholic Fatty Liver Disease
What is being tested?
Blood Draw, Stool collection and BodPod Measurement
How many people
0 participants
Where
1 siteUnited States
Study dates
Oct 2008to Oct 2012
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Study population: Gastroenterology Clinic at Children's Hospital of Wisconsin

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Children's Hospital of Wisconsin

    Milwaukee, Wisconsin, 53226

Other trials in United States

About this study

Official title: 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.

Read the 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.
Being tested
Blood Draw, Stool collection, BodPod Measurement, Liver Ultrasound
Keywords
NAFLD, Obesity, Microbiome
Medical subject headings
Obesity, Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood DrawOther

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

  • Stool collectionOther

    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.

  • BodPod MeasurementOther

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

  • Liver UltrasoundOther

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

Study groups in NCT00816296
Study groupRoleWhat they receive
ControlsObese (BMI>30) and normal AST and ALT. Between the ages of 5 and 18 years old.
Receives: Other: Blood Draw; Other: Stool collection; Other: BodPod Measurement; Other: Liver Ultrasound
Liver DiseaseObese (BMI>30) and elevated AST and/or ALT (evidence of NAFLD). Between the ages of 5 and 18 years old.
Receives: Other: Blood Draw; Other: Stool collection; Other: BodPod Measurement; Other: Liver Ultrasound

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 3 years

Secondary outcomes (2)

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

    Measured: 3 years

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

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jan 2009 (estimated)
  2. Study startOct 2008
  3. Primary completionOct 2011 (estimated)
  4. Study completionOct 2012 (estimated)

Why it stopped: PI has left institution

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00816296
Sponsor's protocol ID
CHW 08/159
Other IDs
GC 727
Status last verified
Aug 2015
First submitted
30 Dec 2008
Last updated
24 Aug 2015
Results posted
No
Data monitoring committee
No

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. doi: 10.1002/hep.510300604.

    PubMed 10573511

  • 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.

    PubMed 17203527

  • 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.

    PubMed 17183312

  • 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.

    PubMed 16175608

  • 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.

    PubMed 17023554

  • 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.

    PubMed 11864850

  • 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.

    PubMed 11568289

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity and Non-Alcoholic Fatty Liver Disease, run by Medical College of Wisconsin at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 24 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Alterations in the intestinal microbiome are associated with increased immune activation and progression of obesity associated NAFLD. (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00816296, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2015.

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