Ignite Creation Date:
2024-07-17 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06475430
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-06-20
Brief Title:
Fecal Microbiota Transplantation in the Treatment of Major LARS
Sponsor:
Peking University Peoples Hospital
Organization:
Peking University Peoples Hospital
Study Overview
Official Title:
Evaluation of the Effectiveness of Fecal Microbiota Transplantation in the Treatment of Patients With Severe Low Anterior Resection Syndrome LARS
Status:
NOT_YET_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:
FMT-LARS
Brief Summary:
Randomized trial to assess FMT efficacy in improving bowel function for major LARS patients 40 subjects blinded randomized to FMT or probiotics Pre-post 16S sequencing 4-week follow-up for bowel symptoms 8-week microbiota analysis
Detailed Description:
This study is a rigorous single-center prospective double-blinded randomized controlled trial aiming to evaluate the effectiveness of fecal microbiota transplantation FMT in improving bowel function for patients with major low anterior resection syndrome LARS A total of 40 subjects are planned to be recruited and randomly assigned to the experimental group and the control group at a 11 ratio Prior to treatment all subjects will undergo 16S sequencing of intestinal microbiota to assess their intestinal microecological status During the treatment a colonoscopic colonic catheter will be placed via the anus with the experimental group receiving FMT solution matched to the patients microbiota for intra-intestinal administration while the control group will receive a standardized probiotic formula To ensure the impartiality of the study both patients and researchers administering the medication will be blinded to the trial drugs The study will continuously observe and record bowel symptoms after 4 weeks of treatment as well as 16S sequencing results of intestinal microbiota after 8 weeks Upon the completion of the entire study the blinding will be revealed and the results will be analyzed
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