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Not yet recruiting NCT07415473

Akkermansia Muciniphila Combined With Infliximab for Promoting Intestinal Mucosal Healing in Crohn's Disease

Phase IV Interventional Crohn's Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Infliximab, Akkermansia muciniphila + Infliximab.
Who it may be relevant to
Registry conditions: Crohn's Diseases. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Randomized, Controlled Trial Investigating the Efficacy of Akkermansia Muciniphila Combined With Infliximab in Promoting Intestinal Mucosal Healing in Patients With Crohn's Disease

Overview

This study aims to evaluate whether the combination of Akkermansia muciniphila with infliximab can improve intestinal mucosal healing in patients with Crohn's disease compared with infliximab alone.

Detailed description

This is a prospective, randomized, controlled clinical study designed to evaluate the efficacy of Akkermansia muciniphila combined with infliximab in patients with Crohn's disease.

Eligible patients will be randomly assigned to receive either intravenous infliximab at standard clinical doses combined with Akkermansia muciniphila supplementation administered once daily or intravenous infliximab alone. The primary endpoint is complete mucosal healing at Week 26, and the secondary endpoint include endoscopic remission, endoscopic response, clinical remission and clinical response at Week 26.

Interventions

  • Drug Infliximab
    Patients will receive infliximab alone administered intravenously at the standard dose of 5 mg/kg at Weeks 0, 2, and 6, followed by every 8 weeks thereafter.
  • Drug Akkermansia muciniphila + Infliximab
    Patients will receive oral Akkermansia muciniphila once daily starting at Week 0. Concurrently, they will receive intravenous infliximab at the standard dose of 5 mg/kg at Weeks 0, 2, and 6, followed by every 8 weeks thereafter.

Primary outcome measures

  • Complete mucosal healing [Time frame: From enrollment to the end of treatment at 26 weeks]
Secondary outcome measures (4)
  • Endoscopic remission [Time frame: From enrollment to the end of treatment at 26 weeks]
  • Endoscopic response [Time frame: From enrollment to the end of treatment at 26 weeks]
  • Clinical remission [Time frame: From enrollment to the end of treatment at 26 weeks]
  • Clinical response [Time frame: From enrollment to the end of treatment at 26 weeks]

Eligibility criteria

Inclusion criteria

  • Adult patients aged 18 to 75 years.
  • Documented diagnosis of Crohn's disease established at any time prior to screening by radiological, histological, or endoscopic evidence.
  • Active Crohn's disease at screening, defined as a Crohn's Disease Activity Index (CDAI) score between 220 and 450 (inclusive).
  • Adequate cardiac, renal and hepatic function, as assessed by the investigator based on screening laboratory tests, physical examination, and medical history, without findings that would pose an undue risk for study participation.
  • Willingness and ability to provide written informed consent.
  • Agreement to undergo all scheduled study procedures, including up to 3 endoscopic evaluations.

Exclusion criteria

  • Use of any biologic therapy (e.g., infliximab, adalimumab, ustekinumab, vedolizumab) within 8 weeks prior to screening.
  • Use of systemic antibiotics or any probiotic preparation within 4 weeks prior to screening.
  • History of any intestinal resection or other Crohn's disease-related surgery.
  • History of or active chronic or recurrent infectious disease.
  • History of or current malignancy.
  • Pregnancy, lactation, or intention to become pregnant during the study period.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07415473 · AKK-IFX-CD-2026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗