Ignite Creation Date:
2024-05-06 @ 7:02 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05874830
Status:
RECRUITING
Last Update Posted:
2023-05-25
First Post:
2022-04-17
Brief Title:
The Optimal Route of Fecal Microbiota Transplantation for Irritable Bowel Syndrome
Sponsor:
Turku University Hospital
Organization:
Turku University Hospital
Study Overview
Official Title:
The Optimal Route of Fecal Microbiota Transplantation for Irritable Bowel Syndrome
Status:
RECRUITING
Status Verified Date:
2023-05
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:
None
Brief Summary:
The object of this study is to find out is there an optimal route for the fecal microbiata transplant FMT in patients that suffer from irritable bowel syndrome The investigators compare outcomes in patients with repeated fecal microbiome samples and make symptomatic questionnaires ie IBS-SSS GSRS to find out if there is difference in severity of symptoms compared to FMT given in duodenogastroscopy or in coloscopy
Detailed Description:
Irritable bowel syndrome IBS is a common functional disorder affecting approximately 10 globally1 It is often referred to as benign although when severe may cause significant reduction of quality of life and work absenteeism The etiology of IBS is unknown although many theories have been proposed Altered gut motility epithelial hyperpermeability low grade inflammation visceral hypersensitivity epigenetics and genetics altered gut-brain interaction and psychological stressors have all been reported in patients with IBS
Several studies have detected alterations in the gut microbiota composition between IBS patients and healthy controls however a microbiota typical for IBS patients has not been conclusively defined
Fecal microbiota transplantation has over 90 efficace in recurrent Clostridioides difficile infection rCDI for which it has been in clinical use for a decade FMT is currently recommended after the second relapse of rCDI FMT is recommended to be considered only in clinical trial settings for other indications than rCDI
Randomized controlled studies in FMT for IBS have conflicting results In studies with a single administration of FMT in colonoscopy a mild transient reduction of IBS symptoms has followed the intervention In studies with fecal capsules there has not been any benefit observed FMT via gastroscopy exerted a clear benefit with an up to 891 response rate These surprisingly good results were thought to be contributable to careful donor selection however the study included only one donor and no specific characteristics of microbiota were indentified of the suspected superdonor Although all these three administration routes altered the microbiota of IBS patients towards that of the donor a concurrent decrease in the symptoms was observed only when FMT was administered via colonoscopy or gastroscopy
Manipulation of microbiota through FMT remains to be potential treatment option for IBS however several mechanistic questions await answering Investigators do not yet know what is the component of stool which would carry the healing potential There needs to be further research to define optimal donors as well as optimal patients who would be prone to benefit of FMT The amount and number of FMT treatments may be a factor contributing to the outcome
It is also undefined in which extend does the route of administration of FMT contribute to the outcome in IBS patients Therefore the investigators present a placebo-controlled trial the optimal route to provide further mechanistic knowledge of the optimal FMT protocol in this patient group
Several studies have detected alterations in the gut microbiota composition between IBS patients and healthy controls however a microbiota typical for IBS patients has not been conclusively defined
Fecal microbiota transplantation has over 90 efficace in recurrent Clostridioides difficile infection rCDI for which it has been in clinical use for a decade FMT is currently recommended after the second relapse of rCDI FMT is recommended to be considered only in clinical trial settings for other indications than rCDI
Randomized controlled studies in FMT for IBS have conflicting results In studies with a single administration of FMT in colonoscopy a mild transient reduction of IBS symptoms has followed the intervention In studies with fecal capsules there has not been any benefit observed FMT via gastroscopy exerted a clear benefit with an up to 891 response rate These surprisingly good results were thought to be contributable to careful donor selection however the study included only one donor and no specific characteristics of microbiota were indentified of the suspected superdonor Although all these three administration routes altered the microbiota of IBS patients towards that of the donor a concurrent decrease in the symptoms was observed only when FMT was administered via colonoscopy or gastroscopy
Manipulation of microbiota through FMT remains to be potential treatment option for IBS however several mechanistic questions await answering Investigators do not yet know what is the component of stool which would carry the healing potential There needs to be further research to define optimal donors as well as optimal patients who would be prone to benefit of FMT The amount and number of FMT treatments may be a factor contributing to the outcome
It is also undefined in which extend does the route of administration of FMT contribute to the outcome in IBS patients Therefore the investigators present a placebo-controlled trial the optimal route to provide further mechanistic knowledge of the optimal FMT protocol in this patient group
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