Akkermansia Muciniphila Combined With Infliximab for Promoting Intestinal Mucosal Healing in Crohn's Disease
Phase 4 · Testing Infliximab and Akkermansia muciniphila + Infliximab · Sites not listed yet · Chinese Medical Association
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Infliximab (a drug) and Akkermansia muciniphila + Infliximab (a drug) as a possible treatment. Condition(s) listed: Crohn's Diseases.
Participants are assigned to groups by chance (randomized).
It is open-label: participants know what they are receiving.
Phase 4 studies look at treatments that are already approved, to learn more about how they work in everyday use.
Who can join
- Ages 18 to 75
- Any sex
Some of the main requirements, copied from the record:
- 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).
Plus 3 more requirement(s). There are also 6 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 400 participants are expected to take part.
- Start date: 2026-04-01 (planned).
- Main results expected around 2029-03-31 (estimate from the record).
- No study sites are listed yet. Check the official record for contact details.
Main thing being measured
- Complete mucosal healing (From enrollment to the end of treatment at 26 weeks)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Phase 4 |
| Study type | Interventional |
| Conditions | Crohn's Diseases |
| Lead sponsor | Chinese Medical Association |
| Collaborators | First Affiliated Hospital, Sun Yat-Sen University; Sixth Affiliated Hospital, Sun Yat-sen University; Shenzhen University General Hospital |
| Enrollment | 400 (estimated) |
| Start date | 2026-04-01 |
| Primary completion (est.) | 2029-03-31 |
| First posted | 2026-02-17 |
| Last updated | 2026-02-17 |
| 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 |
| ClinicalTrials.gov ID | NCT07415473 |
Interventions
- 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.
Full eligibility criteria (from the record)
Inclusion Criteria: 1. Adult patients aged 18 to 75 years. 2. Documented diagnosis of Crohn's disease established at any time prior to screening by radiological, histological, or endoscopic evidence. 3. Active Crohn's disease at screening, defined as a Crohn's Disease Activity Index (CDAI) score between 220 and 450 (inclusive). 4. 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. 5. Willingness and ability to provide written informed consent. 6. Agreement to undergo all scheduled study procedures, including up to 3 endoscopic evaluations. Exclusion Criteria: 1. Use of any biologic therapy (e.g., infliximab, adalimumab, ustekinumab, vedolizumab) within 8 weeks prior to screening. 2. Use of systemic antibiotics or any probiotic preparation within 4 weeks prior to screening. 3. History of any intestinal resection or other Crohn's disease-related surgery. 4. History of or active chronic or recurrent infectious disease. 5. History of or current malignancy. 6. Pregnancy, lactation, or intention to become pregnant during the study period.
Locations (0)
No sites listed yet. The official record has contact information.
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.