Effect of Intestinal Carriage of *Pilosibacter Rotomagensis* on Intestinal Inflammatory Activity
Observational · No treatment assigned · 1 site · University Hospital, Rouen
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Crohn's Diseases. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- Patient aged 18 years or older
- Patient with a history of ileocecal resection for Crohn's disease.
- Patient with isolated ileal Crohn's disease at the time of ileocecal resection surgery.
There are also 5 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 116 participants are expected to take part.
- Start date: 2026-10-01 (planned).
- Main results expected around 2028-10-01 (estimate from the record).
- 1 study site listed in France.
Main thing being measured
- Association between intestinal inflammatory activity and the carriage rInvestigating the aate of *Pilosibacter rotomagensis (1 day)
In the researchers’ words
Crohn's disease is a chronic inflammatory condition that can affect the entire digestive tract. The terminal ileum is the segment most frequently involved, and approximately one-third of patients present with disease limited to the ileum. In such cases, surgical resection to remove all inflammatory lesions may be performed.
Words you might see
- Placebo: a look-alike pill or injection with no active drug, used for comparison.
- Randomized: participants are put into groups by chance, like a coin flip.
- Anti-TNF: a group of biologic medicines (such as infliximab or adalimumab) used in IBD.
- Biologic: a medicine made from living cells, usually given by injection or infusion.
General definitions, not specific to this trial.
This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.
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 | Observational |
| Study type | Observational |
| Conditions | Crohn's Diseases |
| Lead sponsor | University Hospital, Rouen |
| Enrollment | 116 (estimated) |
| Start date | 2026-10-01 |
| Primary completion (est.) | 2028-10-01 |
| First posted | 2026-10-13 |
| Last updated | 2026-10-13 |
| Official title | Effect of Intestinal Carriage of *Pilosibacter Rotomagensis* on Intestinal Inflammatory Activity in the Postoperative Setting of Crohn's Disease. |
| ClinicalTrials.gov ID | NCT07871383 |
Interventions
- Microbiota suspension (Other)
If the patient agrees to participate, the stool sample will be used for both fecal calprotectin analysis (standard care) and the analysis of gut microbiota and short-chain fatty acids (research protocol). The purpose of this stool collection is to address the primary and secondary objectives of the present study.
Full eligibility criteria (from the record)
Inclusion Criteria: * Patient aged 18 years or older * Patient with a history of ileocecal resection for Crohn's disease. * Patient with isolated ileal Crohn's disease at the time of ileocecal resection surgery. Exclusion Criteria: * Refusal to participate in the study. * Presence of residual digestive lesions associated with Crohn's disease (e.g., colonic or perineal involvement) less than one month after ileocecal resection. * Use of antibiotics or non-steroidal anti-inflammatory drugs (NSAIDs) within the 28 days prior to stool collection. * Patients with cancer of the digestive tract. * Pregnant patients.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| University Rouen Hospital | Rouen | France |
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.