N/A
N=125
Microbial Basis of Systemic Malodor and "People Allergic To Me" Conditions
Nutritional and Metabolic Diseases
Bottom Line
View on ClinicalTrials.gov: NCT03582826 ↗Enrolled (actual)
125
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Gut Microbiome — 52; 64; 25; 33 Normalized OTU counts
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Nutritional counselling (Behavioral); Stress-reduction counseling (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mebo Research, Inc.
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Gut Microbiome |
52; 64; 25; 33; 0.04; 0.35 | — |
| SECONDARY Quality of Life [Score] |
57; 97 | — |
| SECONDARY Idiopathic Malodor Episodes |
81; 7; 27; 12; 6; 12 | — |
| SECONDARY Change in Fecal Microbiome Composition Between Flare-ups and Improvements |
162; 15; 302; 91 | 0.02 sig |
| SECONDARY Alpha Diversity |
1.7; 1.6; 1.7; 1.9 | — |
Summary
The purpose of this study is to identify microbial signatures associated with remission and recurrence of idiopathic malodor and PATM conditions.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03582826). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.