Status:
UNKNOWN
Effects of GlutenShield, a Prebiotic, Probiotic, and Enzyme Supplement, on the Gut Microbiome of Adults With GI Symptoms
Lead Sponsor:
East Tennessee State University
Collaborating Sponsors:
East Tennessee State University, College of Clinical and Rehabilitative Health Sciences
East Tennessee State University, College of Public Health, Department of Health Sciences
Conditions:
Gastrointestinal Symptoms
Eligibility:
All Genders
18+ years
Phase:
NA
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)....
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 sp...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 22 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2018
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03403387
Start Date
January 22 2018
End Date
March 31 2018
Last Update
January 18 2018
Active Locations (1)
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1
East Tennessee State University
Johnson City, Tennessee, United States, 37614