Crohn's DiseasesProsPecNCT07871383
Effect of Intestinal Carriage of *Pilosibacter Rotomagensis* on Intestinal Inflammatory Activity
An observational study of Crohn's Diseases, run by University Hospital, Rouen at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Diseases
- What is being tested?
- Microbiota suspension
- How many people
- 116 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2026to 30 Oct 2028
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with a history of ileocecal resection for Crohn's disease.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
University Rouen Hospital
Rouen, 76031
Nicolas NR RICHARD, Doctor, 02 32 88 67 07 ext. +33, Nicolas.Richard@chu-rouen.fr
About this study
Official title: Effect of Intestinal Carriage of *Pilosibacter Rotomagensis* on Intestinal Inflammatory Activity in the Postoperative Setting of Crohn's Disease.
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. This procedure prevents recurrence in about 50% of patients within five years of surgery.
The post-operative setting offers a prime opportunity to study the early pathophysiological stages of Crohn's disease and the risk factors for recurrence. While smoking is a well-established risk factor for recurrence, the role of other factors-such as a fistulizing phenotype or a history of small-bowel resection-remains a subject of debate. Meanwhile, the role of the gut microbiota in this process remains largely unclear. Currently, the prevention of post-operative recurrence relies exclusively on smoking cessation and biologic therapies. However, the efficacy of these biologics-particularly anti-TNFα (Tumor Necrosis Factor alpha) agents-is reduced in patients who received prior treatment with these drugs before surgery. Notably, the proportion of such pre-treated patients has risen over the last two decades, reaching 50%. Consequently, there is a need to expand the range of strategies available to prevent post-operative recurrence. A better understanding of host-gut bacteria interactions could help prevent postoperative recurrence. To date, only *Faecalibacterium prausnitzii* and Adherent-Invasive *Escherichia coli* (AIEC) have been associated with a lower and higher risk of postoperative recurrence, respectively. However, a randomized controlled trial showed that antibiotic treatment aimed at eradicating AIEC was no more effective than a placebo in Crohn's disease. These trial results reinforce the value of a strategy based on identifying anti-inflammatory bacterial species that may play a protective role against postoperative recurrence.
Read more
*Pilosibacter rotomagensis* is a bacterial species recently isolated from humans by the INSERM U1073 team; it may play a key role in intestinal physiology. This species is distinguished by its high capacity to produce short-chain fatty acids-particularly butyrate-and by anti-inflammatory properties observed in various *in vitro* cellular models.
The hypothesis of this project is that carriage of *Pilosibacter rotomagensis* could play a protective role against postoperative recurrence in ileal Crohn's disease.
Read the detailed description
To explore this hypothesis, we will conduct a single-center, cross-sectional study investigating the association between *Pilosibacter rotomagensis* carriage and intestinal inflammatory activity following resection for isolated ileal Crohn's disease. Crohn's disease inflammatory activity will be assessed by measuring fecal calprotectin, a non-invasive inflammatory marker specific to intestinal inflammation that is used in routine clinical practice. Disease recurrence will be defined as the occurrence of any of the following events during the postoperative period: (1) endoscopic recurrence (defined by a Rutgeerts score ≥ 2); (2) a new surgical procedure related to Crohn's disease; or (3) the initiation or modification of biologic therapy at least 6 months after ileocecal resection. Furthermore, given the cross-sectional nature of the study, it would be difficult to establish a causal relationship-whether cause or consequence-between recurrence and bacterial carriage. Therefore, the association with inflammatory activity (fecal calprotectin) in the postoperative setting will be analyzed while adjusting for the following clinical parameters: smoking status at the time of sampling (non-smoker, former smoker, current smoker), complicated phenotype (defined as a history of fistulizing or stenosing complications during the course of Crohn's disease), and the time elapsed since surgery. The expected benefit of this study is to establish an initial clinical rationale regarding the role of this bacterium in the process of postoperative recurrence of Crohn's disease, by examining intestinal inflammation and its marker, fecal calprotectin. Consequently, this study could justify a multicenter, longitudinal, observational research protocol to investigate postoperative carriage of *Pilosibacter rotomagensis* and longitudinally track clinical recurrences of Crohn's disease. The ultimate goal of this line of research would be to pave the way for interventional studies aimed at preventing postoperative recurrence through oral supplementation with this bacterium. Finally, this study is part of a cross-disciplinary initiative to translate preclinical discoveries made by a research unit at the University of Rouen-a partner of the University Hospital-into clinical application.
- Conditions
- Crohn's Diseases
- Being tested
- Microbiota suspension
- Keywords
- Pilosibacter rotomagensis, intestinal inflammatory activity
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microbiota suspensionOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between intestinal inflammatory activity and the carriage rInvestigating the aate of *Pilosibacter rotomagensis
Investigating the association between intestinal inflammatory activity and the carriage rate of *Pilosibacter rotomagensis following resection for isolated ileal Crohn's disease by measuring fecal calprotectin levels
Measured: 1 day
Secondary outcomes (13)
Association between intestinal inflammatory activity and the relative abundance of Pilosibacter rotomagensis
Investigate the association between intestinal inflammatory activity and the relative abundance of Pilosibacter rotomagensis within the microbiota following resection for isolated ileal Crohn's disease by assessing the abundance of Pilosibacter rotomagensis in stool samples
Measured: 1 day
Association between fecal carriage of Pilosibacter rotomagensis and clinical recurrence of Crohn's disease
Investigation of the association between fecal carriage of *Pilosibacter rotomagensis* and clinical recurrence of Crohn's disease following resection for isolated ileal Crohn's disease by determining the number of clinical recurrences of Crohn's disease
Measured: 1 day
Association between intestinal inflammatory activity and fecal short-chain fatty acid abundance
Investigation of the association between intestinal inflammatory activity and fecal short-chain fatty acid abundance following resection for isolated ileal Crohn's disease by assessing the abundance of short-chain fatty acids in the stool.
Measured: 1 day
Association between intestinal inflammatory activity and the relative abundance of F. prausnitzii in the microbiota
Investigation of the association between intestinal inflammatory activity and the relative abundance of F. prausnitzii in the microbiota following resection for isolated ileal Crohn's disease by Evaluation of the abundance of F. prausnitzii in stool
Measured: 1 day
Association between intestinal inflammatory activity and the relative abundance of AIEC within the microbiota
Investigation of the association between intestinal inflammatory activity and the relative abundance of AIEC within the microbiota following resection for isolated ileal Crohn's disease by measuring the abundance of AIEC in the stool. AIEC stands for Adherent-Invasive Escherichia coli.
Measured: 1 day
Association between intestinal inflammatory activity and the diversity of bacterial taxa constituting the gut microbiota.
Investigation of the association between intestinal inflammatory activity and the diversity of bacterial taxa constituting the gut microbiota by evaluating alpha-diversity indices (observed richness,)
Measured: 1 day
Association between intestinal inflammatory activity and the diversity of bacterial taxa constituting the gut microbiota.
Investigation of the association between intestinal inflammatory activity and the diversity of bacterial taxa constituting the gut microbiota by evaluating Beta-diversity indices (Bray-Curtis dissimilarity index and Jaccard distance)
Measured: 1 day
Association between intestinal inflammatory activity and the taxonomic composition of the gut microbiota.
Investigation of the association between intestinal inflammatory activity and the taxonomic composition of the gut microbiota.by evaluating the relative abundance of the bacterial taxa making up the gut microbiota.
Measured: 1 day
Association between intestinal inflammatory activity and the diversity of bacterial taxa constituting the gut microbiota.
Investigation of the association between intestinal inflammatory activity and the diversity of bacterial taxa constituting the gut microbiota by evaluating alpha-diversity indices (Simpson Indice). The Simpson index is a measure of gut microbiota diversity. It therefore takes into account two elements:
- richness: how many bacterial taxa are present;
- evenness: how abundances are distributed among these taxa (in %).
Measured: 1 day
Association between intestinal inflammatory activity and the diversity of bacterial taxa constituting the gut microbiota.
Investigation of the association between intestinal inflammatory activity and the diversity of bacterial taxa constituting the gut microbiota by evaluating alpha-diversity indices (Shannon indice). The Shannon index is an alpha-diversity index used to measure gut microbiota diversity. It specifies how many types of bacteria are present and the extent to which their abundances are balanced (In %)
Measured: 1 day
Association between intestinal inflammatory activity and the diversity of bacterial taxa constituting the gut microbiota.
Investigation of the association between intestinal inflammatory activity and the diversity of bacterial taxa constituting the gut microbiota by evaluating alpha-diversity indices (Pielou indice). Pielou's index measures the evenness of a microbiota.It makes it possible to determine whether the various bacterial species are present in relatively balanced proportions. Pielou's index is calculated from the Shannon index:
J = H' / log(S) where: H' = Shannon index; S = number of observed taxa (richness).
The value generally ranges from 0 to 1:
1 → all species are present in equal proportions; close to 0 → one or a few species are strongly dominant.
Measured: 1 day
Association between intestinal inflammatory activity and the diversity of bacterial taxa constituting the gut microbiota.
Investigation of the association between intestinal inflammatory activity and the diversity of bacterial taxa constituting the gut microbiota by evaluating the beta-diversity index (Bray-Curtis dissimilarity index). Bray-Curtis is an index that measures the difference in composition between two microbiota. The two microbiota are identical → Bray-Curtis = 0. The microbiota are completely different → Bray-Curtis = 1.
Measured: 1 day
Association between intestinal inflammatory activity and the diversity of bacterial taxa constituting the gut microbiota.
Investigation of the association between intestinal inflammatory activity and the diversity of bacterial taxa constituting the gut microbiota by evaluating the beta-diversity index (Jaccard distance index). The Jaccard distance index is a measure of beta-diversity; it is used to compare the composition of two microbiota. The Jaccard distance generally ranges from 0 to 1:
0 → the two microbiota share the same taxa;
1 → no taxa in common.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2028 (estimated)
- Study completion30 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 116 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas NR RICHARD, Doctor, Study director, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07871383
- Sponsor's protocol ID
- 2026/0202/OB
- Other IDs
- 2026-A01241-50
- Acronym
- ProsPec
- Status last verified
- Sep 2026
- First submitted
- 30 Sep 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- ProsPec / 2026/0202/OB
- Conditions
- Crohn's Diseases
- Keywords
- Pilosibacter rotomagensis, intestinal inflammatory activity
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 30 Oct 2028 (estimated)
- First posted
- 13 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. This procedure prevents recurrence in about 50% of patients within five years of surgery.
The post-operative setting offers a prime opportunity to study the early pathophysiological stages of Crohn's disease and the risk factors for recurrence. While smoking is a well-established risk factor for recurrence, the role of other factors-such as a fistulizing phenotype or a history of small-bowel resection-remains a subject of debate. Meanwhile, the role of the gut microbiota in this process remains largely unclear. Currently, the prevention of post-operative recurrence relies exclusively on smoking cessation and biologic therapies. However, the efficacy of these biologics-particularly anti-TNFα (Tumor Necrosis Factor alpha) agents-is reduced in patients who received prior treatment with these drugs before surgery. Notably, the proportion of such pre-treated patients has risen over the last two decades, reaching 50%. Consequently, there is a need to expand the range of strategies available to prevent post-operative recurrence. A better understanding of host-gut bacteria interactions could help prevent postoperative recurrence. To date, only *Faecalibacterium prausnitzii* and Adherent-Invasive *Escherichia coli* (AIEC) have been associated with a lower and higher risk of postoperative recurrence, respectively. However, a randomized controlled trial showed that antibiotic treatment aimed at eradicating AIEC was no more effective than a placebo in Crohn's disease. These trial results reinforce the value of a strategy based on identifying anti-inflammatory bacterial species that may play a protective role against postoperative recurrence.
*Pilosibacter rotomagensis* is a bacterial species recently isolated from humans by the INSERM U1073 team; it may play a key role in intestinal physiology. This species is distinguished by its high capacity to produce short-chain fatty acids-particularly butyrate-and by anti-inflammatory properties observed in various *in vitro* cellular models.
The hypothesis of this project is that carriage of *Pilosibacter rotomagensis* could play a protective role against postoperative recurrence in ileal Crohn's disease.
Detailed description
To explore this hypothesis, we will conduct a single-center, cross-sectional study investigating the association between *Pilosibacter rotomagensis* carriage and intestinal inflammatory activity following resection for isolated ileal Crohn's disease. Crohn's disease inflammatory activity will be assessed by measuring fecal calprotectin, a non-invasive inflammatory marker specific to intestinal inflammation that is used in routine clinical practice. Disease recurrence will be defined as the occurrence of any of the following events during the postoperative period: (1) endoscopic recurrence (defined by a Rutgeerts score ≥ 2); (2) a new surgical procedure related to Crohn's disease; or (3) the initiation or modification of biologic therapy at least 6 months after ileocecal resection. Furthermore, given the cross-sectional nature of the study, it would be difficult to establish a causal relationship-whether cause or consequence-between recurrence and bacterial carriage. Therefore, the association with inflammatory activity (fecal calprotectin) in the postoperative setting will be analyzed while adjusting for the following clinical parameters: smoking status at the time of sampling (non-smoker, former smoker, current smoker), complicated phenotype (defined as a history of fistulizing or stenosing complications during the course of Crohn's disease), and the time elapsed since surgery. The expected benefit of this study is to establish an initial clinical rationale regarding the role of this bacterium in the process of postoperative recurrence of Crohn's disease, by examining intestinal inflammation and its marker, fecal calprotectin. Consequently, this study could justify a multicenter, longitudinal, observational research protocol to investigate postoperative carriage of *Pilosibacter rotomagensis* and longitudinally track clinical recurrences of Crohn's disease. The ultimate goal of this line of research would be to pave the way for interventional studies aimed at preventing postoperative recurrence through oral supplementation with this bacterium. Finally, this study is part of a cross-disciplinary initiative to translate preclinical discoveries made by a research unit at the University of Rouen-a partner of the University Hospital-into clinical application.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with a history of ileocecal resection for Crohn's disease.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microbiota suspensionIf 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. | Other | – |
Primary outcome
Association between intestinal inflammatory activity and the carriage rInvestigating the aate of *Pilosibacter rotomagensis
Time frame: 1 day
Investigating the association between intestinal inflammatory activity and the carriage rate of *Pilosibacter rotomagensis following resection for isolated ileal Crohn's disease by measuring fecal calprotectin levels
13 secondary outcomes
Association between intestinal inflammatory activity and the relative abundance of Pilosibacter rotomagensis
Time frame: 1 day
Association between fecal carriage of Pilosibacter rotomagensis and clinical recurrence of Crohn's disease
Time frame: 1 day
Association between intestinal inflammatory activity and fecal short-chain fatty acid abundance
Time frame: 1 day
Association between intestinal inflammatory activity and the relative abundance of F. prausnitzii in the microbiota
Time frame: 1 day
Association between intestinal inflammatory activity and the relative abundance of AIEC within the microbiota
Time frame: 1 day
Association between intestinal inflammatory activity and the diversity of bacterial taxa constituting the gut microbiota.
Time frame: 1 day
Association between intestinal inflammatory activity and the diversity of bacterial taxa constituting the gut microbiota.
Time frame: 1 day
Association between intestinal inflammatory activity and the taxonomic composition of the gut microbiota.
Time frame: 1 day
Association between intestinal inflammatory activity and the diversity of bacterial taxa constituting the gut microbiota.
Time frame: 1 day
Association between intestinal inflammatory activity and the diversity of bacterial taxa constituting the gut microbiota.
Time frame: 1 day
Association between intestinal inflammatory activity and the diversity of bacterial taxa constituting the gut microbiota.
Time frame: 1 day
Association between intestinal inflammatory activity and the diversity of bacterial taxa constituting the gut microbiota.
Time frame: 1 day
Association between intestinal inflammatory activity and the diversity of bacterial taxa constituting the gut microbiota.
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nicolas NR RICHARD, Doctor study director
University Hospital, Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn's Diseases, run by University Hospital, Rouen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nabila NL LAAJAIL, Director (02 32 88 82 65 ext. +33, Nabila.Laajail@chu-rouen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between intestinal inflammatory activity and the carriage rInvestigating the aate of *Pilosibacter rotomagensis (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.