Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03403387
Other study ID # 1117.22f
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT05831527 - An Exploratory Investigation of a Supplement to Promote Gut Health N/A
Completed NCT03659747 - Effect of Probiotic Supplementation on Lactose Maldigestion Induced by Fat-free Milk N/A
Recruiting NCT05972291 - Mechanisms of Gulf War Illness N/A
Completed NCT02054455 - Proton Pump Inhibitors and Gastrointestinal Symptoms Phase 4
Completed NCT03959722 - The Effect of Probiotics on GI Symptoms N/A
Recruiting NCT03514784 - Combination Probiotic: BB-12 With LGG (Different Doses) in Treating Children With Autism Spectrum Disorder Phase 1/Phase 2
Completed NCT01927900 - The Effects Of HMO On The Faecal Microbiota And On Gastrointestinal Symptoms In Healthy Volunteers N/A
Recruiting NCT04919265 - Mother-Infant Cohort Study in Malaysia and China
Completed NCT01171014 - Effect of Bifidobacterium Lactis HN019 on Colonic Transit Time and Digestive Symptoms Phase 2/Phase 3
Completed NCT00574197 - Enteric-coated Mycophenolate Sodium (Myfortic®) in Heart Transplant Recipients Phase 4
Completed NCT01964599 - Potato Fiber and Gastrointestinal Function: Phase 3 N/A
Recruiting NCT06248177 - Probiotic Effect on Gastrointestinal Symptoms (FLORABIOTIC REFUERZO). N/A
Withdrawn NCT04228003 - Pendulum D2D Glucose Control for Adults With Type 2 Diabetes N/A
Recruiting NCT06425094 - Effects of a Microalgae Extract Dietary Supplement on Gut Health, Anxiety, and Immune Function Phase 1
Completed NCT03714464 - Effect of Physical Form of Apples on Gastrointestinal Function and Satiety: a MRI Study N/A
Active, not recruiting NCT03696953 - The Efficacy of Probiotics to Reduce Antepartum Group B Streptococcus Colonization. Phase 2
Completed NCT02277431 - Probiotic Supplementation Among Adults With Recurrent Gastrointestinal Symptoms Phase 2/Phase 3
Completed NCT00677378 - Transient Receptor Potential Vanilloid One (TRPV1) Receptor Expression in Children With Retrosternal Pain N/A
Completed NCT03685552 - Safety Evaluation of a Diet and Nutritional Supplementation Program- Purify 2.0 N/A
Completed NCT01184456 - A Controlled Trial to Evaluate the Effects of GanedenBC30 on the Immune System Phase 2