Nutritional and Metabolic DiseasesPATMNCT03582826
Microbial Basis of Systemic Malodor and "People Allergic To Me" Conditions
A study testing Nutritional counselling and Stress-reduction counseling in people with Nutritional and Metabolic Diseases, run by Mebo Research, Inc. at 2 sites in 2 countries.
Trial summary
The purpose of this study is to identify microbial signatures associated with remission and recurrence of idiopathic malodor and PATM conditions. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Nutritional and Metabolic Diseases
- What is being tested?
- Nutritional counselling and Stress-reduction counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 16 Jun 2018to 10 Feb 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- idiopathic malodor or PATM symptoms experienced over a period of several months or years
- able to read and understand the study information
- willing and able to comply with questionnaires, nutritional recommendations, and other study procedures
Who cannot join
- consistent inability to communicate and process things related to their symptoms
- consistent inability to distinguish physical symptoms from pure emotional reactions
- lack of motivation to start feeling better
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Dynamics of the Gut Microbiota in Idiopathic Malodor Production
The purpose of this study is to identify microbial signatures associated with remission and recurrence of idiopathic malodor and PATM conditions.
Read the detailed description
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.
- Conditions
- Nutritional and Metabolic Diseases
- Being tested
- Nutritional counselling, Stress-reduction counseling
- Keywords
- systemic malodor, body odor, bad breath, PATM, microbiome, TMAU, Malabsorption, Dysbiosis
- Medical subject headings
- Nutritional and Metabolic Diseases, Body Odor, Halitosis, Malabsorption Syndromes, Dysbiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional counsellingBehavioural
Behavioral nutritional counselling delivered via the Internet.
Stress-reduction counselingBehavioural
The psycho-behavioral intervention includes administering questionnaires and monthly maintenance psychological support delivered via the Internet.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Nutritional counselling; Behavioral: Stress-reduction counseling |
| non-MEBO cohort | No intervention | Data volunteers that never experienced episodes of uncontrollable socially debilitating metabolic body odor (MEBO) or PATM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut Microbiome
Abundance [operational taxonomic units]
Measured: 1 year
Secondary outcomes (4)
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.
Measured: 1 year
Idiopathic Malodor Episodes
The number of flareups after study enrollment
Measured: 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
Measured: 1 year
Alpha Diversity
Alpha (within-sample) diversity measure using microbial abundance information in a phylogenetic framework. Represented by abundance-weighted phylogenetic entropy.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2018
- Study start16 Jun 2018
- Primary completion16 Jun 2019
- Study completion10 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nutritional and Metabolic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mebo Research, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- uBiome, Aurametrix
- Responsible party
- Sponsor
- Investigators
- Irene Gabashvili, PhD, Principal investigator, MeBO Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03582826
- Sponsor's protocol ID
- 201805110018MEBO
- Acronym
- PATM
- Status last verified
- Dec 2020
- First submitted
- 11 Jun 2018
- Last updated
- 5 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified patient data will be made partially available when approved by the study sponsor.
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamics of the Gut Microbiota in Idiopathic Malodor Production
- ClinicalTrials.gov ID
- NCT03582826
- Acronym / sponsor ID
- PATM / 201805110018MEBO
- Conditions
- Nutritional and Metabolic Diseases
- Keywords
- systemic malodor, body odor, bad breath, PATM, microbiome, TMAU, Malabsorption, Dysbiosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Mebo Research, Inc.University, hospital or other
- Collaborators
- uBiome, Aurametrix
- Study start
- 16 Jun 2018 (actual)
- Primary completion
- 16 Jun 2019 (actual)
- Study completion
- 10 Feb 2020 (actual)
- First posted
- 11 Jul 2018 (actual)
- Results
- Posted 5 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to identify microbial signatures associated with remission and recurrence of idiopathic malodor and PATM conditions.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MEBO/PATM cohort | Experimental | Behavioral: Nutritional counselling, Behavioral: Stress-reduction counselingNutrition 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 |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- idiopathic malodor or PATM symptoms experienced over a period of several months or years
- able to read and understand the study information
- willing and able to comply with questionnaires, nutritional recommendations, and other study procedures
Key exclusion criteria (3 listed)
- consistent inability to communicate and process things related to their symptoms
- consistent inability to distinguish physical symptoms from pure emotional reactions
- lack of motivation to start feeling better
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional counsellingBehavioral nutritional counselling delivered via the Internet. | Behavioural | MEBO/PATM cohort |
| Stress-reduction counselingThe psycho-behavioral intervention includes administering questionnaires and monthly maintenance psychological support delivered via the Internet. | Behavioural | MEBO/PATM cohort |
Primary outcome
Gut Microbiome
Time frame: 1 year
Abundance [operational taxonomic units]
4 secondary outcomes
Quality of Life [Score]
Time frame: 1 year
Idiopathic Malodor Episodes
Time frame: 1 year after study enrollment
Change in Fecal Microbiome Composition Between Flare-ups and Improvements
Time frame: 1 year
Alpha Diversity
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publicationGabashvili 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
- uBiome Awards Grant to MEBO ResearchLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Deidentified patient data will be made partially available when approved by the study sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irene Gabashvili, PhD principal investigator
MeBO Research
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional counselling and Stress-reduction counseling in people with Nutritional and Metabolic Diseases, run by Mebo Research, Inc. at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut Microbiome (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03582826, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2021.