NCT05746845|Completed
Implication of 5-HT7 Receptor in Inflammatory Mechanisms in Multiple Sclerosis
RESEPTOR 5-HT7
RESEPTOR 5-HT7 : Interest of the 5-HT7 Serotonin Receptor as a Biomarker in Multiple Sclerosis
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RESEPTOR 5-HT7
RESEPTOR 5-HT7 : Interest of the 5-HT7 Serotonin Receptor as a Biomarker in Multiple Sclerosis
Sponsor study identifier
observational
100
1 country
1
Study Start
March 6, 2023
Actual (reported)Primary Completion
July 1, 2024
Actual (reported)Study Completion
July 1, 2024
Actual (reported)Multiple Sclerosis is a chronic autoimmune disease associated with inflammatory response harmful for the Central Nervous System. Immunological imbalance is involved with Th1 and Th17 cells in correlation with a disturbance of regulators mechanisms as Treg cells. Despite years of research, the mechanisms involved remain unclear. Serotonin (5-HT) seems to be play an essential role in developing CNS inflammatory diseases and in particular in MS. Indeed, several studies have shown the anti-inflammatory potential of this neurotransmitter and also its vulnerability in inflammatory context. Moreover, a recent study has shown that 5-HT can reduced CD4 T cells proliferation and pro-inflammatory cytokines released in vitro. Interestingly, treatment, treatment with SSRIs (selective serotonin reuptake inhibitor) in an animal model of MS, on Experimental Autoimmune Encephalomyelitis, was shown to improve the clinical score and promote remission of the disease. Among serotonin receptors, the 5-HT7 receptor, can be considered as an interesting target to treat neurological disorders associated with inflammatory context. Present in humans and mice, this receptor is expressed on the surface of a large number of cells, such as T-lymphocytes, macrophages, dendritic cells as well as on cells of CNS such as neurons, astrocytes and microglia. Given the importance of the positive cells for 5-HT7 receptor, in the inflammatory context observed in multiple sclerosis, the investigators propose to study the receptor expression in blood samples from multiple sclerosis patient.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 1, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 25, 2023
Actual (reported)February 28, 2023
Actual (reported)March 6, 2023
Actual (reported)July 1, 2024
Actual (reported)July 1, 2024
Actual (reported)5-HT7 receptor expression on circulating cells
using the flow cytometry technique, on whole blood, we will perform immunophenotyping in order to determine the fluorescence intensity of cells positive for the receptor (5-HT7+ cells) (B, T and NK lymphocytes, monocytes, and polynuclear cells) in the different groups of individuals.
Day 1
Expression of the 5-HT7 receptor after positive selection of different cell populations from PBMC
Day 15
Expression of the different isoforms of the 5-HT7 receptor on PBMC
Day 15
Functional activity of the 5-HT7 receptor on PBMC: protein studies
Day 15
Functional activity of the 5-HT7 receptor on PBMC: mRNA expression studies
Day 15
Relationship between Multiple sclerosis treatment on inflammation and serotonin production in serum
Day 15
Group 1: Healthy individuals, so-called "control" donors whose blood samples will be collected from the EFS (French Blood Establishment)
Group 2: Stable MS patients without inflammatory activity of the disease treated with high efficacy treatment (Natalizumab or Ocrelizumab)
Group 3: Stable MS patients without inflammatory disease activity treated with moderately effective treatment (Teriflunomide or Fumarate)
Blood sampling will be done on three groups: Group 1: Healthy volunteers, so-called "control" donors whose blood samples will be ordered from the EFS (French Blood Establishment) Group 2: Stable MS patients without inflammatory activity of the disease treated with high efficacy treatment (Natalizumab or Ocrelizumab) Group 3: Stable MS patients without inflammatory disease activity treated with moderately effective treatment (Teriflunomide or Fumarate)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Group 1: Healthy individuals, so-called "control" donors whose blood samples will be collected from the EFS (French Blood Establishment) Group 2: Stable MS patients without inflammatory activity of the disease under high efficacy treatment (Natalizumab or Ocrelizumab) Group 3: Stable MS patients without inflammatory disease activity under moderately effective treatment (Teriflunomide or Fumarate)
CHU Orléans
Orléans, 45067, France
Sacramento PM, Monteiro C, Dias ASO, Kasahara TM, Ferreira TB, Hygino J, Wing AC, Andrade RM, Rueda F, Sales MC, Vasconcelos CC, Bento CAM. Serotonin decreases the production of Th1/Th17 cytokines and elevates the frequency of regulatory CD4+ T-cell subsets in multiple sclerosis patients. Eur J Immunol. 2018 Aug;48(8):1376-1388. doi: 10.1002/eji.201847525. Epub 2018 Jun 6.
Yuan XQ, Qiu G, Liu XJ, Liu S, Wu Y, Wang X, Lu T. Fluoxetine promotes remission in acute experimental autoimmune encephalomyelitis in rats. Neuroimmunomodulation. 2012;19(4):201-8. doi: 10.1159/000334095. Epub 2012 Mar 21.
Maud PALLIX-GUYOT, Dr
CHU Orleans
100 participants (actual enrollment reported by the registry).
First Submitted
January 25, 2023
First Posted
February 28, 2023
Study Start
March 6, 2023
Actual (reported)The Role of Incretins in Bone Remodeling in Humans
Contact the study team to confirm eligibility.
Primary Completion
July 1, 2024
Actual (reported)Study Completion
July 1, 2024
Actual (reported)Last Updated
December 23, 2025
Record last verified: 2025-12
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