Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06451588
Status:
RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-06-04
Brief Title:
Fecal Microbiota Transplantation in Axial Spondyloarthritis
Sponsor:
University Hospital of North Norway
Organization:
University Hospital of North Norway
Study Overview
Official Title:
Donor Versus Autologous Fecal Microbiota Transplantation for Axial Spondyloarthritis a Double Blind Placebo-Controlled Randomized Trial
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MicroSpA
Brief Summary:
Although biologic therapy have revolutionized the treatment of Spondyloarthrtitis SpA many patients do not experience complete relief of SpA related complaints
It has been established that patients with SpA have an altered composition of microorganisms microbiota in the gut compared to healthy controls and that this correlates to disease activity and respons to therapy
The goal of this randomized double-blind study is to evaluate the efficacy of fecal microbiota transplantation FMT in patients with axial SpA with a suboptimal effect of biologic therapy
The main questions it aims to answer are
Can FMT reduce disease activity in axial SpA
Can FMT alleviate pain and reduce fatigue in axial SpA
Is the composition of microorganisms restored to normal in patients with SpA after a treatment with FMT
Participants will receive a single treatment in the form of an enema with either donor FMT or placebo at baseline The primary endpoint will be evaluated after 90 days but efficacy and safety will be monitored from baseline until 365 days
It has been established that patients with SpA have an altered composition of microorganisms microbiota in the gut compared to healthy controls and that this correlates to disease activity and respons to therapy
The goal of this randomized double-blind study is to evaluate the efficacy of fecal microbiota transplantation FMT in patients with axial SpA with a suboptimal effect of biologic therapy
The main questions it aims to answer are
Can FMT reduce disease activity in axial SpA
Can FMT alleviate pain and reduce fatigue in axial SpA
Is the composition of microorganisms restored to normal in patients with SpA after a treatment with FMT
Participants will receive a single treatment in the form of an enema with either donor FMT or placebo at baseline The primary endpoint will be evaluated after 90 days but efficacy and safety will be monitored from baseline until 365 days
Detailed Description:
Axial Spondyloarthritis axSpA is a chronic inflammatory disease affecting the sacroiliac joints SIJ and the spine
The approach to treatment of axSpA is a combination of patient education with a focus on exercise and lifestyle and a medical treatment Non-steroidal anti-inflammatory drugs NSAIDs are the first-line medical treatment providing symptom relief for a large portion of the patients For patients with inadequate response or intolerance to NSAIDs biological TNFi and IL17i or targeted synthetic JAKi disease modifying drugs bts-DMARDs are considered a second-line treatment option and provide excellent efficacy for many patients However a substantial portion of the patients experience active disease despite this second-line therapy
The cause of the disease is multifactorial and both genetic and environmental factors contribute in the pathogenesis Patients with axSpA have a higher prevalence of inflammatory bowel disease IBD than the background population ie Crohns disease and ulcerative colitis However inflammation in the gut is also demonstrated in 50-70 of patients without symptoms of IBD and this inflammation is believed to be of importance in the development of the disease
The human gut microbiota is the collection of microbes in the intestines The composition of the microbiota is the result of many factors and have evolved over time to form a mutually beneficial relationship to both humans and microorganisms Normally there is a balance and a stability in this composition but in many conditions an imbalance termed dysbiosis has been demonstrated This is also the case in axSpA and the extent of this dysbiosis also relates to disease activity and to response to therapy
Fecal microbiota transplantation FMT is a method used to alter the microbiota composition by transferring microbes from a healthy individual to a recipient In several conditions this has both proven the ability to alter the microbiota and to provide symptom relief eg clostridium difficile infections ulcerative colitis and irritable bowel syndrome
Given the potential role of the microbiota in the pathogenesis of axSpA we wish to evaluate whether replacing the microbiota in patients with inadequate response to biologic therapy with FMT can be efficacious in providing a state of inactive disease and symptom relief
The approach to treatment of axSpA is a combination of patient education with a focus on exercise and lifestyle and a medical treatment Non-steroidal anti-inflammatory drugs NSAIDs are the first-line medical treatment providing symptom relief for a large portion of the patients For patients with inadequate response or intolerance to NSAIDs biological TNFi and IL17i or targeted synthetic JAKi disease modifying drugs bts-DMARDs are considered a second-line treatment option and provide excellent efficacy for many patients However a substantial portion of the patients experience active disease despite this second-line therapy
The cause of the disease is multifactorial and both genetic and environmental factors contribute in the pathogenesis Patients with axSpA have a higher prevalence of inflammatory bowel disease IBD than the background population ie Crohns disease and ulcerative colitis However inflammation in the gut is also demonstrated in 50-70 of patients without symptoms of IBD and this inflammation is believed to be of importance in the development of the disease
The human gut microbiota is the collection of microbes in the intestines The composition of the microbiota is the result of many factors and have evolved over time to form a mutually beneficial relationship to both humans and microorganisms Normally there is a balance and a stability in this composition but in many conditions an imbalance termed dysbiosis has been demonstrated This is also the case in axSpA and the extent of this dysbiosis also relates to disease activity and to response to therapy
Fecal microbiota transplantation FMT is a method used to alter the microbiota composition by transferring microbes from a healthy individual to a recipient In several conditions this has both proven the ability to alter the microbiota and to provide symptom relief eg clostridium difficile infections ulcerative colitis and irritable bowel syndrome
Given the potential role of the microbiota in the pathogenesis of axSpA we wish to evaluate whether replacing the microbiota in patients with inadequate response to biologic therapy with FMT can be efficacious in providing a state of inactive disease and symptom relief
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None