Multiple SclerosisNCT05808101
Gut Microbiome and Depression
An observational study of Multiple Sclerosis and Depression, run by Washington University School of Medicine at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Depression
- What is being tested?
- Neuro-QoL T-score determination
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jan 2022to 29 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Multiple Sclerosis (MS)
- Age ≥18 years
- Diagnosis of RRMS or progressive MS based on the 2017 revised McDonald criteria
- Untreated or on any of the MS DMTs as long as they have been stable clinically in the previous 3 months
- No history of antibiotic treatment in the 3 months prior to study visit and sample collection
- No other autoimmune diseases, chronic metabolic diseases (e.g. diabetes) or conditions (e.g. pregnancy) that would interfere with the parameters that we will be measuring in the stool and blood samples.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University in St Louis
St Louis, Missouri, 63110
About this study
Official title: Role of the Gut Microbiome as Determinant of Depression in Multiple Sclerosis Subjects
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.
Read the detailed description
Our overall hypothesis is that specific gut microbiome or gut-derived metabolites are associated with depression in 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.
AIM 1. 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) the investigatorsight and height to calculate the BMI; 5) fatigue; 6) level of physical activity; 7) sleep quality.
AIM 1A. To determine if depression will correlate with specific gut microbiome or gut-derived metabolites profiles in pwMS.
Stool samples will be processed for microbiome sequencing and metabolome characterization.
AIM 1B. To determine if depression will correlate with a specific peripheral blood immune-inflammatory profile in pwMS.
A peripheral blood sample will be obtained from each participant to perform: 1) peripheral blood immune cell phenotyping to characterize the main immune cell subsets and their activation; 2) intracellular cytokine production to study cytokine production profiles of blood lymphocytes and monocytes.
AIM 2. To quantify GABA production in pwMS with or without depression and determine gut microbiome-immune system interaction in vitro.
In this aim the investigators will perform functional studies to evaluate the potential of gut microbiota from pwMS with or without depression to produce GABA and to modulate immune-inflammatory responses.
AIM 2A. To quantify GABA levels in whole stool, specific stool bacterial isolates and blood of pwMS with or without depression.
The investigators will evaluate GABA levels in the stool and blood of pwMS. In addition, the investigators will measure GABA production by Bacteroides ssp isolated from the gut microbiota of pwMS.
Aim 2B. To evaluate the effects of whole stool and specific bacterial species from pwMS on blood immune cell phenotype and cytokine production.
The investigators will test how whole gut microbiome or specific bacteria (identified in Aim 1 as associated with depression in pwMS) can modulate immune cell function. Peripheral blood mononuclear cells (PBMC) from healthy donors will be cultured in conditioning media from whole stool or bacteria of interest isolated from pwMS. PBMC phenotype and cytokine production after exposure in vitro will be characterized by flow cytometry.
- Conditions
- Multiple Sclerosis, Depression
- Being tested
- Neuro-QoL T-score determination
- Keywords
- Multiple Sclerosis, Depression, Microbiome
- Medical subject headings
- Multiple Sclerosis, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuro-QoL T-score determinationOther
Neuro-Qol depression scale, using a T-score of 55 as a threshold
| Study group | Role | What they receive |
|---|---|---|
| With Neuro-QoL Depression scale T-score > 55 | 1. Collection of demographic and clinical data (age, gender, BMI, ethnicity, age of onset, number of relapses).
2. Administration of the Neuro-QoL depression scale
3. Neurological exam to evaluate disability and calculate the EDSS score (ranging from 0 to 10)
4. Neurological cognitive and functional assessments: a 9-hole Peg Test and 25-ft Timed Walk from the Multiple Sclerosis Functional Composite (MSFC); the Symbol Digit Modality Test (SDMT)
5. Administration of the Fatigue Severity Scale (FSS)
6. Collection of a 4-days food diary to evaluate diet composition of enrolled pwMS
7. Administration of the Stanford 7-day Physical Activity Recall Scale (PAR)
8. Evaluation of sleep quality by administration of the Neuro-QoL sleep disturbance scale
9. Collection of a stool sample for gut microbiome and metabolome analyses
10. Collection of a saliva sample for microbiome and metabolome analyses Receives: Other: Neuro-QoL T-score determination | |
| With Neuro-QoL Depression scale T-score < 55 | 1. Collection of demographic and clinical data (age, gender, BMI, ethnicity, age of onset, number of relapses).
2. Administration of the Neuro-QoL depression scale
3. Neurological exam to evaluate disability and calculate the EDSS score (ranging from 0 to 10)
4. Neurological cognitive and functional assessments: a 9-hole Peg Test and 25-ft Timed Walk from the Multiple Sclerosis Functional Composite (MSFC); the Symbol Digit Modality Test (SDMT)
5. Administration of the Fatigue Severity Scale (FSS)
6. Collection of a 4-days food diary to evaluate diet composition of enrolled pwMS
7. Administration of the Stanford 7-day Physical Activity Recall Scale (PAR)
8. Evaluation of sleep quality by administration of the Neuro-QoL sleep disturbance scale
9. Collection of a stool sample for gut microbiome and metabolome analyses
10. Collection of a saliva sample for microbiome and metabolome analyses Receives: Other: Neuro-QoL T-score determination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 years
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.
Measured: 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2023
- Study start27 Jan 2022
- Primary completion29 Oct 2024
- Study completion29 Oct 2024
Why it stopped: Change in PI and lack of personnel available to complete futher enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (59)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of Connecticut, University of Texas
- Responsible party
- Sponsor
- Investigators
- Laura Piccio, MD, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05808101
- Sponsor's protocol ID
- 202107067
- Status last verified
- Dec 2024
- First submitted
- 17 May 2022
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Will be determined based whether or not recruitment numbers will be sufficient to power outcome analyses.
Publications
Feinstein A, Magalhaes S, Richard JF, Audet B, Moore C. The link between multiple sclerosis and depression. Nat Rev Neurol. 2014 Sep;10(9):507-17. doi: 10.1038/nrneurol.2014.139. Epub 2014 Aug 12.
PubMed 25112509Liu Y, Tang X. Depressive Syndromes in Autoimmune Disorders of the Nervous System: Prevalence, Etiology, and Influence. Front Psychiatry. 2018 Sep 25;9:451. doi: 10.3389/fpsyt.2018.00451. eCollection 2018.
PubMed 30319458Flux MC, Lowry CA. Finding intestinal fortitude: Integrating the microbiome into a holistic view of depression mechanisms, treatment, and resilience. Neurobiol Dis. 2020 Feb;135:104578. doi: 10.1016/j.nbd.2019.104578. Epub 2019 Aug 24.
PubMed 31454550Zheng P, Zeng B, Zhou C, Liu M, Fang Z, Xu X, Zeng L, Chen J, Fan S, Du X, Zhang X, Yang D, Yang Y, Meng H, Li W, Melgiri ND, Licinio J, Wei H, Xie P. Gut microbiome remodeling induces depressive-like behaviors through a pathway mediated by the host's metabolism. Mol Psychiatry. 2016 Jun;21(6):786-96. doi: 10.1038/mp.2016.44. Epub 2016 Apr 12.
PubMed 27067014Bravo JA, Forsythe P, Chew MV, Escaravage E, Savignac HM, Dinan TG, Bienenstock J, Cryan JF. Ingestion of Lactobacillus strain regulates emotional behavior and central GABA receptor expression in a mouse via the vagus nerve. Proc Natl Acad Sci U S A. 2011 Sep 20;108(38):16050-5. doi: 10.1073/pnas.1102999108. Epub 2011 Aug 29.
PubMed 21876150Wallace CJK, Milev R. The effects of probiotics on depressive symptoms in humans: a systematic review. Ann Gen Psychiatry. 2017 Feb 20;16:14. doi: 10.1186/s12991-017-0138-2. eCollection 2017.
PubMed 28239408Valles-Colomer M, Falony G, Darzi Y, Tigchelaar EF, Wang J, Tito RY, Schiweck C, Kurilshikov A, Joossens M, Wijmenga C, Claes S, Van Oudenhove L, Zhernakova A, Vieira-Silva S, Raes J. The neuroactive potential of the human gut microbiota in quality of life and depression. Nat Microbiol. 2019 Apr;4(4):623-632. doi: 10.1038/s41564-018-0337-x. Epub 2019 Feb 4.
PubMed 30718848Dethloff F, Vargas F, Elijah E, Quinn R, Park DI, Herzog DP, Muller MB, Gentry EC, Knight R, Gonzalez A, Dorrestein PC, Turck CW. Paroxetine Administration Affects Microbiota and Bile Acid Levels in Mice. Front Psychiatry. 2020 Jun 4;11:518. doi: 10.3389/fpsyt.2020.00518. eCollection 2020.
PubMed 32581888McGovern AS, Hamlin AS, Winter G. A review of the antimicrobial side of antidepressants and its putative implications on the gut microbiome. Aust N Z J Psychiatry. 2019 Dec;53(12):1151-1166. doi: 10.1177/0004867419877954. Epub 2019 Sep 26.
PubMed 31558039van den Hoogen WJ, Laman JD, 't Hart BA. Modulation of Multiple Sclerosis and Its Animal Model Experimental Autoimmune Encephalomyelitis by Food and Gut Microbiota. Front Immunol. 2017 Sep 5;8:1081. doi: 10.3389/fimmu.2017.01081. eCollection 2017.
PubMed 28928747Cantarel BL, Waubant E, Chehoud C, Kuczynski J, DeSantis TZ, Warrington J, Venkatesan A, Fraser CM, Mowry EM. Gut microbiota in multiple sclerosis: possible influence of immunomodulators. J Investig Med. 2015 Jun;63(5):729-34. doi: 10.1097/JIM.0000000000000192.
PubMed 25775034Berer K, Gerdes LA, Cekanaviciute E, Jia X, Xiao L, Xia Z, Liu C, Klotz L, Stauffer U, Baranzini SE, Kumpfel T, Hohlfeld R, Krishnamoorthy G, Wekerle H. Gut microbiota from multiple sclerosis patients enables spontaneous autoimmune encephalomyelitis in mice. Proc Natl Acad Sci U S A. 2017 Oct 3;114(40):10719-10724. doi: 10.1073/pnas.1711233114. Epub 2017 Sep 11.
PubMed 28893994Cekanaviciute E, Yoo BB, Runia TF, Debelius JW, Singh S, Nelson CA, Kanner R, Bencosme Y, Lee YK, Hauser SL, Crabtree-Hartman E, Sand IK, Gacias M, Zhu Y, Casaccia P, Cree BAC, Knight R, Mazmanian SK, Baranzini SE. Gut bacteria from multiple sclerosis patients modulate human T cells and exacerbate symptoms in mouse models. Proc Natl Acad Sci U S A. 2017 Oct 3;114(40):10713-10718. doi: 10.1073/pnas.1711235114. Epub 2017 Sep 11.
PubMed 28893978Jangi S, Gandhi R, Cox LM, Li N, von Glehn F, Yan R, Patel B, Mazzola MA, Liu S, Glanz BL, Cook S, Tankou S, Stuart F, Melo K, Nejad P, Smith K, Topcuolu BD, Holden J, Kivisakk P, Chitnis T, De Jager PL, Quintana FJ, Gerber GK, Bry L, Weiner HL. Alterations of the human gut microbiome in multiple sclerosis. Nat Commun. 2016 Jun 28;7:12015. doi: 10.1038/ncomms12015.
PubMed 27352007Dinan TG, Cryan JF. Gut instincts: microbiota as a key regulator of brain development, ageing and neurodegeneration. J Physiol. 2017 Jan 15;595(2):489-503. doi: 10.1113/JP273106. Epub 2016 Dec 4.
PubMed 27641441
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of the Gut Microbiome as Determinant of Depression in Multiple Sclerosis Subjects
- ClinicalTrials.gov ID
- NCT05808101
- Acronym / sponsor ID
- 202107067
- Conditions
- Multiple Sclerosis, Depression
- Keywords
- Multiple Sclerosis, Depression, Microbiome
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Change in PI and lack of personnel available to complete futher enrollment
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- University of Connecticut, University of Texas
- Study start
- 27 Jan 2022 (actual)
- Primary completion
- 29 Oct 2024 (actual)
- Study completion
- 29 Oct 2024 (actual)
- First posted
- 11 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Our overall hypothesis is that specific gut microbiome or gut-derived metabolites are associated with depression in 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.
AIM 1. 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) the investigatorsight and height to calculate the BMI; 5) fatigue; 6) level of physical activity; 7) sleep quality.
AIM 1A. To determine if depression will correlate with specific gut microbiome or gut-derived metabolites profiles in pwMS.
Stool samples will be processed for microbiome sequencing and metabolome characterization.
AIM 1B. To determine if depression will correlate with a specific peripheral blood immune-inflammatory profile in pwMS.
A peripheral blood sample will be obtained from each participant to perform: 1) peripheral blood immune cell phenotyping to characterize the main immune cell subsets and their activation; 2) intracellular cytokine production to study cytokine production profiles of blood lymphocytes and monocytes.
AIM 2. To quantify GABA production in pwMS with or without depression and determine gut microbiome-immune system interaction in vitro.
In this aim the investigators will perform functional studies to evaluate the potential of gut microbiota from pwMS with or without depression to produce GABA and to modulate immune-inflammatory responses.
AIM 2A. To quantify GABA levels in whole stool, specific stool bacterial isolates and blood of pwMS with or without depression.
The investigators will evaluate GABA levels in the stool and blood of pwMS. In addition, the investigators will measure GABA production by Bacteroides ssp isolated from the gut microbiota of pwMS.
Aim 2B. To evaluate the effects of whole stool and specific bacterial species from pwMS on blood immune cell phenotype and cytokine production.
The investigators will test how whole gut microbiome or specific bacteria (identified in Aim 1 as associated with depression in pwMS) can modulate immune cell function. Peripheral blood mononuclear cells (PBMC) from healthy donors will be cultured in conditioning media from whole stool or bacteria of interest isolated from pwMS. PBMC phenotype and cytokine production after exposure in vitro will be characterized by flow cytometry.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With Neuro-QoL Depression scale T-score > 55 | – | Other: Neuro-QoL T-score determination1. Collection of demographic and clinical data (age, gender, BMI, ethnicity, age of onset, number of relapses). 2. Administration of the Neuro-QoL depression scale 3. Neurological exam to evaluate disability and calculate the EDSS score (ranging from 0 to 10) 4. Neurological cognitive and functional assessments: a 9-hole Peg Test and 25-ft Timed Walk from the Multiple Sclerosis Functional Composite (MSFC); the Symbol Digit Modality Test (SDMT) 5. Administration of the Fatigue Severity Scale (FSS) 6. Collection of a 4-days food diary to evaluate diet composition of enrolled pwMS 7. Administration of the Stanford 7-day Physical Activity Recall Scale (PAR) 8. Evaluation of sleep quality by administration of the Neuro-QoL sleep disturbance scale 9. Collection of a stool sample for gut microbiome and metabolome analyses 10. Collection of a saliva sample for microbiome and metabolome analyses |
| With Neuro-QoL Depression scale T-score < 55 | – | Other: Neuro-QoL T-score determination1. Collection of demographic and clinical data (age, gender, BMI, ethnicity, age of onset, number of relapses). 2. Administration of the Neuro-QoL depression scale 3. Neurological exam to evaluate disability and calculate the EDSS score (ranging from 0 to 10) 4. Neurological cognitive and functional assessments: a 9-hole Peg Test and 25-ft Timed Walk from the Multiple Sclerosis Functional Composite (MSFC); the Symbol Digit Modality Test (SDMT) 5. Administration of the Fatigue Severity Scale (FSS) 6. Collection of a 4-days food diary to evaluate diet composition of enrolled pwMS 7. Administration of the Stanford 7-day Physical Activity Recall Scale (PAR) 8. Evaluation of sleep quality by administration of the Neuro-QoL sleep disturbance scale 9. Collection of a stool sample for gut microbiome and metabolome analyses 10. Collection of a saliva sample for microbiome and metabolome analyses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Multiple Sclerosis (MS)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuro-QoL T-score determinationNeuro-Qol depression scale, using a T-score of 55 as a threshold | Other | With Neuro-QoL Depression scale T-score < 55, With Neuro-QoL Depression scale T-score > 55 |
Primary outcome
Gut microbiome, gut-derived metabolites and peripheral blood immune profiles
Time frame: 3 years
Gut microbiome will be characterized by metagenomic sequencing. Untargeted metabolome analysis performed by LC-MS. Peripheral blood phenotyping performed by flow cytometry analysis
GABA levels in whole stool, specific stool bacteria isolates and blood
Time frame: 3 Years
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.
Results and safety
The study was stopped early (reason given: Change in PI and lack of personnel available to complete futher enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Background: PubMed 25112509Feinstein A, Magalhaes S, Richard JF, Audet B, Moore C. The link between multiple sclerosis and depression. Nat Rev Neurol. 2014 Sep;10(9):507-17. doi: 10.1038/nrneurol.2014.139. Epub 2014 Aug 12.
- Background: PubMed 30319458Liu Y, Tang X. Depressive Syndromes in Autoimmune Disorders of the Nervous System: Prevalence, Etiology, and Influence. Front Psychiatry. 2018 Sep 25;9:451. doi: 10.3389/fpsyt.2018.00451. eCollection 2018.
- Background: PubMed 31454550Flux MC, Lowry CA. Finding intestinal fortitude: Integrating the microbiome into a holistic view of depression mechanisms, treatment, and resilience. Neurobiol Dis. 2020 Feb;135:104578. doi: 10.1016/j.nbd.2019.104578. Epub 2019 Aug 24.
- Background: PubMed 27067014Zheng P, Zeng B, Zhou C, Liu M, Fang Z, Xu X, Zeng L, Chen J, Fan S, Du X, Zhang X, Yang D, Yang Y, Meng H, Li W, Melgiri ND, Licinio J, Wei H, Xie P. Gut microbiome remodeling induces depressive-like behaviors through a pathway mediated by the host's metabolism. Mol Psychiatry. 2016 Jun;21(6):786-96. doi: 10.1038/mp.2016.44. Epub 2016 Apr 12.
- Background: PubMed 21876150Bravo JA, Forsythe P, Chew MV, Escaravage E, Savignac HM, Dinan TG, Bienenstock J, Cryan JF. Ingestion of Lactobacillus strain regulates emotional behavior and central GABA receptor expression in a mouse via the vagus nerve. Proc Natl Acad Sci U S A. 2011 Sep 20;108(38):16050-5. doi: 10.1073/pnas.1102999108. Epub 2011 Aug 29.
- Background: PubMed 28239408Wallace CJK, Milev R. The effects of probiotics on depressive symptoms in humans: a systematic review. Ann Gen Psychiatry. 2017 Feb 20;16:14. doi: 10.1186/s12991-017-0138-2. eCollection 2017.
- Background: PubMed 30718848Valles-Colomer M, Falony G, Darzi Y, Tigchelaar EF, Wang J, Tito RY, Schiweck C, Kurilshikov A, Joossens M, Wijmenga C, Claes S, Van Oudenhove L, Zhernakova A, Vieira-Silva S, Raes J. The neuroactive potential of the human gut microbiota in quality of life and depression. Nat Microbiol. 2019 Apr;4(4):623-632. doi: 10.1038/s41564-018-0337-x. Epub 2019 Feb 4.
- Background: PubMed 32581888Dethloff F, Vargas F, Elijah E, Quinn R, Park DI, Herzog DP, Muller MB, Gentry EC, Knight R, Gonzalez A, Dorrestein PC, Turck CW. Paroxetine Administration Affects Microbiota and Bile Acid Levels in Mice. Front Psychiatry. 2020 Jun 4;11:518. doi: 10.3389/fpsyt.2020.00518. eCollection 2020.
- Background: PubMed 31558039McGovern AS, Hamlin AS, Winter G. A review of the antimicrobial side of antidepressants and its putative implications on the gut microbiome. Aust N Z J Psychiatry. 2019 Dec;53(12):1151-1166. doi: 10.1177/0004867419877954. Epub 2019 Sep 26.
- Background: PubMed 28928747van den Hoogen WJ, Laman JD, 't Hart BA. Modulation of Multiple Sclerosis and Its Animal Model Experimental Autoimmune Encephalomyelitis by Food and Gut Microbiota. Front Immunol. 2017 Sep 5;8:1081. doi: 10.3389/fimmu.2017.01081. eCollection 2017.
- Background: PubMed 25775034Cantarel BL, Waubant E, Chehoud C, Kuczynski J, DeSantis TZ, Warrington J, Venkatesan A, Fraser CM, Mowry EM. Gut microbiota in multiple sclerosis: possible influence of immunomodulators. J Investig Med. 2015 Jun;63(5):729-34. doi: 10.1097/JIM.0000000000000192.
- Background: PubMed 28893994Berer K, Gerdes LA, Cekanaviciute E, Jia X, Xiao L, Xia Z, Liu C, Klotz L, Stauffer U, Baranzini SE, Kumpfel T, Hohlfeld R, Krishnamoorthy G, Wekerle H. Gut microbiota from multiple sclerosis patients enables spontaneous autoimmune encephalomyelitis in mice. Proc Natl Acad Sci U S A. 2017 Oct 3;114(40):10719-10724. doi: 10.1073/pnas.1711233114. Epub 2017 Sep 11.
- Individual participant dataSharing planned: Undecided. Will be determined based whether or not recruitment numbers will be sufficient to power outcome analyses.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Piccio, MD, PhD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis and Depression, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Change in PI and lack of personnel available to complete futher enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut microbiome, gut-derived metabolites and peripheral blood immune profiles (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05808101, which also lists 59 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2024.