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Gut Microbiome and Depression

NCT05808101 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 51

Last updated 2024-12-13

No results posted yet for this 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.

Conditions

Interventions

OTHER

Neuro-QoL T-score determination

Neuro-Qol depression scale, using a T-score of 55 as a threshold

Sponsors & Collaborators

  • University of Connecticut

    collaborator OTHER

  • University of Texas

    collaborator OTHER

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Laura Piccio, MD, PhD · Washington University School of Medicine

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-27
Primary Completion
2024-10-29
Completion
2024-10-29

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05808101 on ClinicalTrials.gov