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MEBO - UBIOME study 2018

NCT03582826
ClinicalTrials.gov
MEBO Gut Microbiome Study
Funded by uBiome Research Grant

"Microbial Basis of Systemic Malodor and PATM Conditions (PATM)"

Dynamics of the Gut Microbiota in
Idiopathic Malodor Production
& PATM

Started May 2018 - Ongoing

Current people sent kits : 100/100
3 kits per person

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Metabolomic Profiling Study
NCT02683876

Start : Aug 2016
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Thursday, February 1, 2018

Results MEBO clinical trial published in clinicaltrials.gov

“What if very minor faults in your enzymes
and slightly imbalanced microbes in your body...


...one of our tests [NCT02692495] was able to clearly separate those groups, bad breath and body odor, based on the intestinal permeability test. Those with increased permeabilidad tended to be exhibiting body odor, and those with decreased [intestinal permeability] compared to normal showed to be exhibiting bad breath.

Definitely this test cannot be used to diagnose body odor, but at least it can show and demonstrate that whatever the sufferers is actually exhibiting is real. They [the tests used in the study] can very accurately pinpoint the source, which is also very important...

The odor are also very reliable symptoms...sour odor symptoms [are] like garbage, fishy ammonia, acetone, are odors associated with alcoholism, and fecal diarrhea and generic fecal odor. The sweet group symptoms mostly include sulfur smells like sulfur, rotten vegetables, rotten eggs, cheesy sweaty, fecal, sewage, smoke of gasoline burning...and the PATM condition with a lot more interesting observations, but not much time to talk about it...

The sweet group had more added sugar in their diet. They were more likely to experience improvement in symptoms when they reduced sweet intake. The participants from the sweet group were more likely to improve with probiotics, but of course, it is more complicated than that...

The application for research funding from the U.S. National Institutes of Health (NIH), All of Us Research Program, submitted by Irene Gabashvili, PhD., will be the next research step to the two clinical trials mentioned in her video, which she has carried out with the MEBO Community. Anyone anywhere around the world could vote and comment! The deadline for submitting your vote and comments is February 23, 2018. Consideration for all entries will be discussed at the All of US Research Priorities Workshop on March 21–23, 2018, to identify key research priorities. As MEBO members, you can use MEBO's address information if necessary, including zip code 33175, and remain anonymous.

Please help us go to the next phase of this research by voting and commenting on Irene's NIH research grant proposal by February 23, 2018. Get your family and friends to vote too! As MEBO members, you can use MEBO's address information if necessary, including zip code 33175, and remain anonymous. http://www.meboblog.com/2018/01/support-all-of-us-research-program.html

In April 2009, under the direction of the MEBO Scientific Director, Irene Gabashvili, PhD, MEBO started a clinical trial with Biolab Medical Unit UK with the goal of the evaluation of gastrointestinal and nutritional diagnostic tests as potential screening tools for metabolic body odor and halitosis. Dr. Gabashvili published the results of this study in ClinicalTrials.gov on January 24, 2018. The specific diagnostic tests used for this study were the following:
  1. The Gut Permeability Profile, 
  2. Fermentation Profile, 
  3. D-lactate test, 
  4. the urine indicans (Obermeyer) test, the breath test for small intestinal dysbiosis, and,
  5. the Functional B vitamins profile. 
Nineteen posts have been written in this MEBO Blog with discussions of each subject's study test results, under the Label, Biolab Gut Dysbiosis Study. To see all these posts in the blog, it is necessary to scroll down and click on 'Older Posts' at the bottom of the page to go to the following page.

STUDY DETAILS

Brief Summary:

This study is designed as a retrospective cohort study to evaluate the potential of diagnostic procedures in defining populations of patients self-reporting unexpected and uncontrollable episodes of body odor and/or halitosis. The cohort - generally healthy individuals who had underwent multiple diagnostic tests recommended by their physicians and had not been diagnosed with any known medical condition - expressed their interest in trying gastrointestinal and nutritional diagnostic tests offered by Biolab Medical Unit. Our retrospective analysis will determine if these tests were useful as potential screening tools for metabolic body odor and halitosis.

Detailed Description:

Diagnostic tests included:

  • Gut Permeability Profile. PEG 400 is used as a probe and measured in urine passed for the following 6 hours at 11 different molecular weights to establish the quantity of each absorbed through the gut wall. Extraction and separation of PEG from urine is done by ion exchange chromatography and capillary GLC.
  • Gut Fermentation Profile. Blood alcohols - ethanol, methanol, butanol, propanol and short chain fatty acids - are measured by gas-liquid chromatography.
  • D-lactate test. D-lactate is measured by centrifugal analysis using the specific enzyme D-lactate dehydrogenase, which does not react with L-lactate
  • The urine indicans (Obermeyer) test. Detection of indican in the urine depends upon its decomposition and subsequent oxidation of indoxyl to indigo blue and its absorption into a chloroform layer
  • Breath test for small intestinal dysbiosis. Breath hydrogen and methane are measured by gas-liquid chromatography. The patient is given 10 gm of lactulose in 200 ml of water and alveolar air samples are collected every 20 minutes for 3 hours
  • Functional B vitamins profile, by measuring the activation of a red cell enzyme that is dependent upon an adequate concentration of a particular vitamin for full activity. The assay relies on normal metabolism of the vitamin to its native form and the presence of other non-vitamin cofactors.

Study Results : Outcome Measures

Primary Outcome Measures:

  1. Number of Test Results Outside the Normal Range [ Time Frame: four years ]
  2. The investigators would like to evaluate the strength of evidence in diagnostic accuracy of laboratory tests taken by participants (listed in the detailed description of the study), for diagnosing malodor syndromes. Values measured by the laboratory (Biolab Medical Unit) will be compared against the reference range specific to that laboratory.

Secondary Outcome Measures:

  1. Discriminative Biomarkers in the Subgroups of Malodor [ Time Frame: three years ]
  2. The investigators have comprehensively analyzed diagnostic ability of tests taken by participants to correlate with their symptoms using several statistical techniques known to bring out strong patterns in a dataset. Principal component analysis (PCA) allowed to clearly separate data into two clusters ("Sour" and "Sweet") shown below along with the "Lactic" subgroup from the "Sour" group.
  3. Number of Test Results Outside the Normal Range in Different Subgroups of Malodor [ Time Frame: Three years ]
  4. Disciminative biomarkers for groups of malodor discovered using PCA, compared to control group
  5. Dietary Biomarkers in the Subgroups of Malodor [ Time Frame: Three years ] The measurement of dietary intake by self-report. Correlation of symptoms with added sugar in the diet were noted independently on the source of malodor.

It is MEBO Research's intentions to move forward in research under the leadership of Irene Gabashvili to develop a comprehensive Test Profile for metabolic body odor and halitosis conditions in order for physicians to be able to arrive at precise diagnoses of specific odor conditions, to then research further for precision medicine initiatives as proper and effective treatment for each and all of these conditions.
Our most profound gratitude goes to Irene Gabashvili for the countless hours she has volunteered to assist MEBO Research in this and other research trials. Without her dedication to our community, this study would not have been possible. Our gratitude also goes to the 16 volunteers for their personal contribution to this study.

It is MEBO Research's intentions to move forward in research under the leadership of Irene Gabashvili to develop a comprehensive Test Profile for metabolic body odor and halitosis conditions in order for physicians to be able to arrive at precise diagnoses of specific odor conditions, to then research further for precision medicine initiatives as proper and effective treatment for each and all of these conditions. Please help us go to the next phase of this research by voting and commenting on Irene's NIH research grant proposal by February 23, 2018. Get your family and friends to vote too! http://www.meboblog.com/2018/01/support-all-of-us-research-program.html

María

María de la Torre
Founder and Executive Director

A Public Charity
maria.delatorre@meboresearch.com
www.meboresearch.org
www.mebo.com.br/
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