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Probiotics and the Gut Microbiome in Obese Hispanic Youth

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ClinicalTrials.gov Identifier: NCT03115385
Recruitment Status : Terminated (Funds ended.)
First Posted : April 14, 2017
Last Update Posted : April 14, 2017
Sponsor:
Information provided by (Responsible Party):
Michael I. Goran, University of Southern California

Tracking Information
First Submitted Date  ICMJE March 29, 2017
First Posted Date  ICMJE April 14, 2017
Last Update Posted Date April 14, 2017
Actual Study Start Date  ICMJE May 30, 2015
Actual Primary Completion Date April 11, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2017)
Change in abundance of gut microbiome and gut hormones measured pre and post blood and stool sample collections. [ Time Frame: 16 weeks ]
To determine whether probiotic (VSL#3) supplementation affects gut microbiome and gut hormones involved with appetite regulation in obese young Hispanics.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2017)
Interaction between gut microbiome and liver fat, fibrosis, obesity, and glycemia measured pre and post blood and stool sample collections and through Dxa and MRI scans.. [ Time Frame: 16 weeks ]
To determine whether there are any relationships between changes in the gut microbiome and changes in liver fat, fibrosis, obesity, and glycemia after 16 weeks of probiotic supplementation.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Probiotics and the Gut Microbiome in Obese Hispanic Youth
Official Title  ICMJE Probiotics and the Gut Microbiome in Obese Hispanic Youth
Brief Summary This study will recruit 40 obese Hispanic youth (12 - 18 years of age who are greater than or equal to Tanner stage 4) from hospitals, clinics, and community centers. Participants will be randomly assigned to 16 weeks of probiotics (3 packets/day of VSL#3) or matched placebo. The purpose of this study is to demonstrate through a proof-of-concept trial that probiotics have the potential to alter the gut microbiome and gut hormones.
Detailed Description Recent studies suggest that probiotic supplementation has the potential to restore gut microbiota homeostasis and reduce fatty liver. No studies have examined the effects of probiotic supplementation on the gut microbiome in obese Hispanic youth who are increased risk of type 2 diabetes and fatty liver. Therefore, the investigator proposes a double-blind randomized trial of probiotic supplementation in obese Hispanic youth in order to determine if probiotic supplementation results in alterations to the gut micro biome. The purpose of this study is to demonstrate through a proof-of-concept trial that probiotics have the potential to alter the gut microbiome and gut hormones. As a secondary aim the investigator will examine wether any changes in the gut microbiome are related to changes in liver fat, fibrosis, glycemia, or body weight. The study team will recruit 40 obese Hispanic youth (12 - 18 years of age who are greater than or equal to Tanner stage 4) from hospitals, clinics, and community centers. The studies primary outcome is alterations in the composition of the gut microbiome which will be examined through fecal and blood bacterial profiling (16S DNA targeted metagenomics), markers of gut permeability/bacterial translocation, and gut derived hormones involved with appetite regulation (GLP-1, peptide YY, ghrelin). Secondary outcomes include liver fat and liver fibrosis (MR elastography), total body fat (DEXA), visceral fat (MRI). Participants will be randomly assigned to 16 weeks of probiotics (3 packets/day of VSL#3) or matched placebo. The main effects of the intervention will be evaluated in a general linear model, with change in outcomes as the dependent variable and active intervention group as the independent variable. Covariates will include sex, BMI percentile, the baseline value of the outcome variable, as well as baseline factors found to differ among groups. Post hoc pairwise comparisons of the two groups will adjust for multiple comparisons using a Tukey correction.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE
  • Obesity, Abdominal
  • Adiposity
Intervention  ICMJE
  • Dietary Supplement: VSL#3
    VSL#3 will provide active packets. Subjects will take 2 to 3 packets per day with for 16 weeks. The study team will supply each participant with all necessary packets on a weekly or bi-weekly basis within 1-2 weeks after their first visit. VSL#3 probiotic is provided in powder form and needs to be mixed with cold, non-fizzy liquid for consumption. For this reason, the study team will also provide participants with zero calorie sugar fee beverages to mix their packet with (e.g., vitamin water zero with stevia).
  • Dietary Supplement: Placebo
    A matched placebo to VSL#3 will be provided. The placebo will be identical to the active VSL#3 probiotic in aspects such as packaging, color, taste, texture, shape, and odor. The placebo will not contain active ingredients. The study team will supply each participant with all necessary packets on a weekly or bi-weekly basis within 1-2 weeks after their first visit. The placebo is provided in powder form and needs to be mixed with liquid for consumption. For this reason, the study team will also provide participants with zero calorie sugar fee beverages to mix their packet with (e.g., vitamin water zero).
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Inactive ingredients include maltose, lemon flavoring (or corn starch if unflavored), and silicon dioxide.
    Intervention: Dietary Supplement: Placebo
  • Active Comparator: VSL#3
    VSL#3 is classified as a medical food that is specially formulated and processed to provide a precise mixture of 8 strains of bacterial species with potential synergistic relationships. These strains include Streptococcus thermophilus, Bifidobacterium breve, Bifidobacterium longum, Bifidobacterium infantis, Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus paracasei, and Lactobacillus delbrueckii subsp. bulgaricus.
    Intervention: Dietary Supplement: VSL#3
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 10, 2017)
22
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 11, 2016
Actual Primary Completion Date April 11, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Inclusion Criteria:

  • Obese (BMI percentile ≥95th for age and gender)
  • Hispanic males and females who are 12-18 years of age and are ≥Tanner Stage 4.

Exclusion Criteria:

Participants will be excluded from the study if any of the following apply:

  1. diagnosis of any disease that is known to influence insulin action and secretion (including type 1 and 2 diabetes);
  2. current or past involvement in any weight loss, exercise, or sports program in the six months prior to participation
  3. use of medication known to influence body composition or fat distribution (e.g. Cushing syndrome), insulin resistance, gut function, or lipid profiles;
  4. history of renal / liver disease or any disease affecting liver fibrosis and steatosis;
  5. diagnosis/current treatment for celiac, inflammatory bowel disease, Crohn's disease or other major GI issues;
  6. those who are immune compromised;
  7. pregnancy;
  8. current smoking (more than 1 cigarette in the past week), >200 cigarettes in lifetime, or use of other recreational drugs;
  9. alcohol consumption;
  10. other siblings in the study;
  11. physician diagnosis of major illness or eating disorder;
  12. physical/cognitive handicaps preventing participation;
  13. and recent antibiotic treatment (within the previous 30 days).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03115385
Other Study ID Numbers  ICMJE HS-14-00683
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Michael I. Goran, University of Southern California
Study Sponsor  ICMJE University of Southern California
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael I Goran, PhD University of Southern California
PRS Account University of Southern California
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP