Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06421818
Status:
RECRUITING
Last Update Posted:
2024-05-21
First Post:
2024-05-14
Brief Title:
Effect and Mechanism of Baitouweng Decoction for Large Intestine Damp-heat Syndrome of Ulcerative Colitis
Sponsor:
The Second Hospital of Nanjing Medical University
Organization:
The Second Hospital of Nanjing Medical University
Study Overview
Official Title:
Formula-to-Syndrome Effect and Pharmacomicrobiomics Mechanism of Colon Delivery of Baitouweng Decoction for Treating Large Intestine Damp-heat Syndrome of Ulcerative Colitis
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:
None
Brief Summary:
Baitouweng Decoction is traditionally used to treat large intestine damp-heat syndrome of ulcerative colitis UC by oral administration and rectal enemaThe project applicants invention of transendoscopic entral tubing TET has been used in Baitouweng Decoction for the treatment of UC across the whole colon however the efficacy have not been reported and the underlying mechanism is still unclear Compared with oral and rectal enema Baitouweng Decoction by colon TET can improve the therapeutic effect by increasing the concentration of drugs in the whole colon which need to be verified This project will reveal the prescription effect and drug-microbiome interaction mechanism of whole colon repeated administration of Baitouweng Decoction in the treatment of UC through clinical randomized controlled studies deep intestinal dynamic sampling integrated analysis of multi-omics and TCM prescription metabolomics studies and provide key scientific basis for the establishment of a new approach of whole colon repeated administration of TCM and a new strategy for the treatment of UC
Detailed Description:
A multi-center randomized controlled study will be conducted to compare the efficacy differences and multi-omics changes of colon TET rectal enema and oral Baitouweng Decoction in the control of intestine damp-heat syndrome of UC Moreovera group of patients was designed to receive blank carrier solution through colon TET tube After the study the patients in this group were given compensation treatment of fecal microbiota transplantation as an ethical protection measureThe colonic TET will be implanted into the intestine and the whole colon will be covered with Baitouweng Decoction The treatment period is 10 days The primary outcome measure is the changes of fecal calprotectin before and after oral colonic TET and rectal enema administration And the secondary outcomes measure are the changes of disease condition Mayo score and safety Deep intestine fluid stool blood and urine samples were collected before and after treatment to study the changes of microbiomes metabolomics and immunoomics Identify the difference of the key material basis of Baitouweng Decoction and analyze its mechanism comprehensively The key beneficial and harmful bacteria were identified by comprehensive analysis A total of not less than 144 subjects are expected to be included and divided into colonic TET treatment group colonic TET placebo group rectal enema group and oral group according to a ratio of 1111
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