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Microbial Basis of Systemic Malodor and "People Allergic To Me" Conditions (PATM)

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ClinicalTrials.gov Identifier: NCT03582826
Recruitment Status : Completed
First Posted : July 11, 2018
Results First Posted : January 5, 2021
Last Update Posted : January 5, 2021
Sponsor:
Collaborators:
uBiome
Aurametrix
Information provided by (Responsible Party):
Mebo Research, Inc.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition Nutritional and Metabolic Diseases
Interventions Behavioral: Nutritional counselling
Behavioral: Stress-reduction counseling
Enrollment 125
Recruitment Details  
Pre-assignment Details  
Arm/Group Title MEBO/PATM Cohort Non-MEBO/PATM Cohort
Hide Arm/Group Description The cohort is individuals who experienced symptoms of idiopathic malodor (MEBO) and/or PATM ("people allergic to me" condition) Individuals that never experienced MEBO or PATM symptoms that donated their gut microbiome samples
Period Title: Overall Study
Started 119 6
Completed [1] 78 6
Not Completed 41 0
Reason Not Completed
Lost to Follow-up             39             0
Withdrawal by Subject             2             0
[1]
submitted stool samples
Arm/Group Title MEBO/PATM Cohort Non-MEBO/PATM Cohort Total
Hide Arm/Group Description The cohort is 119 individuals who experienced symptoms of idiopathic malodor (MEBO: 70 participants) and/or PATM ("people allergic to me" condition: 39 participants) 6 data volunteers that never experienced episodes of uncontrollable socially debilitating odor or PATM. Total of all reporting groups
Overall Number of Baseline Participants 119 6 125
Hide Baseline Analysis Population Description
Participants at Baseline who consented to submit their data
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 119 participants 6 participants 125 participants
40  (12) 40  (20) 40  (13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 119 participants 6 participants 125 participants
Female
79
  66.4%
1
  16.7%
80
  64.0%
Male
40
  33.6%
5
  83.3%
45
  36.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment   [1] 
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 119 participants 6 participants 125 participants
70 5 75
United Kingdom Number Analyzed 119 participants 6 participants 125 participants
10 0 10
Argentina Number Analyzed 119 participants 6 participants 125 participants
4 0 4
Brazil Number Analyzed 119 participants 6 participants 125 participants
4 0 4
Burkina Faso Number Analyzed 119 participants 6 participants 125 participants
1 0 1
Canada Number Analyzed 119 participants 6 participants 125 participants
5 0 5
Colombia Number Analyzed 119 participants 6 participants 125 participants
1 0 1
France Number Analyzed 119 participants 6 participants 125 participants
1 0 1
Hong Kong Number Analyzed 119 participants 6 participants 125 participants
2 0 2
Italy Number Analyzed 119 participants 6 participants 125 participants
1 0 1
Kenya Number Analyzed 119 participants 6 participants 125 participants
2 0 2
Mexico Number Analyzed 119 participants 6 participants 125 participants
1 0 1
Morocco Number Analyzed 119 participants 6 participants 125 participants
1 0 1
Netherlands Number Analyzed 119 participants 6 participants 125 participants
1 0 1
Nigeria Number Analyzed 119 participants 6 participants 125 participants
3 0 3
Pakistan Number Analyzed 119 participants 6 participants 125 participants
1 0 1
Peru Number Analyzed 119 participants 6 participants 125 participants
2 0 2
Philippines Number Analyzed 119 participants 6 participants 125 participants
1 0 1
Portugal Number Analyzed 119 participants 6 participants 125 participants
1 0 1
South Africa Number Analyzed 119 participants 6 participants 125 participants
1 0 1
Spain Number Analyzed 119 participants 6 participants 125 participants
5 1 6
Sweden Number Analyzed 119 participants 6 participants 125 participants
1 0 1
[1]
Measure Description: Number of participants at Baseline who consented to submit their data
TMAU status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 119 participants 6 participants 125 participants
Primary TMAU
23
  19.3%
0
   0.0%
23
  18.4%
Secondary TMAU
12
  10.1%
0
   0.0%
12
   9.6%
Negative TMAU test result
26
  21.8%
0
   0.0%
26
  20.8%
Not tested for TMAU
58
  48.7%
6
 100.0%
64
  51.2%
[1]
Measure Description: Trimethylaminuria diagnosis at baseline, based on laboratory testing
PATM status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 119 participants 6 participants 125 participants
PATM with or without MEBO
60
  50.4%
0
   0.0%
60
  48.0%
MEBO
59
  49.6%
0
   0.0%
59
  47.2%
neither MEBO nor PATM
0
   0.0%
6
 100.0%
6
   4.8%
[1]
Measure Description: Self-diagnosis of "Metabolic Body Odor" (MEBO) and "People are Allergic to me" (PATM) conditions at baseline
1.Primary Outcome
Title Gut Microbiome
Hide Description Abundance [operational taxonomic units]
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Study volunteers that submitted gut microbiome samples (84 out of 125 enrolled)
Arm/Group Title MEBO/PATM Cohort That Submitted Gut Samples Non-MEBO/PATM Cohort
Hide Arm/Group Description:
Participants who had experienced uncontrollable socially debilitating odor or PATM symptoms and submitted at least one gut sample for analysis (78 out of 119 in MEBO/PATM cohort)
Samples of volunteers that never experienced episodes of uncontrollable socially debilitating odor or PATM.
Overall Number of Participants Analyzed 78 6
Overall Number of Units Analyzed
Type of Units Analyzed: Samples
217 16
Mean (95% Confidence Interval)
Unit of Measure: Normalized OTU counts
Phylum Firmicutes
52
(50 to 53)
64
(63 to 65)
Phylum Bacteroidetes
25
(24 to 26)
33
(32 to 34)
Phylum Tenericutes
0.04
(0.01 to 0.07)
0.35
(0.26 to 0.42)
Phylum Actinobacteria
3.73
(3.25 to 4.22)
3.37
(3.06 to 3.67)
Phylum Proteobacteria
4.64
(4.07 to 5.22)
3.70
(3.21 to 4.18)
2.Secondary Outcome
Title Quality of Life [Score]
Hide Description 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.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Subjects With Active MEBO/PATM Subjects in Regression or Remission
Hide Arm/Group Description:
Individuals experiencing uncontrollable episodes of MEBO or PATM who submitted responses to Quality of Life (QoL) questionnaire.
Individuals self-describing themselves as being in remission or regression of MEBO/PATM (experiencing fewer and less severe flareups or disappearance of the symptoms) who submitted responses to QoL questionnaire.
Overall Number of Participants Analyzed 64 7
Overall Number of Units Analyzed
Type of Units Analyzed: QoL entries
154 34
Mean (95% Confidence Interval)
Unit of Measure: score on a scale
57
(55 to 59)
97
(90 to 105)
3.Secondary Outcome
Title Idiopathic Malodor Episodes
Hide Description The number of flareups after study enrollment
Time Frame 1 year after study enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Subjects With Active MEBO/PATM Subjects in Regression or Remission
Hide Arm/Group Description:
Observations of individuals experiencing uncontrollable episodes of malodor or PATM
Observations of individuals self-reporting remission or regression of MEBO/PATM (lessening of the severity or disappearance of the symptoms)
Overall Number of Participants Analyzed 64 7
Overall Number of Units Analyzed
Type of Units Analyzed: Observations
154 34
Count of Units
Unit of Measure: observations
severe flareups
81
  52.6%
7
  20.6%
moderate flareups
27
  17.5%
12
  35.3%
remission episodes
6
   3.9%
12
  35.3%
not sure
40
  26.0%
3
   8.8%
4.Secondary Outcome
Title Change in Fecal Microbiome Composition Between Flare-ups and Improvements
Hide Description The fecal microbial composition will be measured via taxonomic profiling using 16S ribosomal RNA gene amplicon sequencing of submitted gut samples
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title MEBO/PATM Subcohort After Flare-up MEBO/PATM Subcohort After Improvement
Hide Arm/Group Description:
study participants who experienced flare-ups of MEBO/PATM followed by improvements of their condition documented by corresponding gut samples and QoL questionnaire responses (22 out of 119 in MEBO/PATM cohort)
same study participants who experienced improvement in MEBO/PATM status after flare-ups of this condition and submitted corresponding gut samples and QoL questionnaire responses to document their improvement (22 out of 119 in MEBO/PATM cohort)
Overall Number of Participants Analyzed 22 22
Overall Number of Units Analyzed
Type of Units Analyzed: Samples
43 43
Median (95% Confidence Interval)
Unit of Measure: Normalized OTU counts in gut sample
Selected dermatological bacteria, normalized counts
162
(135 to 502)
15
(6 to 110)
Corynebacteriales order, normalized counts
302
(300 to 1148)
91
(85 to 172)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MEBO/PATM Subcohort After Flare-up, MEBO/PATM Subcohort After Improvement
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Paired Wilcoxon Signed-Rank Tests
Statistical Test of Hypothesis P-Value 0.02
Comments Original p-value for dermatological bacteria was 6e-05. It was adjusted first by applying centered log-ratio (CLR) transformation approach then by false discovery rate (FDR) correction for multiple comparisons by using Benjamini-Hochberg Procedure.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 79
Confidence Interval (2-Sided) 95%
26 to 163
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Alpha Diversity
Hide Description Alpha (within-sample) diversity measure using microbial abundance information in a phylogenetic framework. Represented by abundance-weighted phylogenetic entropy.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Subjects With Active MEBO Subjects With Active PATM Subjects in Regression or Remission Non MEBO/PATM Cohort
Hide Arm/Group Description:
Individuals experiencing uncontrollable episodes of malodor that did not self-diagnose PATM
Individuals experiencing uncontrollable episodes of PATM with or without malodor
Individuals self-reporting remission or regression of MEBO/PATM (lessening of the severity or disappearance of the symptoms)
individuals that never experienced MEBO/PATM episodes
Overall Number of Participants Analyzed 38 33 23 6
Overall Number of Units Analyzed
Type of Units Analyzed: Gut microbiome samples
97 85 35 16
Mean (95% Confidence Interval)
Unit of Measure: unitless
1.7
(1.6 to 1.8)
1.6
(1.0 to 2.2)
1.7
(1.6 to 1.8)
1.9
(1.8 to 2.0)
Time Frame participants were observed for one year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Study Participants
Hide Arm/Group Description 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.
All-Cause Mortality
Study Participants
Affected / at Risk (%)
Total   0/125 (0.00%) 
Hide Serious Adverse Events
Study Participants
Affected / at Risk (%)
Total   0/125 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Study Participants
Affected / at Risk (%)
Total   0/125 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Maria De la Torre, Executive Director
Organization: MEBO Research
Phone: 786 228-6880
EMail: maria.delatorre@meboresearch.org
Publications of Results:
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
Layout table for additonal information
Responsible Party: Mebo Research, Inc.
ClinicalTrials.gov Identifier: NCT03582826    
Other Study ID Numbers: 201805110018MEBO
First Submitted: June 11, 2018
First Posted: July 11, 2018
Results First Submitted: August 31, 2020
Results First Posted: January 5, 2021
Last Update Posted: January 5, 2021