Gastrointestinal Symptoms
Conditions
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTGlutenShield
combination probiotic, prebiotic, and enzyme supplement
OTHERPlacebo
Avicel (cellulose) and bentonite powder
Sponsors
East Tennessee State University, College of Clinical and Rehabilitative Health Sciences
East Tennessee State University, College of Public Health, Department of Health Sciences
Shield Nutraceuticals
East Tennessee State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Caregiver)
Intervention model description
Half of the participants will be randomized to receive the supplement and the other half will receive the placebo.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fermentation Profile- Short Chain Fatty Acid Concentration | Baseline and Day 29 | Measuring change short chain fatty acid concentrations in fecal matter (analyzed using gas chromatography) from baseline to after 28 days. |
| Change in Microbial Population and Concentration | Baseline and Day 29 | Measuring change from baseline of fecal microbial populations and concentrations (using genomic sequencing). |
| Change in Inflammation | Baseline and Day 29 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Psychosocial Measures of Self | Baseline and Day 29 | Measuring changes in psychosocial measures of self (Profile of Mood States 2nd Edition survey) |
| Dietary Intake | Baseline | Identifying typical dietary intake over the past month using Block Food Frequency Questionnaire |
| Changes in Adipokine Response | Baseline and Day 29 | Measuring changes in adipokine response (Bio-Plex Pro Human Diabetes Adipsin and Adiponectin assays) |
| Physical Activity | Baseline | Identifying typical physical activity over the past month using Block Food Frequency Questionnaire |
| Change in Oxidative Stress | Baseline and Day 29 | Measuring changes in serum markers of oxidative stress (8-isoprostaglandin F2a) |
Countries
United States
Contacts
Primary ContactKaitlyn M Webb, BS
Backup ContactJonathan Peterson, PhD
Outcome results
None listed