Gastrointestinal SymptomsNCT03403387
Effects of GlutenShield, a Prebiotic, Probiotic, and Enzyme Supplement, on the Gut Microbiome of Adults With GI Symptoms
A study testing GlutenShield in people with Gastrointestinal Symptoms, run by East Tennessee State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Symptoms
- What is being tested?
- GlutenShield
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jan 2018to 31 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
East Tennessee State University
Johnson City, Tennessee, 37614
Kaitlyn Webb, BS, 423-946-0977, webbkm1@etsu.edu
About this study
Official title: Effects of Shield Nutraceuticals GlutenShield on Short Chain Fatty Acid Production, Gut Microbiota, and Markers of Inflammation in Individuals With GI Symptoms
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.
- Conditions
- Gastrointestinal Symptoms
- Being tested
- GlutenShield, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlutenShieldDietary supplement
combination probiotic, prebiotic, and enzyme supplement
PlaceboOther
Avicel (cellulose) and bentonite powder
| Study group | Role | What they receive |
|---|---|---|
| GlutenShield | Experimental | 3 capsules of GlutenShield supplement/day for 28 days Receives: Dietary Supplement: GlutenShield |
| Placebo | Placebo comparator | 3 capsules of the placebo (Avicel and bentonite powder (for color))/ day for 28 days Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Day 29
Change in Microbial Population and Concentration
Measuring change from baseline of fecal microbial populations and concentrations (using genomic sequencing).
Measured: 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.
Measured: Baseline and Day 29
Secondary outcomes (5)
Dietary Intake
Identifying typical dietary intake over the past month using Block Food Frequency Questionnaire
Measured: Baseline
Physical Activity
Identifying typical physical activity over the past month using Block Food Frequency Questionnaire
Measured: Baseline
Change in Oxidative Stress
Measuring changes in serum markers of oxidative stress (8-isoprostaglandin F2a)
Measured: Baseline and Day 29
Changes in Psychosocial Measures of Self
Measuring changes in psychosocial measures of self (Profile of Mood States 2nd Edition survey)
Measured: Baseline and Day 29
Changes in Adipokine Response
Measuring changes in adipokine response (Bio-Plex Pro Human Diabetes Adipsin and Adiponectin assays)
Measured: Baseline and Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2018
- Study start22 Jan 2018 (estimated)
- Primary completion31 Mar 2018 (estimated)
- Study completion31 Mar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Half of the participants will be randomized to receive the supplement and the other half will receive the placebo.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- East Tennessee State University
- Sponsor type
- University, hospital or other
- Collaborators
- Shield Nutraceuticals
- Responsible party
- Principal investigator, Kaitlyn Webb, East Tennessee State University
- Investigators
- Kaitlyn Webb, BS, Principal investigator, East Tennessee State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03403387
- Sponsor's protocol ID
- 1117.22f
- Status last verified
- Jan 2018
- First submitted
- 5 Jan 2018
- Last updated
- 18 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data. Data will be de-identified.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Shield Nutraceuticals GlutenShield on Short Chain Fatty Acid Production, Gut Microbiota, and Markers of Inflammation in Individuals With GI Symptoms
- ClinicalTrials.gov ID
- NCT03403387
- Acronym / sponsor ID
- 1117.22f
- Conditions
- Gastrointestinal Symptoms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- East Tennessee State UniversityUniversity, hospital or other
- Collaborators
- Shield Nutraceuticals
- Study start
- 22 Jan 2018 (estimated)
- Primary completion
- 31 Mar 2018 (estimated)
- Study completion
- 31 Mar 2018 (estimated)
- First posted
- 18 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Half of the participants will be randomized to receive the supplement and the other half will receive the placebo.
| Arm | Type | Receives |
|---|---|---|
| GlutenShield | Experimental | Dietary Supplement: GlutenShield3 capsules of GlutenShield supplement/day for 28 days |
| Placebo | Placebo comparator | Other: Placebo3 capsules of the placebo (Avicel and bentonite powder (for color))/ day for 28 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GlutenShieldcombination probiotic, prebiotic, and enzyme supplement | Dietary supplement | GlutenShield |
| PlaceboAvicel (cellulose) and bentonite powder | Other | Placebo |
Primary outcome
Change in Fermentation Profile- Short Chain Fatty Acid Concentration
Time frame: Baseline and Day 29
Measuring change short chain fatty acid concentrations in fecal matter (analyzed using gas chromatography) from baseline to after 28 days.
Change in Microbial Population and Concentration
Time frame: Baseline and Day 29
Measuring change from baseline of fecal microbial populations and concentrations (using genomic sequencing).
Change in Inflammation
Time frame: Baseline and Day 29
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.
5 secondary outcomes
Dietary Intake
Time frame: Baseline
Physical Activity
Time frame: Baseline
Change in Oxidative Stress
Time frame: Baseline and Day 29
Changes in Psychosocial Measures of Self
Time frame: Baseline and Day 29
Changes in Adipokine Response
Time frame: Baseline and Day 29
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2018.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data. Data will be de-identified.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kaitlyn Webb, BS principal investigator
East Tennessee State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GlutenShield in people with Gastrointestinal Symptoms, run by East Tennessee State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kaitlyn M Webb, BS (423-946-0977, webbkm1@etsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fermentation Profile- Short Chain Fatty Acid Concentration (time frame: Baseline and Day 29). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2018.