Clinical trial NCT03403387: Effects of GlutenShield, a Prebiotic, Probiotic, and Enzyme Supplement, on the Gut Microbiome of Adults With GI Symptoms
Official title: Effects of Shield Nutraceuticals GlutenShield on Short Chain Fatty Acid Production, Gut Microbiota, and Markers of Inflammation in Individuals With GI Symptoms
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastrointestinal Symptoms
Lead sponsor: East Tennessee State University
Sponsor class: OTHER
Collaborators: name: East Tennessee State University, College of Clinical and Rehabilitative Health Sciences
name: East Tennessee State University, College of Public Health, Department of Health Sciences
name: Shield Nutraceuticals
First posted: 2018-01-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Half of the participants will be randomized to receive the supplement and the other half will receive the placebo.
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in Fermentation Profile- Short Chain Fatty Acid Concentration
timeFrame: Baseline and Day 29
measure: Change in Microbial Population and Concentration
timeFrame: Baseline and Day 29
measure: Change in Inflammation
timeFrame: Baseline and Day 29
Secondary outcomes:
measure: Dietary Intake
timeFrame: Baseline
measure: Physical Activity
timeFrame: Baseline
measure: Change in Oxidative Stress
timeFrame: Baseline and Day 29
measure: Changes in Psychosocial Measures of Self
timeFrame: Baseline and Day 29
measure: Changes in Adipokine Response
timeFrame: Baseline and Day 29
Other outcomes:
Locations:
city: Johnson City
country: United States
facility: East Tennessee State University
state: Tennessee
Study officials:
affiliation: East Tennessee State University
name: Kaitlyn Webb, BS
role: PRINCIPAL_INVESTIGATOR
References: