Trial Outcomes & Findings for Microbial Basis of Systemic Malodor and "People Allergic To Me" Conditions (NCT NCT03582826)
NCT ID: NCT03582826
Last Updated: 2021-01-05
Results Overview
Abundance \[operational taxonomic units\]
COMPLETED
NA
125 participants
1 year
2021-01-05
Participant Flow
Participant milestones
| Measure |
MEBO/PATM Cohort
The cohort is individuals who experienced symptoms of idiopathic malodor (MEBO) and/or PATM ("people allergic to me" condition)
|
Non-MEBO/PATM Cohort
Individuals that never experienced MEBO or PATM symptoms that donated their gut microbiome samples
|
|---|---|---|
|
Overall Study
STARTED
|
119
|
6
|
|
Overall Study
COMPLETED
|
78
|
6
|
|
Overall Study
NOT COMPLETED
|
41
|
0
|
Reasons for withdrawal
| Measure |
MEBO/PATM Cohort
The cohort is individuals who experienced symptoms of idiopathic malodor (MEBO) and/or PATM ("people allergic to me" condition)
|
Non-MEBO/PATM Cohort
Individuals that never experienced MEBO or PATM symptoms that donated their gut microbiome samples
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
39
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
MEBO/PATM Cohort
n=119 Participants
The cohort is 119 individuals who experienced symptoms of idiopathic malodor (MEBO: 70 participants) and/or PATM ("people allergic to me" condition: 39 participants)
|
Non-MEBO/PATM Cohort
n=6 Participants
6 data volunteers that never experienced episodes of uncontrollable socially debilitating odor or PATM.
|
Total
n=125 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40 years
STANDARD_DEVIATION 12 • n=119 Participants
|
40 years
STANDARD_DEVIATION 20 • n=6 Participants
|
40 years
STANDARD_DEVIATION 13 • n=125 Participants
|
|
Sex: Female, Male
Female
|
79 Participants
n=119 Participants
|
1 Participants
n=6 Participants
|
80 Participants
n=125 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=119 Participants
|
5 Participants
n=6 Participants
|
45 Participants
n=125 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
70 participants
n=119 Participants
|
5 participants
n=6 Participants
|
75 participants
n=125 Participants
|
|
Region of Enrollment
United Kingdom
|
10 participants
n=119 Participants
|
0 participants
n=6 Participants
|
10 participants
n=125 Participants
|
|
Region of Enrollment
Argentina
|
4 participants
n=119 Participants
|
0 participants
n=6 Participants
|
4 participants
n=125 Participants
|
|
Region of Enrollment
Brazil
|
4 participants
n=119 Participants
|
0 participants
n=6 Participants
|
4 participants
n=125 Participants
|
|
Region of Enrollment
Burkina Faso
|
1 participants
n=119 Participants
|
0 participants
n=6 Participants
|
1 participants
n=125 Participants
|
|
Region of Enrollment
Canada
|
5 participants
n=119 Participants
|
0 participants
n=6 Participants
|
5 participants
n=125 Participants
|
|
Region of Enrollment
Colombia
|
1 participants
n=119 Participants
|
0 participants
n=6 Participants
|
1 participants
n=125 Participants
|
|
Region of Enrollment
France
|
1 participants
n=119 Participants
|
0 participants
n=6 Participants
|
1 participants
n=125 Participants
|
|
Region of Enrollment
Hong Kong
|
2 participants
n=119 Participants
|
0 participants
n=6 Participants
|
2 participants
n=125 Participants
|
|
Region of Enrollment
Italy
|
1 participants
n=119 Participants
|
0 participants
n=6 Participants
|
1 participants
n=125 Participants
|
|
Region of Enrollment
Kenya
|
2 participants
n=119 Participants
|
0 participants
n=6 Participants
|
2 participants
n=125 Participants
|
|
Region of Enrollment
Mexico
|
1 participants
n=119 Participants
|
0 participants
n=6 Participants
|
1 participants
n=125 Participants
|
|
Region of Enrollment
Morocco
|
1 participants
n=119 Participants
|
0 participants
n=6 Participants
|
1 participants
n=125 Participants
|
|
Region of Enrollment
Netherlands
|
1 participants
n=119 Participants
|
0 participants
n=6 Participants
|
1 participants
n=125 Participants
|
|
Region of Enrollment
Nigeria
|
3 participants
n=119 Participants
|
0 participants
n=6 Participants
|
3 participants
n=125 Participants
|
|
Region of Enrollment
Pakistan
|
1 participants
n=119 Participants
|
0 participants
n=6 Participants
|
1 participants
n=125 Participants
|
|
Region of Enrollment
Peru
|
2 participants
n=119 Participants
|
0 participants
n=6 Participants
|
2 participants
n=125 Participants
|
|
Region of Enrollment
Philippines
|
1 participants
n=119 Participants
|
0 participants
n=6 Participants
|
1 participants
n=125 Participants
|
|
Region of Enrollment
Portugal
|
1 participants
n=119 Participants
|
0 participants
n=6 Participants
|
1 participants
n=125 Participants
|
|
Region of Enrollment
South Africa
|
1 participants
n=119 Participants
|
0 participants
n=6 Participants
|
1 participants
n=125 Participants
|
|
Region of Enrollment
Spain
|
5 participants
n=119 Participants
|
1 participants
n=6 Participants
|
6 participants
n=125 Participants
|
|
Region of Enrollment
Sweden
|
1 participants
n=119 Participants
|
0 participants
n=6 Participants
|
1 participants
n=125 Participants
|
|
TMAU status
Primary TMAU
|
23 Participants
n=119 Participants
|
0 Participants
n=6 Participants
|
23 Participants
n=125 Participants
|
|
TMAU status
Secondary TMAU
|
12 Participants
n=119 Participants
|
0 Participants
n=6 Participants
|
12 Participants
n=125 Participants
|
|
TMAU status
Negative TMAU test result
|
26 Participants
n=119 Participants
|
0 Participants
n=6 Participants
|
26 Participants
n=125 Participants
|
|
TMAU status
Not tested for TMAU
|
58 Participants
n=119 Participants
|
6 Participants
n=6 Participants
|
64 Participants
n=125 Participants
|
|
PATM status
PATM with or without MEBO
|
60 Participants
n=119 Participants
|
0 Participants
n=6 Participants
|
60 Participants
n=125 Participants
|
|
PATM status
MEBO
|
59 Participants
n=119 Participants
|
0 Participants
n=6 Participants
|
59 Participants
n=125 Participants
|
|
PATM status
neither MEBO nor PATM
|
0 Participants
n=119 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=125 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Study volunteers that submitted gut microbiome samples (84 out of 125 enrolled)
Abundance \[operational taxonomic units\]
Outcome measures
| Measure |
MEBO/PATM Cohort That Submitted Gut Samples
n=217 samples
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)
|
Non-MEBO/PATM Cohort
n=16 samples
Samples of volunteers that never experienced episodes of uncontrollable socially debilitating odor or PATM.
|
Subjects in Regression or Remission
Individuals self-reporting remission or regression of MEBO/PATM (lessening of the severity or disappearance of the symptoms)
|
Non MEBO/PATM Cohort
individuals that never experienced MEBO/PATM episodes
|
|---|---|---|---|---|
|
Gut Microbiome
Phylum Firmicutes
|
52 Normalized OTU counts
Interval 50.0 to 53.0
|
64 Normalized OTU counts
Interval 63.0 to 65.0
|
—
|
—
|
|
Gut Microbiome
Phylum Tenericutes
|
0.04 Normalized OTU counts
Interval 0.01 to 0.07
|
0.35 Normalized OTU counts
Interval 0.26 to 0.42
|
—
|
—
|
|
Gut Microbiome
Phylum Actinobacteria
|
3.73 Normalized OTU counts
Interval 3.25 to 4.22
|
3.37 Normalized OTU counts
Interval 3.06 to 3.67
|
—
|
—
|
|
Gut Microbiome
Phylum Proteobacteria
|
4.64 Normalized OTU counts
Interval 4.07 to 5.22
|
3.70 Normalized OTU counts
Interval 3.21 to 4.18
|
—
|
—
|
|
Gut Microbiome
Phylum Bacteroidetes
|
25 Normalized OTU counts
Interval 24.0 to 26.0
|
33 Normalized OTU counts
Interval 32.0 to 34.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 yearPopulation: 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.
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.
Outcome measures
| Measure |
MEBO/PATM Cohort That Submitted Gut Samples
n=154 QoL entries
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)
|
Non-MEBO/PATM Cohort
n=34 QoL entries
Samples of volunteers that never experienced episodes of uncontrollable socially debilitating odor or PATM.
|
Subjects in Regression or Remission
Individuals self-reporting remission or regression of MEBO/PATM (lessening of the severity or disappearance of the symptoms)
|
Non MEBO/PATM Cohort
individuals that never experienced MEBO/PATM episodes
|
|---|---|---|---|---|
|
Quality of Life [Score]
|
57 score on a scale
Interval 55.0 to 59.0
|
97 score on a scale
Interval 90.0 to 105.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 year after study enrollmentPopulation: 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.
The number of flareups after study enrollment
Outcome measures
| Measure |
MEBO/PATM Cohort That Submitted Gut Samples
n=154 observations
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)
|
Non-MEBO/PATM Cohort
n=34 observations
Samples of volunteers that never experienced episodes of uncontrollable socially debilitating odor or PATM.
|
Subjects in Regression or Remission
Individuals self-reporting remission or regression of MEBO/PATM (lessening of the severity or disappearance of the symptoms)
|
Non MEBO/PATM Cohort
individuals that never experienced MEBO/PATM episodes
|
|---|---|---|---|---|
|
Idiopathic Malodor Episodes
severe flareups
|
81 observations
|
7 observations
|
—
|
—
|
|
Idiopathic Malodor Episodes
moderate flareups
|
27 observations
|
12 observations
|
—
|
—
|
|
Idiopathic Malodor Episodes
remission episodes
|
6 observations
|
12 observations
|
—
|
—
|
|
Idiopathic Malodor Episodes
not sure
|
40 observations
|
3 observations
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 yearPopulation: 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.
The fecal microbial composition will be measured via taxonomic profiling using 16S ribosomal RNA gene amplicon sequencing of submitted gut samples
Outcome measures
| Measure |
MEBO/PATM Cohort That Submitted Gut Samples
n=43 samples
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)
|
Non-MEBO/PATM Cohort
n=43 samples
Samples of volunteers that never experienced episodes of uncontrollable socially debilitating odor or PATM.
|
Subjects in Regression or Remission
Individuals self-reporting remission or regression of MEBO/PATM (lessening of the severity or disappearance of the symptoms)
|
Non MEBO/PATM Cohort
individuals that never experienced MEBO/PATM episodes
|
|---|---|---|---|---|
|
Change in Fecal Microbiome Composition Between Flare-ups and Improvements
Selected dermatological bacteria, normalized counts
|
162 Normalized OTU counts in gut sample
Interval 135.0 to 502.0
|
15 Normalized OTU counts in gut sample
Interval 6.0 to 110.0
|
—
|
—
|
|
Change in Fecal Microbiome Composition Between Flare-ups and Improvements
Corynebacteriales order, normalized counts
|
302 Normalized OTU counts in gut sample
Interval 300.0 to 1148.0
|
91 Normalized OTU counts in gut sample
Interval 85.0 to 172.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 yearPopulation: 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.
Alpha (within-sample) diversity measure using microbial abundance information in a phylogenetic framework. Represented by abundance-weighted phylogenetic entropy.
Outcome measures
| Measure |
MEBO/PATM Cohort That Submitted Gut Samples
n=97 gut microbiome samples
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)
|
Non-MEBO/PATM Cohort
n=85 gut microbiome samples
Samples of volunteers that never experienced episodes of uncontrollable socially debilitating odor or PATM.
|
Subjects in Regression or Remission
n=35 gut microbiome samples
Individuals self-reporting remission or regression of MEBO/PATM (lessening of the severity or disappearance of the symptoms)
|
Non MEBO/PATM Cohort
n=16 gut microbiome samples
individuals that never experienced MEBO/PATM episodes
|
|---|---|---|---|---|
|
Alpha Diversity
|
1.7 unitless
Interval 1.6 to 1.8
|
1.6 unitless
Interval 1.0 to 2.2
|
1.7 unitless
Interval 1.6 to 1.8
|
1.9 unitless
Interval 1.8 to 2.0
|
Adverse Events
Study Participants
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place