This study evaluates the effects of combination probiotic, prebiotic, and enzyme supplementation on the colonic microbiome of individuals with GI symptoms (e.g. diarrhea, constipation, increased gas). Half of the participants will receive the placebo while the other half will receive the supplement for 28 days.
The purpose of this research is to identify if there is a relationship between GlutenShield, a combination prebiotic, probiotic, and enzyme supplement, and the gut environment. The study will be a split, 28-day randomized, partially blinded design. Subjects will be randomly assigned to one of two groups. One group will complete a 28-day treatment period with GlutenShield taken 3x/day with meals. The other group will complete a 28-day placebo period with the placebo taken 3x/day with meals. The placebo will contain Avicel (cellulose) and bentonite powder (to have a similar color as GlutenShield). Participants will be blinded to which group/ treatment they are being given. Serum and fecal samples will be collected at baseline and on day 29. Participants will also complete a gastrointestinal symptoms questionnaire, a food frequency questionnaire and a psychosocial measures of self questionnaire.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
20
combination probiotic, prebiotic, and enzyme supplement
Avicel (cellulose) and bentonite powder
East Tennessee State University
Johnson City, Tennessee, United States
RECRUITINGChange in Fermentation Profile- Short Chain Fatty Acid Concentration
Measuring change short chain fatty acid concentrations in fecal matter (analyzed using gas chromatography) from baseline to after 28 days.
Time frame: Baseline and Day 29
Change in Microbial Population and Concentration
Measuring change from baseline of fecal microbial populations and concentrations (using genomic sequencing).
Time frame: Baseline and Day 29
Change in Inflammation
Measuring change in serum markers of inflammation (IgA and IgG, GM-CSF, IFN-γ, IL-2, IL-4, IL-6, IL-8, IL-10, TNF-α) over 28 days. Values will be used to determine a change in overall inflammatory status.
Time frame: Baseline and Day 29
Dietary Intake
Identifying typical dietary intake over the past month using Block Food Frequency Questionnaire
Time frame: Baseline
Physical Activity
Identifying typical physical activity over the past month using Block Food Frequency Questionnaire
Time frame: Baseline
Change in Oxidative Stress
Measuring changes in serum markers of oxidative stress (8-isoprostaglandin F2a)
Time frame: Baseline and Day 29
Changes in Psychosocial Measures of Self
Measuring changes in psychosocial measures of self (Profile of Mood States 2nd Edition survey)
Time frame: Baseline and Day 29
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Changes in Adipokine Response
Measuring changes in adipokine response (Bio-Plex Pro Human Diabetes Adipsin and Adiponectin assays)
Time frame: Baseline and Day 29