Examining the Change in Microbiome Diversity & Urine Metabolites After

Status Recruiting

Clinical Trial Summary

The purpose of this study is to determine whether or not 'Restore' lignite extract mineral supplement impacts the microbiome composition of the mouth and gut. Additionally, participant urine samples will be examined to determine whether or not 'Restore' mineral supplement impacts the composition urine biomarkers and toxins.

Clinical Trial Description

OBJECTIVES:

The purpose of this study is to determine whether or not 'Restore' lignite extract mineral supplement impacts the microbiome composition of the mouth and gut. Additionally, participant urine samples will be examined to determine whether or not 'Restore' mineral supplement impacts the composition urine biomarkers and toxins.

BACKGROUND & RATIONALE There is mounting evidence that the composition of the microbiome can change quickly. Unpublished case reports have shown significant shifts in the microbiome when participant's diet changes from a high carbohydrate to a high fat diet. Clinically, the use of 'Restore' mineral supplement has led to the bulking of stool in people using it for the first time within one or two days of first dose, further indicating a change in the gut microbiome.

Given these observations, this clinical trial was designed to examine how taking 'Restore' mineral supplement may impact the microbiome by examining the gut bacteria composition at two days, and again at two weeks. Our hypothesis is that taking Restore alone can lead to a quantifiable shift in the diversity of the microbiome as measured by the Simpson's Diversity Index, a mathematical measure of species diversity in a community. This index provides more information about community composition than simply species richness by also taking into account the relative abundances of different species.

There is also evidence that Restore mineral supplement can impact urine composition. Specifically, we will be examining the change in the presence of zonulin, glyphosate, creatinine-albumin ratio, and stem cells. ;

Study Design

Related Conditions & MeSH terms

Microbiome

Clinical Trial Details

NCT number	NCT03026621
Study type	Interventional
Source	Seraphic Group Inc
Contact	David Roberts, MPH
Phone	844 432-5488
Email	droberts@seraphicgroup.com
Status	Recruiting
Phase	N/A
Start date	January 2017
Completion date	March 2017

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT03586622` - One Year Home Monitoring and Treatment of IBS Patients	N/A
Active, not recruiting	`NCT04552834` - Alterations of the Microbiome During Critical Illness With Short and Long Term Clinical Outcomes
Completed	`NCT03201068` - Probiotic Supplement and Microbiome, Immune System and Metabolic Syndrome	N/A
Completed	`NCT04217122` - Effect of Strawberry Consumption on the Microbiome	N/A
Recruiting	`NCT05545631` - Frozen Embryo Transfer Pregnancy Outcomes Prediction by Microbiome and Transcriptome
Recruiting	`NCT05521295` - Frozen Embryo Transfer Pregnancy Outcomes Prediction by Microbiome
Not yet recruiting	`NCT05852145` - Oral Changes With Caloric and no Caloric Sweeteners	Phase 1/Phase 2
Withdrawn	`NCT04099446` - A Non-Interventional Pilot Study to Explore the Skin Microbes in Skin Cancer
Recruiting	`NCT05445544` - A Multicenter Cohort Study on Maternal and Infant Microecology and New Targets for Pre-eclampsia Screening in China
Active, not recruiting	`NCT03213275` - The Premature Gut Microbiome and the Influence on Neonatal Immunity, Brain Development and White Matter Injury
Recruiting	`NCT05505110` - MOdification Of THe Early-Life Respiratory Microbiome Through Vaginal SEEDing	N/A
Completed	`NCT04851340` - Investigating the Detection of Bovine and Soy Proteins in Human Milk	N/A
Completed	`NCT06133400` - Mapping the Health Status of the Population of French Polynesia: the MATAEA Project	N/A
Withdrawn	`NCT04114513` - Dietary Fibers Effect on the Gut Microbiota Composition	N/A
Not yet recruiting	`NCT05612620` - Elucidating the Microbiome in Patients With Recurrent Pregnancy Loss
Completed	`NCT04611945` - Westlake Sailing Cohort
Recruiting	`NCT04260295` - Study of the Correlation of Tumor Tissue Microbiome to the Pathogenesis of Lung Cancer
Completed	`NCT04155684` - Dysbiosis Impact on Lung Disease in HIV
Active, not recruiting	`NCT06424691` - Infant Restore: Efficacy of Microbiome Analysis and Education	N/A
Completed	`NCT05510050` - Comparison Study of Manapol and DaltonMax on Immune Function, Microbiome, and Related Variables in Men and Women	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Examining the Change in Microbiome Diversity and Urine Metabolites After Lignite Extract Use

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms