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NCT05808101 · ClinicalTrials.gov registry record
Gut Microbiome and Depression
A clinical trial, sponsored by Washington University School of Medicine.
- Terminated
- Registry status
- 51
- Enrollment target
NCT05808101: Clinical Trial study, sponsored by Washington University School of Medicine.
NCT05808101 is a clinical trial that was terminated before completion, run by Washington University School of Medicine. The registered enrollment target is 51 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05808101 was terminated before completion, sponsored by Washington University School of Medicine.
- TERMINATED
- Registry status
- 51 participants
- Enrollment target
Study Summary
The purpose of this project is to determine if specific gut microbiome or gut-derived metabolites are associated with depression in patients with Multiple Sclerosis (pwMS). Mechanistically, the investigators further hypothesize that depression in pwMS is related to decreased abundance of gut bacteria with GABA-producing activities and/or with anti-inflammatory properties. To determine if the presence of depression in pwMS is associated with specific gut microbiome, gut-derived metabolites or peripheral blood immune profiles. The investigators will perform a cross-sectional study in clinically stable pwMS recruited at the John L. Trotter MS Center. The investigators will evaluate the presence of depression using the Quality of Life in Neurological Disorders (Neuro-Qol) depression scale, one of the 13 scales in the Neuro-Qol recently developed by the NIH using modern psychometric techniques and validated in pwMS. A total of 120 pwMS will be recruited: 60 with and 60 without depression based on the Neuro-Qol depression scale. At the study visit each participant will be asked to provide a stool sample for microbiome analyses and a blood sample for peripheral blood immunophenotyping. Potential confounders will be collected and treated as covariates in the analyses. These include: 1) degree of disability (EDSS); 2) treatment with anti-depressants and DMTs; 3) a 4-days food diary to evaluate diet composition; 4) weight and height to calculate the BMI; 5) fatigue; 6) level of physical activity; 7) sleep quality.
Primary Outcome
Gut microbiome will be characterized by metagenomic sequencing. Untargeted metabolome analysis performed by LC-MS. Peripheral blood phenotyping performed by flow cytometry analysis
Interventions
- OTHER Neuro-QoL T-score determination
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2022-01-27 |
| Est. Completion | 2024-10-29 |
Why NCT05808101 stopped before completion
NCT05808101 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 51 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Neuro-QoL T-score determination is the first listed.
NCT05808101 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05808101 about?
NCT05808101 is a clinical study titled "Gut Microbiome and Depression". The purpose of this project is to determine if specific gut microbiome or gut-derived metabolites are associated with depression in patients with Multiple Sclerosis (pwMS). Mechanistically, the investigators further hypothesize that depression in pwMS is related to decreased abundance of gut bacteri...
What is the current status of trial NCT05808101?
This trial is currently terminated. The enrollment target is 51 participants. The study started on 2022-01-27. Estimated completion is 2024-10-29.
What interventions are being tested in trial NCT05808101?
The interventions under investigation include: Neuro-QoL T-score determination (OTHER).
Who is sponsoring clinical trial NCT05808101?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
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