Obesity, AbdominalNCT03115385
Probiotics and the Gut Microbiome in Obese Hispanic Youth
A study testing VSL#3 in people with Obesity, Abdominal and Adiposity, run by University of Southern California at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Abdominal, Adiposity
- What is being tested?
- VSL#3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2015to 11 Apr 2016
- Phase
- Interventional
- 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 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Obese (BMI percentile ≥95th for age and gender)
- Hispanic males and females who are 12-18 years of age and are ≥Tanner Stage 4.
Who cannot join
- 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;
Show all 14Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern California
Los Angeles, California, 90033
About this study
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.
Read the 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.
- Conditions
- Obesity, Abdominal, Adiposity
- Being tested
- VSL#3, Placebo
- Medical subject headings
- Obesity, Abdominal, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VSL#3Dietary 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).
PlaceboDietary 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).
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Inactive ingredients include maltose, lemon flavoring (or corn starch if unflavored), and silicon dioxide. Receives: 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. Receives: Dietary Supplement: VSL#3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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..
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.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start30 May 2015
- Primary completion11 Apr 2016
- Study completion11 Apr 2016
Why it stopped: Funds ended.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Obesity, AbdominalStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael I. Goran, University of Southern California
- Investigators
- Michael I Goran, PhD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03115385
- Sponsor's protocol ID
- HS-14-00683
- Status last verified
- Apr 2017
- First submitted
- 29 Mar 2017
- Last updated
- 14 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 24138544Alisi 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.
PubMed 24738701Eslamparast T, Eghtesad S, Hekmatdoost A, Poustchi H. Probiotics and Nonalcoholic Fatty liver Disease. Middle East J Dig Dis. 2013 Jul;5(3):129-36.
PubMed 24829682Rajkumar 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.
PubMed 24795503Delzenne 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.
PubMed 21826100Wong 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.
PubMed 23396737Kootte 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.
PubMed 21812894Wang 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.
PubMed 24936764
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotics and the Gut Microbiome in Obese Hispanic Youth
- ClinicalTrials.gov ID
- NCT03115385
- Acronym / sponsor ID
- HS-14-00683
- Conditions
- Obesity, Abdominal, Adiposity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funds ended.
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 30 May 2015 (actual)
- Primary completion
- 11 Apr 2016 (actual)
- Study completion
- 11 Apr 2016 (actual)
- First posted
- 14 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboInactive ingredients include maltose, lemon flavoring (or corn starch if unflavored), and silicon dioxide. |
| VSL#3 | Active comparator | Dietary Supplement: VSL#3VSL#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. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Obese (BMI percentile ≥95th for age and gender)
- Hispanic males and females who are 12-18 years of age and are ≥Tanner Stage 4.
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VSL#3VSL#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 | VSL#3 |
| PlaceboA 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). | Dietary supplement | Placebo |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study was stopped early (reason given: Funds ended.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2017.
- Results publication: PubMed 24138544Chang 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 publication: PubMed 24738701Alisi 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 publication: PubMed 24829682Eslamparast 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 publication: PubMed 24795503Rajkumar 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 publication: PubMed 21826100Delzenne 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 publication: PubMed 23396737Wong 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 publication: PubMed 21812894Kootte 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 publication: PubMed 24936764Wang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael I Goran, PhD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VSL#3 in people with Obesity, Abdominal and Adiposity, run by University of Southern California 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 2 inclusion and 14 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: stopped early, as of the sponsor's last update on 14 Apr 2017. 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. Some participants in this study may receive a placebo. 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 stopped early (reason given: Funds ended.). Results are not available in the source record.
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?
Change in abundance of gut microbiome and gut hormones measured pre and post blood and stool sample collections. (time frame: 16 weeks). 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 NCT03115385, which also lists 8 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 14 Apr 2017.