An interventional study of Nutritional counselling and Stress-reduction counseling in Nutritional and Metabolic Diseases, sponsored by Mebo Research, Inc.. Completed at 2 sites in 2 countries. Open to participants aged 18 Years to 110 Years. Per ClinicalTrials.gov, last updated 2021-01-05.
Sponsored by Mebo Research, Inc. · Not applicable, Interventional, and Supportive care
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.
Exclusion Criteria:
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.
Behavioral: Nutritional counselling · Behavioral: Stress-reduction counseling
Data volunteers that never experienced episodes of uncontrollable socially debilitating metabolic body odor (MEBO) or PATM
Behavioral nutritional counselling delivered via the Internet.
The psycho-behavioral intervention includes administering questionnaires and monthly maintenance psychological support delivered via the Internet.
Gut Microbiome
Abundance \[operational taxonomic units\]
Time frame: 1 year
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.
Time frame: 1 year
Idiopathic Malodor Episodes
The number of flareups after study enrollment
Time frame: 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
Time frame: 1 year
Alpha Diversity
Alpha (within-sample) diversity measure using microbial abundance information in a phylogenetic framework. Represented by abundance-weighted phylogenetic entropy.
Time frame: 1 year
| Milestone | MEBO/PATM Cohort | Non-MEBO/PATM Cohort |
|---|---|---|
| Started | 119 | 6 |
| Completed | 78 | 6 |
| Not completed | 41 | 0 |
| Withdrew: Lost to follow-up | 39 | 0 |
| Withdrew: Withdrawal by subject | 2 | 0 |
Abundance \[operational taxonomic units\]
| Normalized OTU counts | MEBO/PATM Cohort That Submitted Gut Samples | Non-MEBO/PATM Cohort |
|---|---|---|
| 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) |
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.
| score on a scale | Subjects With Active MEBO/PATM | Subjects in Regression or Remission |
|---|---|---|
| Quality of Life [Score] | 57 (55 to 59) | 97 (90 to 105) |
The number of flareups after study enrollment
| observations | Subjects With Active MEBO/PATM | Subjects in Regression or Remission |
|---|---|---|
| severe flareups | 81 | 7 |
| moderate flareups | 27 | 12 |
| remission episodes | 6 | 12 |
| not sure | 40 | 3 |
The fecal microbial composition will be measured via taxonomic profiling using 16S ribosomal RNA gene amplicon sequencing of submitted gut samples
| Normalized OTU counts in gut sample | MEBO/PATM Subcohort After Flare-up | MEBO/PATM Subcohort After Improvement |
|---|---|---|
| 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) |
Alpha (within-sample) diversity measure using microbial abundance information in a phylogenetic framework. Represented by abundance-weighted phylogenetic entropy.
| unitless | Subjects With Active MEBO | Subjects With Active PATM | Subjects in Regression or Remission | Non MEBO/PATM Cohort |
|---|---|---|---|---|
| Alpha Diversity | 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) |
Collected over participants were observed for one year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Study Participants | 0/125 (0%) | 0/125 (0%) | 0/125 (0%) |
Participants at Baseline who consented to submit their data
| Age, Continuous(years) | MEBO/PATM Cohort | Non-MEBO/PATM Cohort | Total |
|---|---|---|---|
| Mean | 40 ± 12 | 40 ± 20 | 40 ± 13 |
| Sex: Female, Male(Participants) | MEBO/PATM Cohort | Non-MEBO/PATM Cohort | Total |
|---|---|---|---|
| Female | 79 | 1 | 80 |
| Male | 40 | 5 | 45 |
| Race and Ethnicity Not Collected(Participants) | MEBO/PATM Cohort | Non-MEBO/PATM Cohort | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | MEBO/PATM Cohort | Non-MEBO/PATM Cohort | Total |
|---|---|---|---|
| United States | 70 | 5 | 75 |
| United Kingdom | 10 | 0 | 10 |
| Argentina | 4 | 0 | 4 |
| Brazil | 4 | 0 | 4 |
| Burkina Faso | 1 | 0 | 1 |
| Canada | 5 | 0 | 5 |
| Colombia | 1 | 0 | 1 |
| France | 1 | 0 | 1 |
| Hong Kong | 2 | 0 | 2 |
| Italy | 1 | 0 | 1 |
| Kenya | 2 | 0 | 2 |
| Mexico | 1 | 0 | 1 |
| Morocco | 1 | 0 | 1 |
| Netherlands | 1 | 0 | 1 |
| Nigeria | 3 | 0 | 3 |
| Pakistan | 1 | 0 | 1 |
| Peru | 2 | 0 | 2 |
| Philippines | 1 | 0 | 1 |
| Portugal | 1 | 0 | 1 |
| South Africa | 1 | 0 | 1 |
| Spain | 5 | 1 | 6 |
| Sweden | 1 | 0 | 1 |
| TMAU status(Participants) | MEBO/PATM Cohort | Non-MEBO/PATM Cohort | Total |
|---|---|---|---|
| Primary TMAU | 23 | 0 | 23 |
| Secondary TMAU | 12 | 0 | 12 |
| Negative TMAU test result | 26 | 0 | 26 |
| Not tested for TMAU | 58 | 6 | 64 |
| PATM status(Participants) | MEBO/PATM Cohort | Non-MEBO/PATM Cohort | Total |
|---|---|---|---|
| PATM with or without MEBO | 60 | 0 | 60 |
| MEBO | 59 | 0 | 59 |
| neither MEBO nor PATM | 0 | 6 | 6 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Deidentified patient data will be made partially available when approved by the study sponsor.
Supporting information: Study protocol, Icf
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Mebo Research, Inc.