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Probiotics and the Gut Microbiome in Obese Hispanic Youth

Primary Purpose

Obesity, Abdominal, Adiposity

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VSL#3
Placebo
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Obesity, Abdominal

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • University of Southern California

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

VSL#3

Arm Description

Inactive ingredients include maltose, lemon flavoring (or corn starch if unflavored), and silicon dioxide.

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.

Outcomes

Primary Outcome Measures

Change in abundance of gut microbiome and gut hormones measured pre and post blood and stool sample collections.
To determine whether probiotic (VSL#3) supplementation affects gut microbiome and gut hormones involved with appetite regulation in obese young Hispanics.

Secondary Outcome Measures

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..
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.

Full Information

First Posted
March 29, 2017
Last Updated
April 10, 2017
Sponsor
University of Southern California
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1. Study Identification

Unique Protocol Identification Number
NCT03115385
Brief Title
Probiotics and the Gut Microbiome in Obese Hispanic Youth
Official Title
Probiotics and the Gut Microbiome in Obese Hispanic Youth
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Why Stopped
Funds ended.
Study Start Date
May 30, 2015 (Actual)
Primary Completion Date
April 11, 2016 (Actual)
Study Completion Date
April 11, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Abdominal, Adiposity

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Inactive ingredients include maltose, lemon flavoring (or corn starch if unflavored), and silicon dioxide.
Arm Title
VSL#3
Arm Type
Active Comparator
Arm Description
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 Type
Dietary Supplement
Intervention Name(s)
VSL#3
Intervention Description
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).
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in abundance of gut microbiome and gut hormones measured pre and post blood and stool sample collections.
Description
To determine whether probiotic (VSL#3) supplementation affects gut microbiome and gut hormones involved with appetite regulation in obese young Hispanics.
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
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..
Description
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.
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: diagnosis of any disease that is known to influence insulin action and secretion (including type 1 and 2 diabetes); current or past involvement in any weight loss, exercise, or sports program in the six months prior to participation use of medication known to influence body composition or fat distribution (e.g. Cushing syndrome), insulin resistance, gut function, or lipid profiles; history of renal / liver disease or any disease affecting liver fibrosis and steatosis; diagnosis/current treatment for celiac, inflammatory bowel disease, Crohn's disease or other major GI issues; those who are immune compromised; pregnancy; current smoking (more than 1 cigarette in the past week), >200 cigarettes in lifetime, or use of other recreational drugs; alcohol consumption; other siblings in the study; physician diagnosis of major illness or eating disorder; physical/cognitive handicaps preventing participation; and recent antibiotic treatment (within the previous 30 days).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael I Goran, PhD
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24138544
Citation
Chang B, Sang L, Wang Y, Tong J, Zhang D, Wang B. The protective effect of VSL#3 on intestinal permeability in a rat model of alcoholic intestinal injury. BMC Gastroenterol. 2013 Oct 20;13:151. doi: 10.1186/1471-230X-13-151.
Results Reference
result
PubMed Identifier
24738701
Citation
Alisi A, Bedogni G, Baviera G, Giorgio V, Porro E, Paris C, Giammaria P, Reali L, Anania F, Nobili V. Randomised clinical trial: The beneficial effects of VSL#3 in obese children with non-alcoholic steatohepatitis. Aliment Pharmacol Ther. 2014 Jun;39(11):1276-85. doi: 10.1111/apt.12758. Epub 2014 Apr 16.
Results Reference
result
PubMed Identifier
24829682
Citation
Eslamparast T, Eghtesad S, Hekmatdoost A, Poustchi H. Probiotics and Nonalcoholic Fatty liver Disease. Middle East J Dig Dis. 2013 Jul;5(3):129-36.
Results Reference
result
PubMed Identifier
24795503
Citation
Rajkumar H, Mahmood N, Kumar M, Varikuti SR, Challa HR, Myakala SP. Effect of probiotic (VSL#3) and omega-3 on lipid profile, insulin sensitivity, inflammatory markers, and gut colonization in overweight adults: a randomized, controlled trial. Mediators Inflamm. 2014;2014:348959. doi: 10.1155/2014/348959. Epub 2014 Mar 26.
Results Reference
result
PubMed Identifier
21826100
Citation
Delzenne NM, Neyrinck AM, Backhed F, Cani PD. Targeting gut microbiota in obesity: effects of prebiotics and probiotics. Nat Rev Endocrinol. 2011 Aug 9;7(11):639-46. doi: 10.1038/nrendo.2011.126.
Results Reference
result
PubMed Identifier
23396737
Citation
Wong VW, Won GL, Chim AM, Chu WC, Yeung DK, Li KC, Chan HL. Treatment of nonalcoholic steatohepatitis with probiotics. A proof-of-concept study. Ann Hepatol. 2013 Mar-Apr;12(2):256-62.
Results Reference
result
PubMed Identifier
21812894
Citation
Kootte RS, Vrieze A, Holleman F, Dallinga-Thie GM, Zoetendal EG, de Vos WM, Groen AK, Hoekstra JB, Stroes ES, Nieuwdorp M. The therapeutic potential of manipulating gut microbiota in obesity and type 2 diabetes mellitus. Diabetes Obes Metab. 2012 Feb;14(2):112-20. doi: 10.1111/j.1463-1326.2011.01483.x. Epub 2011 Nov 22.
Results Reference
result
PubMed Identifier
24936764
Citation
Wang J, Tang H, Zhang C, Zhao Y, Derrien M, Rocher E, van-Hylckama Vlieg JE, Strissel K, Zhao L, Obin M, Shen J. Modulation of gut microbiota during probiotic-mediated attenuation of metabolic syndrome in high fat diet-fed mice. ISME J. 2015 Jan;9(1):1-15. doi: 10.1038/ismej.2014.99. Epub 2014 Jun 17.
Results Reference
result

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Probiotics and the Gut Microbiome in Obese Hispanic Youth

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