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

NCT07318753 | Active Not Recruiting DMC

• 1 other identifier: ShenzhenHZHW
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Inflammatory Bowel Disease (IBD)

Keywords

gut microbiota; IBD; Crohn's disease; Ulcerative Colitis; DL-endopeptidase

Outcome Measures

Primary Outcomes (1)

• Modified Mayo endoscopic score

  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

  3 months

Secondary Outcomes (3)

• The changes in gut microbiota structure

  3 months

• The Levels of NOD2 in the gut

  3 months

• Endoscopic scoring（SES⁃CD/UCEIS）

  3 months

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Dietary Supplement: Lactobacillus rhamnosus CALM 607（LR607）

Control

NO INTERVENTION

Take 2 grams of placebo daily from days 1 to 5, and 4 grams daily from days 6 to 90.

Interventions

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.

Experimental group

Eligibility Criteria

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

You may qualify if:

• \. 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Shenzhen Hospital of Southern Medical University: lead

Study Sites (1)

Shenzhen Hospital of Southern Medical University

Shenzhen, Guangdong, 518000, China

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Shenzhen Hospital of Southern Medical University

Study Record Dates

• First Submitted: November 30, 2025
• First Posted: January 6, 2026
• Study Start: June 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)