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

Not Applicable

• Conditions: Gastrointestinal Symptoms
• Interventions: Other: Placebo; Dietary Supplement: GlutenShield

• Registration Number: NCT03403387
• Lead Sponsor: East Tennessee State University

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.

Study Timeline

• Status Verified: 2018-01
• Study First Submitted: 2018-01-05
• Study First Submitted QC: 2018-01-17
• Last Update Submitted: 2018-01-17
• Study First Posted: 2018-01-18
• Last Update Posted: 2018-01-18
• Study Start: 2018-01-22
• Primary Completion: 2018-03-31
• Study Completion: 2018-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	3 capsules of the placebo (Avicel and bentonite powder (for color))/ day for 28 days
GlutenShield	GlutenShield	3 capsules of GlutenShield supplement/day for 28 days

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
Change in Oxidative Stress	Baseline and Day 29	Measuring changes in serum markers of oxidative stress (8-isoprostaglandin F2a)
Changes in Psychosocial Measures of Self	Baseline and Day 29	Measuring changes in psychosocial measures of self (Profile of Mood States 2nd Edition survey)
Physical Activity	Baseline	Identifying typical physical activity over the past month using Block Food Frequency Questionnaire
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)

Trial Locations

Locations (1)

East Tennessee State University; 🇺🇸 Johnson City, Tennessee, United States