Gastrointestinal Symptoms Clinical Trial
Official title:
Effects of Shield Nutraceuticals GlutenShield on Short Chain Fatty Acid Production, Gut Microbiota, and Markers of Inflammation in Individuals With GI Symptoms
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.
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