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

Gastrointestinal Symptoms Clinical Trial

Official title:

Effects of Shield Nutraceuticals GlutenShield on Short Chain Fatty Acid Production, Gut Microbiota, and Markers of Inflammation in Individuals With GI Symptoms

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03403387
• Other study ID #: 1117.22f
• Status: Recruiting
• Phase: N/A
• First received: January 5, 2018
• Last updated: January 17, 2018
• Start date: January 22, 2018
• Est. completion date: March 31, 2018

Study information

• Verified date: January 2018
• Source: East Tennessee State University
• Contact: Kaitlyn M Webb, BS
• Phone: 423-946-0977
• Email: webbkm1[@]etsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 31, 2018
• Est. primary completion date: March 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastrointestinal Symptoms

Intervention

Dietary Supplement:
• GlutenShield
combination probiotic, prebiotic, and enzyme supplement

Other:
• Placebo
Avicel (cellulose) and bentonite powder

Locations

Country	Name	City	State
United States	East Tennessee State University	Johnson City	Tennessee

Sponsors (4)

Lead Sponsor	Collaborator
East Tennessee State University	East Tennessee State University, College of Clinical and Rehabilitative Health Sciences, East Tennessee State University, College of Public Health, Department of Health Sciences, Shield Nutraceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Fermentation Profile- Short Chain Fatty Acid Concentration	Measuring change short chain fatty acid concentrations in fecal matter (analyzed using gas chromatography) from baseline to after 28 days.	Baseline and Day 29
Primary	Change in Microbial Population and Concentration	Measuring change from baseline of fecal microbial populations and concentrations (using genomic sequencing).	Baseline and Day 29
Primary	Change in Inflammation	Measuring change in serum markers of inflammation (IgA and IgG, GM-CSF, IFN-?, IL-2, IL-4, IL-6, IL-8, IL-10, TNF-a) over 28 days. Values will be used to determine a change in overall inflammatory status.	Baseline and Day 29
Secondary	Dietary Intake	Identifying typical dietary intake over the past month using Block Food Frequency Questionnaire	Baseline
Secondary	Physical Activity	Identifying typical physical activity over the past month using Block Food Frequency Questionnaire	Baseline
Secondary	Change in Oxidative Stress	Measuring changes in serum markers of oxidative stress (8-isoprostaglandin F2a)	Baseline and Day 29
Secondary	Changes in Psychosocial Measures of Self	Measuring changes in psychosocial measures of self (Profile of Mood States 2nd Edition survey)	Baseline and Day 29
Secondary	Changes in Adipokine Response	Measuring changes in adipokine response (Bio-Plex Pro Human Diabetes Adipsin and Adiponectin assays)	Baseline and Day 29