Nutritional counselling
BehavioralBehavioral nutritional counselling delivered via the Internet.
NCT Number: NCT03582826
The purpose of this study is to identify microbial signatures associated with remission and recurrence of idiopathic malodor and PATM conditions.
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Notify Me18 year–110 year
All sexes
Interventional
Not applicable
MeBO Research LTD, London, England, United Kingdom
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Behavioral nutritional counselling delivered via the Internet.
The psycho-behavioral intervention includes administering questionnaires and monthly maintenance psychological support delivered via the Internet.
Time frame: 1 year
Abundance [operational taxonomic units]
Time frame: 1 year
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 after study enrollment
The number of flareups after study enrollment
Time frame: 1 year
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 (within-sample) diversity measure using microbial abundance information in a phylogenetic framework. Represented by abundance-weighted phylogenetic entropy.
Mebo Research, Inc.
Other
Dynamics of the Gut Microbiota in Idiopathic Malodor Production
Acronym: PATM
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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