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Evaluate the Efficacy and Safety of Probiotic 6600 as an Adjuvant Therapy for Colitis

NCT07047339 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-07-02

No results posted yet for this study

Summary

This study was conducted in two phases. In Phase I, 40 UC participants, 40 CD participants, and 40 colitis participants were randomly assigned in a 1:1 ratio to the experimental group and the control group, respectively. The study included a screening period (1 week), a double-blind treatment period (24 weeks), an exit examination (1 day), and a safety follow-up period (4 weeks). After providing informed consent, participants who met the inclusion criteria and those who did not meet the exclusion criteria were randomly assigned, in a 1:1 ratio, to receive either the trial (probiotic 6600 capsules) or the control group (placebo). The clinical remission rate (SCCAI score ≤2 and no single subscore \>1) after 24 weeks of treatment was calculated. Mayo score ≤2 and no single subscore \>1; CDAI score ≤2 and no single subscore \>1) were used as the primary efficacy index.

Conditions

  • Colitis
  • IBD (Inflammatory Bowel Disease)
  • Probiotic Intervention

Interventions

DRUG

Probiotics 6600

As the core commensal bacteria of human body, probiotic 6600 has a unique ability to synthesize adhesins and exopolysaccharides. The intestinal protective effect is mediated by the following mechanisms: (1) regulation of Treg/Th17 balance by producing short-chain fatty acids (SCFAs); (2) activation of TLR2/MyD88 pathway inhibits NF-κB inflammatory cascade; (3) Upregulation of zonula occludens-1 enhances intestinal barrier function. Notably, this strain specifically metabolized arabinoxylan to produce the anti-inflammatory metabolite indole lactate, which has important therapeutic value in the colitis microenvironment. Probiotic 6600 capsules are enteric capsules (containing probiotic 6600 10\^11 CFU/ capsule), taken orally twice a day (after meals in the morning and evening), one capsule each time, and taken with warm water. The drug was stored at 2-8℃.

DRUG

Placebo

The placebo capsules were also enteric-coated capsules, and were taken orally twice a day (morning and evening after meals), one capsule each time, with warm water.

Sponsors & Collaborators

  • Changhai Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2026-07-01
Completion
2026-12-31

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07047339 on ClinicalTrials.gov