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NCT Number: NCT07415473

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

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.

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Key information

Conditions

Crohn's Diseases Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Infliximab

Drug

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.

Akkermansia muciniphila + Infliximab

Drug

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 outcomes

  1. Complete mucosal healing

    Time frame: From enrollment to the end of treatment at 26 weeks

    Complete mucosal healing is defined as the absence of ulceration, as determined by ileocolonoscopic examination.

Secondary outcomes

  1. Endoscopic remission

    Time frame: From enrollment to the end of treatment at 26 weeks

    Endoscopic remission is defined as a simple endoscopic score for Crohn's Disease (SES-CD) score of ≤4. The SES-CD evaluates 4 endoscopic variables-ulcer size, proportion of the surface area that is ulcerated, proportion of the surface area affected, and stenosis-in 5 segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The score for each endoscopic variable is the sum of values obtained for each segment. The SES-CD total is the sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease.

  2. Endoscopic response

    Time frame: From enrollment to the end of treatment at 26 weeks

    Endoscopic response is defined as a reduction in SES-CD from Baseline by ≥50%.

  3. Clinical remission

    Time frame: From enrollment to the end of treatment at 26 weeks

    Clinical remission is defined as Crohn's Disease Activity Index (CDAI) of ≤150 points. CDAI is a scoring system for the assessment of Crohn's Disease Activity, index values of 150 and below are associated with quiescent disease; values above that indicate active disease and values above 450 are seen with extremely severe disease.

  4. Clinical response

    Time frame: From enrollment to the end of treatment at 26 weeks

    Clinical response is defined as CDAI decrease from Baseline of ≥100 points.

Sponsors and collaborators

Lead sponsor

Chinese Medical Association

Network

Collaborators

  • First Affiliated Hospital, Sun Yat-Sen University
  • Shenzhen University General Hospital
  • Sixth Affiliated Hospital, Sun Yat-sen University

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Feb 17, 2026
Registry last updated
Feb 17, 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.

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