Effects of GlutenShield, a Prebiotic, Probiotic, and Enzyme Supplement, on the Gut Microbiome of Adults With GI Symptoms
| Status: | Recruiting |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/20/2018 |
| Start Date: | January 22, 2018 |
| End Date: | March 31, 2018 |
| Contact: | Kaitlyn M Webb, BS |
| Email: | webbkm1@etsu.edu |
| Phone: | 423-946-0977 |
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.
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.
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.
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
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