Ignite Creation Date:
2024-05-06 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04691544
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-26
First Post:
2020-12-15
Brief Title:
Donor Versus Autologous Fecal Microbiota Transplantation for Irritable Bowel Syndrome
Sponsor:
University Hospital of North Norway
Organization:
University Hospital of North Norway
Study Overview
Official Title:
Donor Versus Autologous Fecal Microbiota Transplantation for Irritable Bowel Syndrome a Double Blind Placebo-Controlled Randomized Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-02
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:
Many patients with irritable bowel syndrome IBS do not experience adequate symptom relief with current treatments The pathophysiology of IBS is diverse controversial and not completely understood The next disruptive frontier would be to find a cure where the effect is predictable and lasting The study groups phase 2 pilot trial was the first indication of a possible benefit from treating IBS with fecal microbiota transplantation FMT Number needed to treat only five Fecal microbiota transplantation versus placebo for moderate-to-severe irritable bowel syndrome a double-blind randomized placebo-controlled parallel-group single-centre trial he Lancet Gastroenterology and Hepatology 2018 Additional results from the same trial show that the treatment response may be predicted unpublished data and that the pathophysiologic mechanisms behind the treatment response also can be identified Effects of fecal microbiota transplantation in subjects with irritable bowel syndrome are mirrored by changes in gut microbiome Gut Microbes 2020 This study is the first phase 3 trial of FMT for IBS worldwide
The hypothesis of the trial is that donor FMT is more effective than placebo FMT in treating IBS with little adverse events or complications Patients 18 years with IBS are enrolled at five Norwegian Hospitals in this double blind randomized placebo controlled parallell-group multi center trial Participants are randomized to FMT from a healthy donor intervention group or their own feces placebo group The primary outcome is the proportion of patients with 75 points decrease in the Irritable bowel Symptom Severity score 90 days after treatment
The hypothesis of the trial is that donor FMT is more effective than placebo FMT in treating IBS with little adverse events or complications Patients 18 years with IBS are enrolled at five Norwegian Hospitals in this double blind randomized placebo controlled parallell-group multi center trial Participants are randomized to FMT from a healthy donor intervention group or their own feces placebo group The primary outcome is the proportion of patients with 75 points decrease in the Irritable bowel Symptom Severity score 90 days after treatment
Detailed Description:
None
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