Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07318753

A Clinical Study on The Use of DL-endopeptidase-producing Probiotics as an Adjunctive Therapy for Inflammatory Bowel Disease.

Through a series of studies,the investigators has discovered for the first time that gut microbiota-derived DL-endopeptidase is a core regulator of the NOD2 pathway. This research also reveals a novel etiological mechanism in which deficiency of gut bacterial DL-endopeptidase leads to dysfunctional NOD2 signaling, thereby promoting the pathogenesis of inflammatory bowel disease (IBD).( The findings have been published in Cell Host & Microbe and Nature Communications.) Based on this, the investigators has successfully screened a high DL-endopeptidase-producing active strain, Lactobacillus rhamnosus CALM 607 (abbreviated as LR607), from the traditional probiotic Lactobacillus rhamnosus.(Its unique advantages include: 1) Independent intellectual property rights (patent applied for);2) DL-endopeptidase production and NOD2 regulatory ability 2.7 times higher than that of the conventional strain LGG;3) Preclinical experiments have demonstrated its potential to alleviate intestinal inflammation.) The investigators' Phase I clinical trial (data pending publication) has confirmed that LR607 has good safety and tolerability in healthy volunteers, providing a safety foundation for subsequent clinical studies.

Therefore, the investigators aim to investigate the DL-endopeptidase-producing probiotic LR607 through randomized controlled clinical intervention studies, to evaluate its adverse effects in adjunctive therapy and comprehensively assess its impact on the gut microbiome-NOD2 pathway, intestinal inflammation, and the progression of IBD.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Inflammatory Bowel Disease (IBD) Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shenzhen Hospital of Southern Medical University

Shenzhen, Guangdong, 518000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with ulcerative colitis (UC) Patients diagnosed with UC according to the 'Chinese Guidelines for the Diagnosis and Treatment of Ulcerative Colitis (2023, Xi'an)'.
  • Patients with non-infectious UC initially diagnosed through laboratory tests, endoscopy, and pathological biopsy;
  • According to the latest guideline standards, clinically diagnosed with mild to moderate disease; defined as a modified Mayo score of 3-9 points; and classified as mild to moderate based on the modified Truelove and Witts severity classification;
  • In the active phase, with a clinical treatment plan using only mesalazine;
  • Voluntarily participating in this clinical trial, understanding, and signing the informed consent form.
  • Patients with Crohn's disease (CD) Patients diagnosed with Crohn's disease (CD) according to the 'Chinese Guidelines for the Diagnosis and Treatment of Crohn's Disease (2023, Guangzhou)'.
  • Patients with non-infectious Crohn's disease (CD) initially diagnosed through laboratory tests, endoscopic examination, and pathological biopsy;
  • Clinically diagnosed as having mild to moderate disease according to the latest guideline standards, defined as a Crohn's Disease Activity Index (BestCDAI) score of 150-450;
  • Voluntarily participating in this clinical trial, having understood and signed the informed consent form.

Exclusion criteria

  • Patients with ulcerative colitis (UC) Patients diagnosed with UC according to the 'Chinese Guidelines for the Diagnosis and Treatment of Ulcerative Colitis (2023, Xi'an)'.
  • Patients who have changed medication dosage or type in the past 2 months;
  • Patients who have the history of antibiotics, probiotics, or other medications affecting gut microbiota for non-target diseases within the past 2 months;
  • Patients who have the history of immunosuppressive drugs such as methotrexate or glucocorticoids ;
  • Patients who have the history of malignant tumors, other immune system diseases, or other serious chronic diseases;
  • Patients who have Concurrent active infections, including but not limited to obvious gastrointestinal bleeding, local or systemic infectious symptoms due to severe gastrointestinal ulceration or bleeding;
  • Pregnant or preparing for pregnancy and breastfeeding women;
  • Other situations deemed necessary to exclude by the researcher, for example: Simultaneous participation in other clinical interventional studies that may interact with this study.
  • Patients with Crohn's disease (CD) Patients diagnosed with Crohn's disease (CD) according to the 'Chinese Guidelines for the Diagnosis and Treatment of Crohn's Disease (2023, Guangzhou)'.
  • Patients who have changed medication dosage or type in the past 2 months;
  • Patients who have the history of antibiotics, probiotics, or other medications affecting gut microbiota for non-target diseases within the past 2 months;
  • Patients who have the history of malignant tumors, other immune system diseases, or other serious chronic diseases;
  • Patients who have Concurrent active infections, including but not limited to obvious gastrointestinal bleeding, local or systemic infectious symptoms due to severe gastrointestinal ulceration or bleeding;
  • Pregnant or preparing for pregnancy and breastfeeding women;
  • Other situations deemed necessary to exclude by the researcher, for example: Simultaneous participation in other clinical interventional studies that may interact with this study.

Treatment and study plan

Lactobacillus rhamnosus CALM 607（LR607）

Dietary Supplement

Take 2 grams of probiotic powder(LR607) daily from day 1 to day 5, and 4 grams daily from day 6 to day 90.

Primary outcomes

  1. Modified Mayo endoscopic score

    Time frame: 3 months

    Modified Mayo endoscopic score is divided into diarrhea, blood in stool, mucosal appearance, and physician assessment, each with a score of 0 to 3.

    • Clinical remission: score <2 with no individual subscore >1 ;
    • Mild activity: 3-5 points;
    • Moderate activity: 6-10 points;
    • Severe activity: 11-12 points

Secondary outcomes

  1. The changes in gut microbiota structure

    Time frame: 3 months

    The gut microbiota composition was assessed through metagenomics before and after one and three months of taking probiotics or placebo. Compare and analyze the differences in gut microbiota structure at the three time points.

  2. The Levels of NOD2 in the gut

    Time frame: 3 months

  3. Endoscopic scoring（SES⁃CD/UCEIS）

    Time frame: 3 months

    SES⁃CD（4 parts: Including ulcer size, the proportion of intestinal segments with ulcers, the proportion of intestinal segments with non-ulcerative lesions, and strictures, each with a score of 0 to 3. Score the five intestinal segments (rectum, descending colon, transverse colon, ascending colon, and ileum) separately and calculate the total.）：

    • Remission phase: 0-2 points;
    • Mild activity: 3-6 points;
    • Moderate activity: 7-15 points;
    • Severe activity: ≥16 points; UCEIS（3 parts: Including vascular patterns(0-2 points), bleeding(0-3 points), and erosive ulcers(0-3points)）：
    • Remission phase: 0 points;
    • Mild activity: 1-3 points;
    • Moderate activity: 4-6 points;
    • Severe activity: 7-8 points;

Sponsors and collaborators

Lead sponsor

Shenzhen Hospital of Southern Medical University

Other

Registry information

Official study title

Shenzhen Hospital of Southern Medical University

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 6, 2026
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.