Effects of GlutenShield, a Prebiotic, Probiotic, and Enzyme Supplement, on the Gut Microbiome of Adults With GI Symptoms

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects of Shield Nutraceuticals GlutenShield on Short Chain Fatty Acid Production, Gut Microbiota, and Markers of Inflammation in Individuals With GI Symptoms

Conditions
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Gastrointestinal Symptoms

Intervention / Treatment
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* Dietary Supplement: GlutenShield
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals who express gastrointestinal symptoms more than three times per week as identified through the Gastrointestinal Symptom Questionnaire (such as abdominal pain/ discomfort, heartburn, acid regurgitation, bloating, nausea and vomiting, abdominal distention, eructation (burping), increased gas, decreased passage of stools, increased passage of stools, loose stools, hard stools, urgent need for defecation, or feeling of incomplete evacuation) Healthy with few health complications Adults ages 18 or older Exclusion Criteria: Anyone under the age of 18 Individuals diagnosed with celiacs, IBS, Crohn's disease, ulcerative colitis, or short bowel syndrome Individuals who have previously taken GlutenShield Individuals who are currently taking prebiotics, probiotics, enzymes, non-steroidal anti-inflammatory drugs, fish oil, and/or fiber supplements (unless use is halted in the voluntary 2-week washout period prior to the study) Individuals who are pregnant or intend to become pregnant during the duration of the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Half of the participants will be randomized to receive the supplement and the other half will receive the placebo.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GlutenShield<br>3 capsules of GlutenShield supplement/day for 28 days | Dietary Supplement: GlutenShield<br>* combination probiotic, prebiotic, and enzyme supplement<br>|
| Placebo Comparator: Placebo<br>3 capsules of the placebo (Avicel and bentonite powder (for color))/ day for 28 days | Other: Placebo<br>* Avicel (cellulose) and bentonite powder<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change 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. | Baseline and Day 29 | 
| Change in Microbial Population and Concentration | Measuring change from baseline of fecal microbial populations and concentrations (using genomic sequencing). | 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. | Baseline and Day 29 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dietary Intake | Identifying typical dietary intake over the past month using Block Food Frequency Questionnaire | Baseline | 
| Physical Activity | Identifying typical physical activity over the past month using Block Food Frequency Questionnaire | Baseline | 
| Change in Oxidative Stress | Measuring changes in serum markers of oxidative stress (8-isoprostaglandin F2a) | Baseline and Day 29 | 
| Changes in Psychosocial Measures of Self | Measuring changes in psychosocial measures of self (Profile of Mood States 2nd Edition survey) | Baseline and Day 29 | 
| Changes in Adipokine Response | Measuring changes in adipokine response (Bio-Plex Pro Human Diabetes Adipsin and Adiponectin assays) | Baseline and Day 29 |