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

NCT03403387 | Unknown DMC

• 1 other identifier: 1117.22f
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Symptoms

Outcome Measures

Primary Outcomes (3)

• 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

• Change in Microbial Population and Concentration

  Measuring change from baseline of fecal microbial populations and concentrations (using genomic sequencing).

  Baseline and Day 29

• Change in Inflammation

  Measuring change in serum markers of inflammation (IgA and IgG, GM-CSF, IFN-γ, IL-2, IL-4, IL-6, IL-8, IL-10, TNF-α) over 28 days. Values will be used to determine a change in overall inflammatory status.

  Baseline and Day 29

Secondary Outcomes (5)

• Dietary Intake

  Baseline

• Physical Activity

  Baseline

• Change in Oxidative Stress

  Baseline and Day 29

• Changes in Psychosocial Measures of Self

  Baseline and Day 29

• Changes in Adipokine Response

  Baseline and Day 29

Study Arms (2)

GlutenShield

EXPERIMENTAL

3 capsules of GlutenShield supplement/day for 28 days

Dietary Supplement: GlutenShield

Placebo

PLACEBO COMPARATOR

3 capsules of the placebo (Avicel and bentonite powder (for color))/ day for 28 days

Other: Placebo

Interventions

GlutenShield DIETARY_SUPPLEMENT

combination probiotic, prebiotic, and enzyme supplement

GlutenShield

Placebo OTHER

Avicel (cellulose) and bentonite powder

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• East Tennessee State University: lead
• East Tennessee State University, College of Clinical and Rehabilitative Health Sciences: collaborator
• East Tennessee State University, College of Public Health, Department of Health Sciences: collaborator
• Shield Nutraceuticals: collaborator

Study Sites (1)

East Tennessee State University

Johnson City, Tennessee, 37614, United States

RECRUITING

Study Officials

• Kaitlyn Webb, BS

  East Tennessee State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kaitlyn M Webb, BS

CONTACT

423-946-0977; webbkm1@etsu.edu

Jonathan Peterson, PhD

CONTACT

423-439-4726; petersonjm1@etsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Graduate Student in Clinical Nutrition

Model Details: Half of the participants will be randomized to receive the supplement and the other half will receive the placebo.

Study Record Dates

• First Submitted: January 5, 2018
• First Posted: January 18, 2018
• Study Start: January 22, 2018
• Primary Completion: March 31, 2018
• Study Completion: March 31, 2018
• Last Updated: January 18, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)