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| Name | Class |
|---|---|
| uBiome | INDUSTRY |
| Aurametrix | OTHER |
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The purpose of this study is to identify microbial signatures associated with remission and recurrence of idiopathic malodor and PATM conditions.
Human odorprints, mostly owing to the microbiome, have proven their value as biomarkers of health and environmental exposures. In recent years, microbial networks responsible for localized malodors such as halitosis or axillary odor have been mapped by using next generation sequencing approaches. Intestinal microbes responsible for psychologically debilitating systemic malodor (whole-body and extraoral halitosis), however, remain to be identified. Even a relatively straightforward disorder of choline metabolism trimethylaminuria (TMAU) is thought to exhibit complex host-gene microbiome interactions and has not been sufficiently studied.
Proposed controlled pilot study aims to explore the dynamics of microbial communities in remission and flare-up periods. Better knowledge of the important aspects of disease fluctuation should enhance patient care and, combined with our prior data, will help to develop new therapies and treatments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MEBO/PATM cohort | Experimental | Nutrition counselling and stress-management counselling behavioral interventions will be given to minimize subjects symptoms and observe corresponding changes in their microbiomes. The following subcohorts were formed for analyses of different outcomes: MEBO and PATM subcohorts, TMAU positive and negative subcohorts, Active MEBO, Active PATM, Regression and Remission; MEBO/PATM Cohort that Submitted Gut Samples, MEBO/PATM cohort that answered QoL survey, MEBO/PATM Subcohort that observed and documented both flareups and improvements. |
|
| non-MEBO cohort | No Intervention | Data volunteers that never experienced episodes of uncontrollable socially debilitating metabolic body odor (MEBO) or PATM |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutritional counselling | Behavioral | Behavioral nutritional counselling delivered via the Internet. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gut Microbiome | Abundance [operational taxonomic units] | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life [Score] | QoL: Scores range from 20 (lowest level of satisfaction with life) to 150 (maximal life satisfaction). Quality of life (QOL) will be measured with MEBO quality of life assessment questionnaire, a new tool designed on the basis of the Halitosis Associated Life-quality Test (HALT), Dermatology Life Quality Index (DLQI) and WHOQOL-100 questionnaires. Most questions were devised with a Likert scale of 0-5 where a higher score indicated a higher quality of life. Scores for five negatively framed questions are transformed to positively framed questions. Total QOL score (minimum score of 20 and maximum score of 150) is computed based on four aspects of QOL: physical health, psychological health, social support and environment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Irene Gabashvili, PhD | MeBO Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MeBO Research | Miami | Florida | 33175 | United States | ||
| MeBO Research LTD |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Gabashvili IS Cutaneous Bacteria in the Gut Microbiome as Biomarkers of Systemic Malodor and People Are Allergic to Me (PATM) Conditions: Insights From a Virtually Conducted Clinical Trial JMIR Dermatol 2020;3(1):e10508 URL: http://derma.jmir.org/2020/1/e10508/ doi: 10.2196/10508 |
| Label | URL |
|---|---|
| uBiome Awards Grant to MEBO Research | View source |
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Deidentified patient data will be made partially available when approved by the study sponsor.
one year after completion of the study
undecided
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| ID | Title | Description |
|---|---|---|
| FG000 | MEBO/PATM Cohort | The cohort is individuals who experienced symptoms of idiopathic malodor (MEBO) and/or PATM ("people allergic to me" condition) |
| FG001 | Non-MEBO/PATM Cohort | Individuals that never experienced MEBO or PATM symptoms that donated their gut microbiome samples |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants at Baseline who consented to submit their data
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| ID | Title | Description |
|---|---|---|
| BG000 | MEBO/PATM Cohort | The cohort is 119 individuals who experienced symptoms of idiopathic malodor (MEBO: 70 participants) and/or PATM ("people allergic to me" condition: 39 participants) |
| BG001 | Non-MEBO/PATM Cohort |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Gut Microbiome | Abundance [operational taxonomic units] | Study volunteers that submitted gut microbiome samples (84 out of 125 enrolled) | Posted | Mean | 95% Confidence Interval | Normalized OTU counts | 1 year | samples | samples |
|
participants were observed for one year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Study Participants | The cohort is individuals who consented to submit stool samples, including those who experienced symptoms of idiopathic malodor or PATM ("people allergic to me" condition) and received the support-group intervention. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maria De la Torre, Executive Director | MEBO Research | 786 228-6880 | maria.delatorre@meboresearch.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 6, 2018 | Aug 22, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 12, 2018 | Aug 22, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009750 | Nutritional and Metabolic Diseases |
| D000089083 | Body Odor |
| D006209 | Halitosis |
| D008286 | Malabsorption Syndromes |
| D064806 | Dysbiosis |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
| D007410 | Intestinal Diseases |
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| Stress-reduction counseling | Behavioral | The psycho-behavioral intervention includes administering questionnaires and monthly maintenance psychological support delivered via the Internet. |
|
| 1 year |
| Idiopathic Malodor Episodes | The number of flareups after study enrollment | 1 year after study enrollment |
| Change in Fecal Microbiome Composition Between Flare-ups and Improvements | The fecal microbial composition will be measured via taxonomic profiling using 16S ribosomal RNA gene amplicon sequencing of submitted gut samples | 1 year |
| Alpha Diversity | Alpha (within-sample) diversity measure using microbial abundance information in a phylogenetic framework. Represented by abundance-weighted phylogenetic entropy. | 1 year |
| London |
| England |
| W10 5LE |
| United Kingdom |
6 data volunteers that never experienced episodes of uncontrollable socially debilitating odor or PATM.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number of participants at Baseline who consented to submit their data | Number | participants |
|
| TMAU status | Trimethylaminuria diagnosis at baseline, based on laboratory testing | Count of Participants | Participants |
|
| PATM status | Self-diagnosis of "Metabolic Body Odor" (MEBO) and "People are Allergic to me" (PATM) conditions at baseline | Count of Participants | Participants |
|
|
|
| Secondary | Quality of Life [Score] | QoL: Scores range from 20 (lowest level of satisfaction with life) to 150 (maximal life satisfaction). Quality of life (QOL) will be measured with MEBO quality of life assessment questionnaire, a new tool designed on the basis of the Halitosis Associated Life-quality Test (HALT), Dermatology Life Quality Index (DLQI) and WHOQOL-100 questionnaires. Most questions were devised with a Likert scale of 0-5 where a higher score indicated a higher quality of life. Scores for five negatively framed questions are transformed to positively framed questions. Total QOL score (minimum score of 20 and maximum score of 150) is computed based on four aspects of QOL: physical health, psychological health, social support and environment. | Study participants from MEBO/PATM cohort that answered QoL survey (71 out of 119 in MEBO/PATM cohort). Since QOL questionnaire was administered multiple times for each participant, type of units analyzed is number of QoL submissions. Non MEBO/PATM cohort did not participate in this intervention. | Posted | Mean | 95% Confidence Interval | score on a scale | 1 year | QoL entries | QoL entries |
|
|
|
| Secondary | Idiopathic Malodor Episodes | The number of flareups after study enrollment | Individuals from MEBO/PATM cohort who submitted at least one gut microbiome sample accompanied by a QoL survey. Non-MEBO Cohort is not included since they never experienced MEBO/PATM flareups. | Posted | Count of Units | observations | 1 year after study enrollment | observations | observations |
|
|
|
| Secondary | Change in Fecal Microbiome Composition Between Flare-ups and Improvements | The fecal microbial composition will be measured via taxonomic profiling using 16S ribosomal RNA gene amplicon sequencing of submitted gut samples | Study participants that submitted two or more microbiome samples (each accompanied by answers to QoL questionnaire) and observed improvement of their symptoms (22 participants that documented their improvement out of 119 participants in MEBO/PATM cohort). Participants from "Non-MEBO Cohort" are not included since they did not participate in the intervention; there was no difference between their entries in terms of flareups or improvements of MEBO/PATM conditions. | Posted | Median | 95% Confidence Interval | Normalized OTU counts in gut sample | 1 year | samples | samples |
|
|
|
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| Secondary | Alpha Diversity | Alpha (within-sample) diversity measure using microbial abundance information in a phylogenetic framework. Represented by abundance-weighted phylogenetic entropy. | Participants that submitted valid stool samples. Since 16 individuals who observed improvement of their symptoms changed the status of their MEBO/PATM condition from "active" to "remission/regression", their samples were grouped in two subgroups (38+33+23+6 = 84+16) Units analyzed represents samples submitted, 233 total. | Posted | Mean | 95% Confidence Interval | unitless | 1 year | gut microbiome samples | gut microbiome samples |
|
|
|
| 0 |
| 125 |
| 0 |
| 125 |
| 0 |
| 125 |
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| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D008659 | Metabolic Diseases |
| D010335 | Pathologic Processes |
| Negative TMAU test result |
|
| Not tested for TMAU |
|
| neither MEBO nor PATM |
|
| remission episodes |
|
| not sure |
|
| gut microbiome samples |
|