Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06504784
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-06-11
Brief Title:
The Role of Gut Bacteria in the Immune Response to Vaccination in Patients With Ulcerative Colitis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of Dietary Fiber on Gut Microbiota Composition and Immune Response to Influenza Vaccination in Ulcerative Colitis Patients on Immunosuppressive Therapy A Randomized Double-blind Placebo-controlled Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients with the inflammatory bowel disease ulcerative colitis UC are a high-risk group encouraged to get vaccinated against seasonal influenza It is also known that UC patients may have an altered gut microbiota
Patients with more severe disease are treated with immunosuppressive medications such as thiopurines and biologics that block pro-inflammatory cytokines However these treatments makes patients more susceptible to infections and results in a poorer response to certain types of vaccinations as the immunosuppressive treatment aims to suppress mechanisms in the immune response
The purpose of the study is to determine if dietary fibers can improve the immune response to influenza vaccination in UC patients treated with immunosuppressive medications Further the study aims to determine if dietary fibers prebiotics can enrich the composition and function of the gut microbiota in UC patients
Patients with more severe disease are treated with immunosuppressive medications such as thiopurines and biologics that block pro-inflammatory cytokines However these treatments makes patients more susceptible to infections and results in a poorer response to certain types of vaccinations as the immunosuppressive treatment aims to suppress mechanisms in the immune response
The purpose of the study is to determine if dietary fibers can improve the immune response to influenza vaccination in UC patients treated with immunosuppressive medications Further the study aims to determine if dietary fibers prebiotics can enrich the composition and function of the gut microbiota in UC patients
Detailed Description:
Project Description
The purpose of the study is to determine if dietary fibers can improve the immune response to influenza vaccination in UC patients treated with immunosuppressive medications The investigators also intend to determine if dietary fibers prebiotics can enrich the composition and function of the gut microbiota in UC patients
Background and Justification
Patients with moderate to severe UC often require lifelong medical treatment Long-term treatment typically includes medications such as 5-ASA immunomodulatory agents like thiopurines andor antibodies or biologics that block pro-inflammatory cytokines These medical treatments aim to suppress the patients inflammatory activity both systemically and locally in the gut The treatment is often effective leading to complete or partial healing of gut inflammation known as remission Unfortunately the treatment also makes patients more susceptible to infections and results in a poorer response to certain types of vaccinations
Patients with UC are a high-risk group and are encouraged to vaccinate against the seasonal influenza virus Vaccination activates immune cells to produce antibodies that protect against the influenza virus The effectiveness of the vaccination is measured by the levels titers of influenza-specific antibodies formed Previous studies have shown that patients treated with biologics such as antibodies against the pro-inflammatory cytokine TNF have a poorer response to various vaccinations including influenza and therefore receive less protection against the infection
Recent studies have shown that the composition of the gut microbiota at the time of vaccination affects the responseprotection from vaccination in healthy volunteers The studies also implicate research subjects with a poorermore depleted composition of gut bacteria with a reduced ability to form antibodies and thus create immunological protection in response to vaccination It is known that UC patients have a depleted composition of gut bacteria compared to healthy individuals
Previous studies have suggested that it may be possible to improve the composition of gut bacteria in UC patients by enriching the diet with dietary fibers known as prebiotics which promote the presence of certain gut bacteria believed to have health-promoting effects There are many different types of dietary fibers consisting of carbohydrates and starch Examples of dietary fibers include inulin mannose galacto-oligosaccharides and starch
Study Design
Recruitment of Participants
UC Patients Patients treated at the Gastroenterology Clinic Sahlgrenska University Hospital will be invited via mail and follow-up phone calls This study aims to recruit 100 patients 18-65 years on maintenance treatment with anti-TNF agents andor thiopurines or 5-ASA
Healthy subjects Recruited through local advertising at Sahlgrenska University Hospital and social media This study aims to recruit 50 healthy participants as control 18-65 years
All research subject will be informed and asked verbally to participate in the study Those who agree will sign informed consent
Intervention
All study participants will be randomized to receive either 10 g of dietary fiber per day divided into 2 doses or 10 g of placebo glucose divided into 2 doses for 3 weeks before the influenza vaccination They will continue to take dietary fiber or placebo for 3-4 weeks after the vaccination
The dietary fiber mix total 10 gday includes inulin acetylated polymannose galacto-oligosaccharides and resistant starch Intervention products were provided by Calmino group AB Sweden
All research subjects will be vaccinated after 3 weeks of intervention period The vaccination procedure and dosage will be the same as in standard clinical practice
All participants will complete questionnaires to assess GI symptom severity and blood and fecal samples will be collected at baseline 3 weeks after intervention vaccination visit 6 weeks after interventionend of intervention 3 weeks post-vaccination and at long term follow-up 20-25 weeks post-vaccination
Significance
This is the first time the impact of dietary fibers on vaccination response is being studied in UC patients treated with anti-inflammatory drugs If the study shows favorable results it could lead to changes in clinical practice including advising patients to intake dietary fiber to enrich gut flora improve immune response and enhance protection during vaccination
The purpose of the study is to determine if dietary fibers can improve the immune response to influenza vaccination in UC patients treated with immunosuppressive medications The investigators also intend to determine if dietary fibers prebiotics can enrich the composition and function of the gut microbiota in UC patients
Background and Justification
Patients with moderate to severe UC often require lifelong medical treatment Long-term treatment typically includes medications such as 5-ASA immunomodulatory agents like thiopurines andor antibodies or biologics that block pro-inflammatory cytokines These medical treatments aim to suppress the patients inflammatory activity both systemically and locally in the gut The treatment is often effective leading to complete or partial healing of gut inflammation known as remission Unfortunately the treatment also makes patients more susceptible to infections and results in a poorer response to certain types of vaccinations
Patients with UC are a high-risk group and are encouraged to vaccinate against the seasonal influenza virus Vaccination activates immune cells to produce antibodies that protect against the influenza virus The effectiveness of the vaccination is measured by the levels titers of influenza-specific antibodies formed Previous studies have shown that patients treated with biologics such as antibodies against the pro-inflammatory cytokine TNF have a poorer response to various vaccinations including influenza and therefore receive less protection against the infection
Recent studies have shown that the composition of the gut microbiota at the time of vaccination affects the responseprotection from vaccination in healthy volunteers The studies also implicate research subjects with a poorermore depleted composition of gut bacteria with a reduced ability to form antibodies and thus create immunological protection in response to vaccination It is known that UC patients have a depleted composition of gut bacteria compared to healthy individuals
Previous studies have suggested that it may be possible to improve the composition of gut bacteria in UC patients by enriching the diet with dietary fibers known as prebiotics which promote the presence of certain gut bacteria believed to have health-promoting effects There are many different types of dietary fibers consisting of carbohydrates and starch Examples of dietary fibers include inulin mannose galacto-oligosaccharides and starch
Study Design
Recruitment of Participants
UC Patients Patients treated at the Gastroenterology Clinic Sahlgrenska University Hospital will be invited via mail and follow-up phone calls This study aims to recruit 100 patients 18-65 years on maintenance treatment with anti-TNF agents andor thiopurines or 5-ASA
Healthy subjects Recruited through local advertising at Sahlgrenska University Hospital and social media This study aims to recruit 50 healthy participants as control 18-65 years
All research subject will be informed and asked verbally to participate in the study Those who agree will sign informed consent
Intervention
All study participants will be randomized to receive either 10 g of dietary fiber per day divided into 2 doses or 10 g of placebo glucose divided into 2 doses for 3 weeks before the influenza vaccination They will continue to take dietary fiber or placebo for 3-4 weeks after the vaccination
The dietary fiber mix total 10 gday includes inulin acetylated polymannose galacto-oligosaccharides and resistant starch Intervention products were provided by Calmino group AB Sweden
All research subjects will be vaccinated after 3 weeks of intervention period The vaccination procedure and dosage will be the same as in standard clinical practice
All participants will complete questionnaires to assess GI symptom severity and blood and fecal samples will be collected at baseline 3 weeks after intervention vaccination visit 6 weeks after interventionend of intervention 3 weeks post-vaccination and at long term follow-up 20-25 weeks post-vaccination
Significance
This is the first time the impact of dietary fibers on vaccination response is being studied in UC patients treated with anti-inflammatory drugs If the study shows favorable results it could lead to changes in clinical practice including advising patients to intake dietary fiber to enrich gut flora improve immune response and enhance protection during vaccination
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None