Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06286709
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-02-07
Brief Title:
FAecal Microbiota Transplantation in primaRy sclerosinG chOlangitis
Sponsor:
University of Birmingham
Organization:
University of Birmingham
Study Overview
Official Title:
FARGO A Randomised Phase IIa Multi-centre Placebo-controlled Trial of FAecal Microbiota Transplantation in primaRy sclerosinG chOlangitis
Status:
RECRUITING
Status Verified Date:
2024-05
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:
FARGO
Brief Summary:
FARGO is a randomised phase IIa multi-centre placebo-controlled trial to compare Faecal Microbiota Transplant FMT with placebo in patients with primary sclerosing cholangitis PSC and concomitant inflammatory bowel disease
Detailed Description:
Primary Sclerosing Cholangitis PSC is a chronic liver disease and there is no medical therapy proven to slow disease progression Many patients with PSC also develop inflammatory bowel disease IBD It has been shown that there is an imbalance of normal microbiome eg bacteria viruses fungi in the gut of people with PSC and IBD This imbalance is believed to contribute to the development and possibly worsening of liver disease in PSC
It is believed that Faecal Microbiota Transplant FMT treatment can restore the balance in the gut microbiome and that this can lead to reduction in symptoms of PSC and IBD and improve quality of life
FMT involves the transplantation of faeces or stool from a healthy individual to a person with PSC FMT is prepared from stool collected from unrelated anonymous healthy donors The stool is treated in a laboratory at the University of Birmingham The donors are carefully screened and the donated stool carefully tested to ensure that it is as clean and safe as possible before it is made into doses of FMT suitable for treatment purposes Data from treatment with FMT in other conditions including Inflammatory Bowel Disease IBD Clostridioides difficile Cdiff infection and PSC has shown FMT to be safe
The primary aim of the FARGO trial is to determine the efficacy of FMT in patients with PSC The FARGO trial will recruit 58 patients Half will be randomised to FMT and half to placebo The trial will be offered at a number of hospitals across England Patients will be involved in the trial for 50 weeks including a 2-week screening 8 treatments over 8 weeks and follow-up to 48 weeks post-randomisation Trial visits will include the collection of health history blood tests stool tests pregnancy tests if applicable medication reviews disease specific measures patient questionnaires and possible symptom and side-effect review Research blood urine stool and colonic biopsy samples will also be collected
It is believed that Faecal Microbiota Transplant FMT treatment can restore the balance in the gut microbiome and that this can lead to reduction in symptoms of PSC and IBD and improve quality of life
FMT involves the transplantation of faeces or stool from a healthy individual to a person with PSC FMT is prepared from stool collected from unrelated anonymous healthy donors The stool is treated in a laboratory at the University of Birmingham The donors are carefully screened and the donated stool carefully tested to ensure that it is as clean and safe as possible before it is made into doses of FMT suitable for treatment purposes Data from treatment with FMT in other conditions including Inflammatory Bowel Disease IBD Clostridioides difficile Cdiff infection and PSC has shown FMT to be safe
The primary aim of the FARGO trial is to determine the efficacy of FMT in patients with PSC The FARGO trial will recruit 58 patients Half will be randomised to FMT and half to placebo The trial will be offered at a number of hospitals across England Patients will be involved in the trial for 50 weeks including a 2-week screening 8 treatments over 8 weeks and follow-up to 48 weeks post-randomisation Trial visits will include the collection of health history blood tests stool tests pregnancy tests if applicable medication reviews disease specific measures patient questionnaires and possible symptom and side-effect review Research blood urine stool and colonic biopsy samples will also be collected
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?:
False
Is an FDA AA801 Violation?:
None