Ignite Creation Date:
2024-05-06 @ 6:41 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05740319
Status:
RECRUITING
Last Update Posted:
2023-05-31
First Post:
2023-02-09
Brief Title:
Efficacy and Safety Evaluation of Fecal Microbiota Transplantation in Irritable Bowel Syndrome
Sponsor:
Shanghai Zhongshan Hospital
Organization:
Shanghai Zhongshan Hospital
Study Overview
Official Title:
Efficacy and Safety Evaluation of Fecal Microbiota Transplantation in Irritable Bowel Syndrome
Status:
RECRUITING
Status Verified Date:
2023-02
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:
Participants will be given FMT through oral capsules or nasojejunal tube once a month After three-time treatment participants were followed up for three months Participants complete specific scales to assess improvement in symptoms emotion and quality of life Besides they report adverse effects and collect fecal samples at each visit
Detailed Description:
This prospective single-arm interventional study aims to evaluate efficacy and safety of fecal microbiota transplantation in refractory IBS patients Patients meeting the inclusion and exclusion criteria will provide written informed consent and receive FMT from healthy donors for three times The administration methods include taking oral capsule or delivering microbiota suspension into the duodenum via nasojejunal tube The patients receive treatment once a month and will be followed up for 3 months Improvement in IBS symptoms emotion and quality of life were assessed through IBS symptom severity scale IBS-SSS Gastrointestinal symptom rating scale GSRS IBS-Global Assessment of Improvement IBS-GAI Self-rating Anxiety Scale SAS Self-rating Depression Scale SDS and IBS-Quality of Life IBS-QoL respectively Patients were asked to complete these scales and collect fecal samples at baseline post-FMT and at 1 2 3 and 4 months after FMT Primary endpoints were improvement in IBS-SSS score and global symptoms after three-time FMT Secondary endpoints include Change in GSRS score improvement in emotion and quality of life at post-FMT 1 and 6 months as well as change in fecal microbiota composition
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