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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-22

Study Completion Date

2018-03-31

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.

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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.

Conditions

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Gastrointestinal Symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Half of the participants will be randomized to receive the supplement and the other half will receive the placebo.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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GlutenShield

3 capsules of GlutenShield supplement/day for 28 days

Group Type EXPERIMENTAL

GlutenShield

Intervention Type DIETARY_SUPPLEMENT

combination probiotic, prebiotic, and enzyme supplement

Placebo

3 capsules of the placebo (Avicel and bentonite powder (for color))/ day for 28 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Avicel (cellulose) and bentonite powder

Interventions

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GlutenShield

combination probiotic, prebiotic, and enzyme supplement

Intervention Type DIETARY_SUPPLEMENT

Placebo

Avicel (cellulose) and bentonite powder

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes