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Status unknownNCT03403387Updated Jan 18, 2018

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

An interventional study of GlutenShield and Placebo in Gastrointestinal Symptoms, sponsored by East Tennessee State University. Status unknown at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-18.

Sponsored by East Tennessee State University · Not applicable, Interventional, and Basic science

The sponsor has not verified this record recently (last verified Jan 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Gastrointestinal Symptoms
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    GlutenShield

    3 capsules of GlutenShield supplement/day for 28 days

    Dietary Supplement: GlutenShield

  • Placebo comparator
    Placebo

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

    Other: Placebo

Interventions

  • Dietary supplementGlutenShield

    combination probiotic, prebiotic, and enzyme supplement

  • OtherPlacebo

    Avicel (cellulose) and bentonite powder

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline and Day 29

  2. Change in Microbial Population and Concentration

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

    Time frame: Baseline and Day 29

  3. 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.

    Time frame: Baseline and Day 29

Secondary outcomes

  1. Dietary Intake

    Identifying typical dietary intake over the past month using Block Food Frequency Questionnaire

    Time frame: Baseline

  2. Physical Activity

    Identifying typical physical activity over the past month using Block Food Frequency Questionnaire

    Time frame: Baseline

  3. Change in Oxidative Stress

    Measuring changes in serum markers of oxidative stress (8-isoprostaglandin F2a)

    Time frame: Baseline and Day 29

  4. Changes in Psychosocial Measures of Self

    Measuring changes in psychosocial measures of self (Profile of Mood States 2nd Edition survey)

    Time frame: Baseline and Day 29

  5. Changes in Adipokine Response

    Measuring changes in adipokine response (Bio-Plex Pro Human Diabetes Adipsin and Adiponectin assays)

    Time frame: Baseline and Day 29

06

Study locations

1 of 1 sites recruiting
  • East Tennessee State University
    Johnson City, Tennessee 37614, United States
    Recruiting
07

References and documents

Individual participant data

Plan to share: No — There is no plan to share individual participant data. Data will be de-identified.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03403387
Lead sponsor
East Tennessee State University
Collaborators
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
Responsible party
Kaitlyn Webb (Graduate Student in Clinical Nutrition, East Tennessee State University) — Principal investigator
First posted
Jan 18, 2018
Start date
Jan 22, 2018 (estimated)
Primary completion
Mar 31, 2018 (estimated)
Completion
Mar 31, 2018 (estimated)
Last update
Jan 18, 2018

Study contacts

Kaitlyn M Webb, BS
Contact
webbkm1@etsu.edu
423-946-0977
Jonathan Peterson, PhD
Contact
petersonjm1@etsu.edu
423-439-4726
Kaitlyn Webb, BS
principal investigator · East Tennessee State University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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