CMTS0929 for Inflammatory Bowel Disease

NCT06844708 | Not Yet Recruiting Early Phase 1 DMC

• 1 other identifier: 2024CMTS0929-IBD
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, open-label, single-arm study to explore the safety and the efficacy of China Microbiota Transplantation System 0929 (CMTS0929) for patients with inflammatory bowel disease (IBD).

Conditions

Inflammatory Bowel Disease (IBD)

Keywords

inflammatory bowel disease; CMTS0929; efficacy; safety

Outcome Measures

Primary Outcomes (2)

• The efficacy of China Microbiota Transplantation System 0929 (CMTS0929)

  Partial Mayo scale for Ulcerative Colitis (UC), the minimum score is 0, the score ≤2 and no single sub-score was \>1 is clinical remission, 3-5 as mild activity, 6-10 as moderate activity, 11-12 as severe activity.

  Four-week

• The efficacy of China Microbiota Transplantation System 0929 (CMTS0929)

  Crohn disease activity index (CDAI) for Crohn's disease (CD), the minimum value is 0, ≤ 4 is remission，5-7 is mild，8-16 is moderate, \> 16 is severe, higher scores mean a worse outcome.

  Four-week

Secondary Outcomes (7)

• The changes in endoscopic score

  Three-month, Six-month

• The change in hematochezia compared with baseline

  One-week, Four-week, Twelve-week, Six-month

• The change in frequency of defecation compared with baseline

  One-week, Four-week, Twelve-week, Six-month

• The change in abdominal pain compared with baseline

  One-week, Four-week, Twelve-week, Six-month

• The incidence of IBD-related complications

  One-week, Four-week, Twelve-week, Six-month

Study Arms (1)

Treatment

EXPERIMENTAL

Eligible subjects will receive treatment with China Microbiota Transplantation System 0929 (CMTS0929). They will be administered one unit of the liquid via colonic transendoscopic enteral tube (cTET) for three consecutive days.

Biological: CMTS0929

Interventions

CMTS0929 BIOLOGICAL

China Microbiota Transplantation System 0929 (CMTS0929) is defined as suspension from washed microbiota.

Treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with inflammatory bowel disease (IBD) based on typical clinical symptoms, endoscopic findings, and histological criteria.
• Aged between 18 and 75 years old, regardless of gender.
• No history of using antibiotics, prebiotics, or probiotics within at least the past month.
• Patients who can fully understand the content of the informed consent form for this trial and voluntarily sign the written informed consent.
• Patients willing to undergo subsequent follow - up and comply with other requirements of the protocol.

You may not qualify if:

• Women who are pregnant or plan to become pregnant during the trial.
• Patients who have any doubts about this technology or have a history of other risks.
• Patients in the terminal stage of the disease or who may die during the study.
• Patients with a history of antibiotic use within three months before transplantation or who have participated in other clinical trials.
• Patients who have participated in any other microbiota - based therapies before enrollment.
• Patients with positive antibodies for hepatitis B, tuberculosis, syphilis, or HIV, or those in the acute phase of any infectious disease.
• Patients with cardiac function at grade III or higher, elevated transaminases more than twice the upper limit of the normal range, or renal insufficiency (glomerular filtration rate (GFR) less than 60 ml/min).
• Patients with a fever of over 38 °C or clinically obvious active infections that may affect this trial.
• Patients with severe anemia (hemoglobin \< 60 g/L), granulocytopenia (absolute neutrophil count \< 1.5×10⁹/L), or prolonged prothrombin time (PT) by more than 1.5 seconds.
• Patients with obvious cardiovascular and cerebrovascular abnormalities (such as tachycardia or uncontrolled atrial fibrillation, acute coronary syndrome, stroke, or recurrent transient ischemic attacks (TIAs)); a history of arrhythmia (multifocal ventricular premature beats, bigeminy, trigeminy, congenital long QT syndrome), or patients with heart diseases that, in the judgment of the researcher, increase the risk of ventricular arrhythmia.
• Situations identified by the researcher during the trial that may affect the patient's compliance and/or the completion of trial - related procedures, or clinical contraindications related to the pre - trial.
• Patients who have undergone abdominal organ surgery within three months before treatment, patients less than 6 weeks after major organ surgery, or patients with poor wound healing after surgery.
• Patients with gastrointestinal obstructive diseases, tumors, or hepatic or renal insufficiency.
• Pregnant or lactating women, or women with the intention of becoming pregnant.
• Patients suspected or confirmed to be drug users, or those with a history of immunodeficiency (such as positive HIV antibodies or currently receiving immunosuppressive therapy).

Sponsors & Collaborators

• The Second Hospital of Nanjing Medical University: lead

Study Sites (1)

Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Location

Related Publications (6)

• Wortelboer K, de Jonge PA, Scheithauer TPM, Attaye I, Kemper EM, Nieuwdorp M, Herrema H. Phage-microbe dynamics after sterile faecal filtrate transplantation in individuals with metabolic syndrome: a double-blind, randomised, placebo-controlled clinical trial assessing efficacy and safety. Nat Commun. 2023 Sep 12;14(1):5600. doi: 10.1038/s41467-023-41329-z.

  PMID: 37699894 BACKGROUND

• Shaukat A, Shyne M, Mandel JS, Snover D, Church TR. Colonoscopy With Polypectomy Reduces Long-Term Incidence of Colorectal Cancer in Both Men and Women: Extended Results From the Minnesota Colon Cancer Control Study. Gastroenterology. 2021 Mar;160(4):1397-1399.e3. doi: 10.1053/j.gastro.2020.11.014. Epub 2020 Nov 17. No abstract available.

  PMID: 33217449 BACKGROUND

• Zhang F, Cui B, He X, Nie Y, Wu K, Fan D; FMT-standardization Study Group. Microbiota transplantation: concept, methodology and strategy for its modernization. Protein Cell. 2018 May;9(5):462-473. doi: 10.1007/s13238-018-0541-8. Epub 2018 Apr 24.

  PMID: 29691757 BACKGROUND

• Piovani D, Hassan C, Repici A, Rimassa L, Carlo-Stella C, Nikolopoulos GK, Riboli E, Bonovas S. Risk of Cancer in Inflammatory Bowel Diseases: Umbrella Review and Reanalysis of Meta-analyses. Gastroenterology. 2022 Sep;163(3):671-684. doi: 10.1053/j.gastro.2022.05.038. Epub 2022 May 26.

  PMID: 35643170 BACKGROUND

• Ungaro R, Mehandru S, Allen PB, Peyrin-Biroulet L, Colombel JF. Ulcerative colitis. Lancet. 2017 Apr 29;389(10080):1756-1770. doi: 10.1016/S0140-6736(16)32126-2. Epub 2016 Dec 1.

  PMID: 27914657 BACKGROUND

• Hodson R. Inflammatory bowel disease. Nature. 2016 Dec 21;540(7634):S97. doi: 10.1038/540S97a. No abstract available.

  PMID: 28002398 BACKGROUND

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Faming Zhang, PhD

  The Second Hospital of Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Faming Zhang, PhD

CONTACT

086-025-58509883; fzhang@njmu.edu.cn

Bota Cui, MD

CONTACT

086-025-58509884; cuibota@njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Gastroenterology

Model Details: Eligible subjects will receive treatment with CMTS0929. They will be administered one unit of the liquid via colonic transendoscopic enteral tube (cTET) for three consecutive days.

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: February 25, 2025
• Study Start: February 20, 2025
• Primary Completion (Estimated): January 31, 2030
• Study Completion (Estimated): July 1, 2030
• Last Updated: February 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)