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Active, not recruitingNCT07318753Updated Jan 12, 2026

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

An interventional study of Lactobacillus rhamnosus CALM 607（LR607） in Inflammatory Bowel Disease (IBD), sponsored by Shenzhen Hospital of Southern Medical University. Active, not recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2026-01-12.

Sponsored by Shenzhen Hospital of Southern Medical University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2026, 3 months ago, but the record still lists the study as active, not recruiting.
  • Registered 5 months after the study started (first participant enrolled Jun 2025, registered Nov 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Randomized
Sex
All
01

Study 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.

02

Conditions studied

  • Inflammatory Bowel Disease (IBD)

Keywords

  • gut microbiota
  • IBD
  • Crohn's disease
  • Ulcerative Colitis
  • DL-endopeptidase
03

In context

Inflammatory Bowel Diseases

1,460 studies on the registry are indexed under Inflammatory Bowel Diseases; 437 are open to participants now.

This study's planned enrollment of 300 is above the median of 70 across 770 interventional studies indexed under Inflammatory Bowel Diseases.

Browse Inflammatory Bowel Diseases studies →

Lead sponsor

Shenzhen Hospital of Southern Medical University is the lead sponsor of 9 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

1. 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)'.

  1. Patients with non-infectious UC initially diagnosed through laboratory tests, endoscopy, and pathological biopsy;
  2. 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;
  3. In the active phase, with a clinical treatment plan using only mesalazine;
  4. Voluntarily participating in this clinical trial, understanding, and signing the informed consent form.

2. 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)'.

  1. Patients with non-infectious Crohn's disease (CD) initially diagnosed through laboratory tests, endoscopic examination, and pathological biopsy;
  2. 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;
  3. Voluntarily participating in this clinical trial, having understood and signed the informed consent form.

Exclusion criteria

Exclusion Criteria:

1. 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)'.

  1. Patients who have changed medication dosage or type in the past 2 months;
  2. Patients who have the history of antibiotics, probiotics, or other medications affecting gut microbiota for non-target diseases within the past 2 months;
  3. Patients who have the history of immunosuppressive drugs such as methotrexate or glucocorticoids ;
  4. Patients who have the history of malignant tumors, other immune system diseases, or other serious chronic diseases;
  5. 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;
  6. Pregnant or preparing for pregnancy and breastfeeding women;
  7. Other situations deemed necessary to exclude by the researcher, for example: Simultaneous participation in other clinical interventional studies that may interact with this study.

2. 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)'.

  1. Patients who have changed medication dosage or type in the past 2 months;
  2. Patients who have the history of antibiotics, probiotics, or other medications affecting gut microbiota for non-target diseases within the past 2 months;
  3. Patients who have the history of malignant tumors, other immune system diseases, or other serious chronic diseases;
  4. 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;
  5. Pregnant or preparing for pregnancy and breastfeeding women;
  6. Other situations deemed necessary to exclude by the researcher, for example: Simultaneous participation in other clinical interventional studies that may interact with this study.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
300 participants (estimated)

Study arms

  • Experimental
    Experimental group

    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）

  • No intervention
    Control

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

Interventions

  • Dietary supplementLactobacillus rhamnosus CALM 607（LR607）

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

06

What researchers measure

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

    Time frame: 3 months

Secondary outcomes

  1. The changes in gut microbiota structure

    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.

    Time frame: 3 months

  2. The Levels of NOD2 in the gut

    Time frame: 3 months

  3. Endoscopic scoring（SES⁃CD/UCEIS）

    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;

    Time frame: 3 months

07

Study locations

1 site
  • Shenzhen Hospital of Southern Medical University
    Shenzhen, Guangdong 518000, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07318753
Lead sponsor
Shenzhen Hospital of Southern Medical University
Responsible party
Hongwei Zhou (Shenzhen Hospital of Southern Medical University, Shenzhen Hospital of Southern Medical University) — Principal investigator
First posted
Jan 6, 2026
Start date
Jun 1, 2025
Primary completion
Jul 2026 (estimated)
Completion
Oct 2026 (estimated)
Last update
Jan 12, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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