Clinical trial NCT03533621: Gut Microbiome, Adiposity, and Probiotics (GMAP)
Official title: The Effect of Probiotics on Gut Microbiome and Adiposity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Childhood
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: Rady Children's Hospital
First posted: 2018-05-23
Enrollment: 45
Sex: ALL
Minimum age (years): 7
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects were randomized to probiotic or placebo group, and remained in that group for the 12 week study period.
Primary purpose: OTHER

Brief summary: Recent studies have shown that the bacteria in the gut (gut microbiome) can affect adiposity levels and inflammation. In animal studies, changing these bacteria has been linked with decreased fat mass and inflammation as well as improved metabolism. Probiotics can be a safe method of altering the gut microbiome in humans and have shown promising results in adults with regards to changing adiposity and inflammatory markers. However, it may also be important to provide the right dietary milieu (i.e. high fruit and vegetable/low saturated fat diet) in order to see the benefits of probiotics on these physiologic markers. At this time, no one has offered probiotics in the context of the right dietary milieu and tested it in children. This pilot proposal is innovative because it will be the first to test how well probiotics work in the context of a diet high in fruits and vegetables to change the gut microbiome, decrease fat mass, and improve inflammatory markers in overweight/obese children. This protocol will allow one to better understand the effect of probiotics on these physiologic functions and determine acceptability and feasibility of taking daily probiotics.

Detailed description: The goal is to study the effect of probiotics on changing the gut microbiome of overweight/obese children. Since there appears to be a diet-by-microbiota interaction for optimal effects on adiposity, it will be important to administer the probiotics within the context of increased fruit/vegetable (F/V) intake and decreased fat intake. Because changes in diet alone can also induce changes in the gut microbiota, this study will use a double-blind, randomized, placebo-control design to determine whether changes in gut microbiota are greater with the addition of probiotics (High F/V diet + Probiotics) compared to diet alone (High F/V diet + Placebo). The primary aim is to test the effect of these 2 arms on changing the gut microbiota, fat mass, and inflammation in children. The study will also examine the acceptability of taking probiotics and changes in other physiologic measures.

The Specific aims of this proposal are:

1. To examine the effect of diet high in F/V +/- probiotics on change in gut microbiota, adiposity, and inflammation (measured by C-reactive protein, TNF-a, and IL-6);
2. To examine the effect of diet high in F/V +/- probiotics on physiologic measures including blood pressure, fasting insulin and glucose, and adiponectin;
3. To determine the acceptability and feasibility of taking daily probiotics over a 12 week period.

Eligibility criteria: Inclusion Criteria:

* BMI \>= 85th percentile
* 7-16 years old
* parent willing to participate

Exclusion Criteria:

* 1) taking any oral or topical antibiotics or probiotics within the last month prior to the start of the intervention, 2) allergy to milk or milk products, 3) taking any diabetes medication, lipid-lowering drugs, or anti-inflammatory drugs, 4) be immune compromised; 5) 5% weight change or greater within the last three months, 6) psychiatric or medical illness that would hinder their ability to participate in weekly sessions, 7) receiving treatment for a major psychiatric disorder, including an eating disorder, 8) developmental delay such that the intervention materials will not be appropriate, and 9) the possibility of moving out of the area within the time frame of the study.

Primary outcomes:
measure: Adiposity
timeFrame: 12 weeks
measure: hsCRP
timeFrame: 12 weeks
measure: IL-6
timeFrame: 12 weeks
measure: TNF-alpha
timeFrame: 12 weeks
measure: Adiponectin
timeFrame: 12 weeks
measure: Acceptability of taking pills
timeFrame: week 12
measure: Proportion of participants with side effects
timeFrame: 12 weeks
Secondary outcomes:
measure: Bristol Stool chart
timeFrame: 12 weeks
measure: gut microbiome
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
References: