Effects of GlutenShield, a Prebiotic, Probiotic, and Enzyme Supplement, on the Gut Microbiome of Adults With GI Symptoms
Status unconfirmed · Not applicable · Has a placebo group
Conditions studied: Gastrointestinal Symptoms
In brief
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.
Key facts
- Study ID
- NCT03403387
- Run by
- East Tennessee State University
- People needed
- 20
- Starts
- 2018-01-22
- Expected to finish
- 2018-03-31
- Last updated by the study team
- 2018-01-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- East Tennessee State University — Johnson City, Tennessee, United States (enrolling)
Full record on ClinicalTrials.gov
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