Probiotics and the Gut Microbiome in Obese Hispanic Youth

NCT03115385 | Terminated

• 1 other identifier: HS-14-00683
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity, Abdominal; Adiposity

Outcome Measures

Primary Outcomes (1)

• 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.

  16 weeks

Secondary Outcomes (1)

• 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..

  16 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

VSL#3

ACTIVE COMPARATOR

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.

Dietary Supplement: VSL#3

Interventions

VSL#3 DIETARY_SUPPLEMENT

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).

VSL#3

Placebo DIETARY_SUPPLEMENT

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).

Placebo

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

University of Southern California

Los Angeles, California, 90033, United States

Location

Related Publications (8)

• 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.

  PMID: 24138544 RESULT

• 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.

  PMID: 24738701 RESULT

• 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.

  PMID: 24829682 RESULT

• 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.

  PMID: 24795503 RESULT

• 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.

  PMID: 21826100 RESULT

• 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.

  PMID: 23396737 RESULT

• 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.

  PMID: 21812894 RESULT

• 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.

  PMID: 24936764 RESULT

MeSH Terms

Conditions

Obesity, Abdominal; Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Michael I Goran, PhD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 29, 2017
• First Posted: April 14, 2017
• Study Start: May 30, 2015
• Primary Completion: April 11, 2016
• Study Completion: April 11, 2016
• Last Updated: April 14, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)