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Prebiotic, Probiotic, and Enzyme Supplement

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

N/A
Waitlist Available
Led By Kaitlyn Webb, BS
Research Sponsored by East Tennessee State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and day 29

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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and day 29
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and day 29 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Fermentation Profile- Short Chain Fatty Acid Concentration
Change in Inflammation
Change in Microbial Population and Concentration
Secondary study objectives
Change in Oxidative Stress
Changes in Adipokine Response
Changes in Psychosocial Measures of Self
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: GlutenShieldExperimental Treatment1 Intervention
3 capsules of GlutenShield supplement/day for 28 days
Group II: PlaceboPlacebo Group1 Intervention
3 capsules of the placebo (Avicel and bentonite powder (for color))/ day for 28 days

Find a Location

Who is running the clinical trial?

East Tennessee State UniversityLead Sponsor
22 Previous Clinical Trials
3,010 Total Patients Enrolled
East Tennessee State University, College of Clinical and Rehabilitative Health SciencesUNKNOWN
Shield NutraceuticalsUNKNOWN
East Tennessee State University, College of Public Health, Department of Health SciencesUNKNOWN
Kaitlyn Webb, BSPrincipal InvestigatorEast Tennessee State University
~3 spots leftby Dec 2025
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