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

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ClinicalTrials.gov Identifier: NCT03403387
Recruitment Status : Recruiting
First Posted : January 18, 2018
Last Update Posted : January 18, 2018
Sponsor:
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
Information provided by (Responsible Party):
Kaitlyn Webb, 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.

Condition or disease Intervention/treatment Phase
Gastrointestinal Symptoms Dietary Supplement: GlutenShield Other: Placebo Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Half of the participants will be randomized to receive the supplement and the other half will receive the placebo.
Masking: Double (Participant, Care Provider)
Primary Purpose: Basic Science
Official Title: Effects of Shield Nutraceuticals GlutenShield on Short Chain Fatty Acid Production, Gut Microbiota, and Markers of Inflammation in Individuals With GI Symptoms
Estimated Study Start Date : January 22, 2018
Estimated Primary Completion Date : March 31, 2018
Estimated Study Completion Date : March 31, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Change in Fermentation Profile- Short Chain Fatty Acid Concentration [ Time Frame: Baseline and Day 29 ]
    Measuring change short chain fatty acid concentrations in fecal matter (analyzed using gas chromatography) from baseline to after 28 days.

  2. Change in Microbial Population and Concentration [ Time Frame: Baseline and Day 29 ]
    Measuring change from baseline of fecal microbial populations and concentrations (using genomic sequencing).

  3. Change in Inflammation [ Time Frame: 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 Outcome Measures :
  1. Dietary Intake [ Time Frame: Baseline ]
    Identifying typical dietary intake over the past month using Block Food Frequency Questionnaire

  2. Physical Activity [ Time Frame: Baseline ]
    Identifying typical physical activity over the past month using Block Food Frequency Questionnaire

  3. Change in Oxidative Stress [ Time Frame: Baseline and Day 29 ]
    Measuring changes in serum markers of oxidative stress (8-isoprostaglandin F2a)

  4. Changes in Psychosocial Measures of Self [ Time Frame: Baseline and Day 29 ]
    Measuring changes in psychosocial measures of self (Profile of Mood States 2nd Edition survey)

  5. Changes in Adipokine Response [ Time Frame: Baseline and Day 29 ]
    Measuring changes in adipokine response (Bio-Plex Pro Human Diabetes Adipsin and Adiponectin assays)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03403387


Contacts
Contact: Kaitlyn M Webb, BS 423-946-0977 webbkm1@etsu.edu
Contact: Jonathan Peterson, PhD 423-439-4726 petersonjm1@etsu.edu

Locations
United States, Tennessee
East Tennessee State University Recruiting
Johnson City, Tennessee, United States, 37614
Contact: Kaitlyn Webb, BS    423-946-0977    webbkm1@etsu.edu   
Sponsors and Collaborators
East Tennessee State University
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

Responsible Party: Kaitlyn Webb, Graduate Student in Clinical Nutrition, East Tennessee State University
ClinicalTrials.gov Identifier: NCT03403387     History of Changes
Other Study ID Numbers: 1117.22f
First Posted: January 18, 2018    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share individual participant data. Data will be de-identified.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No