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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05808101
Other study ID # 202107067
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 27, 2022
Est. completion date October 2024

Study information

Verified date March 2023
Source Washington University School of Medicine
Contact Laura Piccio, MD,PhD
Phone 314-747-4591
Email picciol@wustl.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

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Study Design


Intervention

Other:
Neuro-QoL T-score determination
Neuro-Qol depression scale, using a T-score of 55 as a threshold

Locations

Country Name City State
United States Washington University in St Louis Saint Louis Missouri

Sponsors (3)

Lead Sponsor Collaborator
Washington University School of Medicine University of Connecticut, University of Texas

Country where clinical trial is conducted

United States, 

References & Publications (59)

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Outcome

Type Measure Description Time frame Safety issue
Primary Gut microbiome, gut-derived metabolites and peripheral blood immune profiles Gut microbiome will be characterized by metagenomic sequencing. Untargeted metabolome analysis performed by LC-MS. Peripheral blood phenotyping performed by flow cytometry analysis 3 years
Primary GABA levels in whole stool, specific stool bacteria isolates and blood GABA levels in whole stool measured by targeted LC-MS Effects of whole stool and specific bacterial species from people with MS with or without depression on blood immune cell phenotype and cytokine production measured by flow cytometry. 3 Years
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