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Prebiotic, Probiotic, and Enzyme Supplement

GlutenShield for Gastrointestinal 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
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and day 29
Awards & highlights

Study 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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Fermentation Profile- Short Chain Fatty Acid Concentration
Change in Inflammation
Change in Microbial Population and Concentration
Secondary outcome measures
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
2,980 Total Patients Enrolled
East Tennessee State University, College of Clinical and Rehabilitative Health SciencesUNKNOWN
Shield NutraceuticalsUNKNOWN

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~3 spots leftby Mar 2025