Effect and Mechanism of Baitouweng Decoction for Large Intestine Damp-heat Syndrome of Ulcerative Colitis

NCT06421818 | Recruiting Phase 2 DMC

• 1 other identifier: BTW-RCT
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

Baitouweng Decoction is traditionally used to treat large intestine damp-heat syndrome of ulcerative colitis (UC) by oral administration and rectal enema.The project applicant's 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.

Conditions

Ulcerative Colitis

Keywords

Baitouweng Decoction; Formula-to-Syndrome Effect; Ulcerative colitis; Pharmacomicrobiomics; Colon delivery

Outcome Measures

Primary Outcomes (1)

• The concentration of fecal calprotecin.

  To compare the concentration of fecal calprotecin before and after oral, colonic TET and rectal enema administration.

  Baseline; Day 15; Day 53

Secondary Outcomes (2)

• The change of Mayo score.

  Baseline; Day 15; Day 22; Day 53; Day 99.

• Incidence of Treatment-Emergent Adverse Events

  Day 15; Day 22; Day 53; Day 99.

Study Arms (4)

Colonic TET treatment group

EXPERIMENTAL

Baitouweng Decoction is administered through the colonic TET.

Drug: Baitouweng Tang

Colonic TET placebo group

PLACEBO COMPARATOR

The same volume of placebo as the colonic TET treatment group was administered through the colonic TET.

Other: Placebo

Rectal enema group

ACTIVE COMPARATOR

Baitouweng Decoction is administered through rectal enema.

Drug: Baitouweng Tang

Oral group

ACTIVE COMPARATOR

Baitouweng Decoction is administered through oral.

Drug: Baitouweng Tang

Interventions

Baitouweng Tang DRUG

Baitouweng Decoction is composed of four herbs: Baitouweng, Rhizoma coptidis, Phellodendri huangbai and Qin Pi.

Also known as: Baitouweng Decoction

Colonic TET treatment group; Oral group; Rectal enema group

Placebo OTHER

The same volume and color as Baitouweng Decoction.

Colonic TET placebo group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with ulcerative colitis;
• The patients are in mild to moderate active stage with Mayo score of 3-8.
• Patients with damp-heat syndrome of large intestine according to TCM syndrome differentiation: according to the expert consensus on integrated traditional Chinese and Western medicine diagnosis and treatment of UC, the main symptoms are diarrhea, mucopurulent and bloody stool, abdominal pain, and tenesmus. Secondary symptoms: anal burning, body heat is not Yang, dry mouth and bitter mouth, short red urine. Tongue pulse: tongue red fur yellow greasy, pulse slippery number. The determination of the above 8 syndromes can be made if there are 2 main symptoms and 1-2 secondary symptoms. The tongue pulse is for reference only.
• The patients who can tolerate Baitouweng Decoction;
• The patients who tolerance to colonoscopy and TET;
• The patients who know and agree to participate in the clinical trial.

You may not qualify if:

• The patients are complicated with other diseases that may cause diarrhea, such as infectious colitis, radiation enteritis, Crohn's disease, etc.
• Patients with heart, brain, lung, liver, kidney and other serious diseases;
• Patients do not cooperate to complete the clinical trial process;

Sponsors & Collaborators

• The Second Hospital of Nanjing Medical University: lead
• Heilongjiang University of Chinese Medicine: collaborator

Study Sites (1)

Department of Microbiota Medicine & Medical Centre for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

RECRUITING

Related Publications (5)

• Wang W, Lu G, Wu X, Wen Q, Zhang F. Colonic Transendoscopic Enteral Tubing Is a New Pathway to Microbial Therapy, Colonic Drainage, and Host-Microbiota Interaction Research. J Clin Med. 2023 Jan 18;12(3):780. doi: 10.3390/jcm12030780.

  PMID: 36769429 BACKGROUND

• Zhang X, Zhang L, Chan JCP, Wang X, Zhao C, Xu Y, Xiong W, Chung WC, Liang F, Wang X, Miao J, Bian Z. Chinese herbal medicines in the treatment of ulcerative colitis: a review. Chin Med. 2022 Apr 4;17(1):43. doi: 10.1186/s13020-022-00591-x.

  PMID: 35379276 RESULT

• Gou H, Su H, Liu D, Wong CC, Shang H, Fang Y, Zeng X, Chen H, Li Y, Huang Z, Fan M, Wei C, Wang X, Zhang X, Li X, Yu J. Traditional Medicine Pien Tze Huang Suppresses Colorectal Tumorigenesis Through Restoring Gut Microbiota and Metabolites. Gastroenterology. 2023 Dec;165(6):1404-1419. doi: 10.1053/j.gastro.2023.08.052. Epub 2023 Sep 12.

  PMID: 37704113 RESULT

• Wei P, He Q, Liu T, Zhang J, Shi K, Zhang J, Liu S. Baitouweng decoction alleviates dextran sulfate sodium-induced ulcerative colitis by suppressing leucine-related mTORC1 signaling and reducing oxidative stress. J Ethnopharmacol. 2023 Mar 25;304:116095. doi: 10.1016/j.jep.2022.116095. Epub 2022 Dec 26.

  PMID: 36581160 RESULT

• Gu X, Miao Z, Wang Y, Yang Y, Yang T, Xu Y. New Baitouweng decoction combined with fecal microbiota transplantation alleviates DSS-induced colitis in rats by regulating gut microbiota metabolic homeostasis and the STAT3/NF-kappaB signaling pathway. BMC Complement Med Ther. 2022 Nov 24;22(1):307. doi: 10.1186/s12906-022-03766-z.

  PMID: 36424592 RESULT

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

baitouweng tang

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Faming Zhang, PhD

  The Second Hospital of Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Faming Zhang, PhD

CONTACT

02558509670; fzhang@njmu.edu.cn

Bota Cui

CONTACT

02558509883; cuibota@njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: For groups receiving Baitouweng Decoction by oral administration and rectal edema，the interventions are single-blind to investigators and outcomes assessor. For groups receiving Baitouweng Decoction or placebo by colonic TET, the interventions are double-blind to participants, care provider, investigators and outcomes assessor.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician, PhD

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: May 20, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: May 21, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)