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

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.

Study Overview

• Status: Unknown
• Conditions: Gastrointestinal Symptoms
• Intervention / Treatment: Dietary supplement: GlutenShield; Other: Placebo

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kaitlyn M Webb, BS; Phone Number: 423-946-0977; Email: webbkm1@etsu.edu
• Study Contact Backup: Name: Jonathan Peterson, PhD; Phone Number: 423-439-4726; Email: petersonjm1@etsu.edu

Study Locations

• United States
  • Tennessee
    • Johnson City, Tennessee, United States, 37614
      • Recruiting
      • East Tennessee State University
      • Contact: Kaitlyn Webb, BS; Phone Number: 423-946-0977; Email: webbkm1@etsu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: GlutenShield; 3 capsules of GlutenShield supplement/day for 28 days	Dietary supplement: GlutenShield; combination probiotic, prebiotic, and enzyme supplement
PLACEBO_COMPARATOR: Placebo; 3 capsules of the placebo (Avicel and bentonite powder (for color))/ day for 28 days	Other: Placebo; Avicel (cellulose) and bentonite powder

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: East Tennessee State University
• Collaborators: 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
• Investigators: Principal Investigator: Kaitlyn Webb, BS, East Tennessee State University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 22, 2018
• Primary Completion (ANTICIPATED): March 31, 2018
• Study Completion (ANTICIPATED): March 31, 2018

Study Registration Dates

• First Submitted: January 5, 2018
• First Submitted That Met QC Criteria: January 17, 2018
• First Posted (ACTUAL): January 18, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 18, 2018
• Last Update Submitted That Met QC Criteria: January 17, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 1117.22f

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share individual participant data. Data will be de-identified.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No