Intestinal InflammationDIR-HNCT07022548
Prospective Study Evaluating the Prevalence of Intestinal Dysfunction
An observational study of Intestinal Inflammation, run by University Hospital, Rouen at 1 site in France.
Trial summary
The intestinal tract has multiple functions within the body beyond its primary function of nutrient absorption. It acts as a true barrier protecting the body from living microorganisms and antigens in the intestinal lumen. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intestinal Inflammation
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 13 Nov 2023to 1 Dec 2025
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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: 40 patients with malignant haemopathy admitted for sepsis or septic shock in intensive care and a control population of 40 patients admitted to intensive care for sepsis or septic shock
Who may be able to join
- Population with hematologic malignancy
- Patients over 18 years of age
- Suffering from hematologic malignancy
- Admitted to intensive care for sepsis or septic shock according to sepsis definition 3:
- Sepsis: organ dysfunction (SOFA > or = 2) related to a host response to infection
- Septic shock: sepsis with acute circulatory failure and metabolic abnormalities (serum lactate > 2 mmol/L) and vasopressors
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- Patients who have read and understood the information letter and do not object to participating in the study
- Affiliated with or beneficiary of a social security scheme.
- Control population
- Patient aged over 18
- Admitted to intensive care for sepsis or septic shock according to the sepsis definition 3:
- Sepsis: organ dysfunction (SOFA > or = 2) related to a host response to infection
- Septic shock: sepsis with acute circulatory failure and metabolic abnormalities (serum lactate > 2 mmol/L) and vasopressors
- Patient who has read and understood the information letter and does not object to participating in the study
- Member of or beneficiary of a social security scheme
Who cannot join
- For the control group and those with hematologic malignancies:
- Patient refusal
- Pregnant, parturient, or breastfeeding woman
- Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection/guardianship or curatorship
- Person who does not understand or speak French
- Moribund
- Limitations of active therapies (LATA) established upon admission
- Hospitalization in intensive care > 72 hours
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Study Evaluating the Prevalence of Intestinal Dysfunction in Hematology Patients Hospitalized in Intensive Care for Sepsis or Septic Shock
The intestinal tract has multiple functions within the body beyond its primary function of nutrient absorption. It acts as a true barrier protecting the body from living microorganisms and antigens in the intestinal lumen. Impairment of any component of the intestinal barrier results in nutrient malabsorption, an altered local digestive immune response, and increased intestinal permeability.
The primary function of this barrier is to limit the access of the contents of the intestinal lumen, which particularly includes the bacterial components of the microbiota, to the internal environment and the circulation. This physical barrier function is provided by a monolayer of epithelial cells, closely connected to each other by intercellular junctions (tight junctions, adherens and desmosomes, as well as by the mucus which covers the apical surface of the cells, the constituents of which, mucins, are secreted by the goblet cells. The term intestinal barrier is also used in a broader sense including a protective role against the invasion of environmental pathogens, while allowing toleranSepsis-associated intestinal failure is often underestimated, yet it is found in 20 to 60% of ICU (Intensive Care Unit)vpatients. However, its prognosis is poorly documented. For example, there is no consensus definition of this dysfunction or validated biomarkers for rapid assessment. Consequently, it does not appear in most prognostic scores (SOFA, IGS2, etc.).
Intestinal permeability, a risk factor for bacterial translocation when elevated, is increased in ICU (Intensive Care Unit) patients and associated with multiorgan failure system (MODS), particularly in cases of intestinal fasting. However, there is currently no validated marker of acute intestinal failure in intensive care or intensive care.ce towards commensal flora and foods.
Read the detailed description
Several markers of intestinal response have been studied and are still in the research field due to a lack of conclusive work on their impact.
Clinically, both in post-weaning children and in adults, citrullinemia (citrulline deficiency) is well established as a sensitive and specific indicator of functional absorptive enterocyte mass.
Fecal calprotectin is already used as a marker of neutrophil-mediated inflammation in inflammatory bowel disease.
A recent controlled observational study of 165 patients investigated serum calprotectin as a prognostic marker in sepsis patients hospitalized in critical care. The authors found a significant increase in serum calprotectin concentration in sepsis patients compared to control patients. Furthermore, it would appear that a high level of calprotectin upon admission to intensive care is a significant risk factor for long-term mortality.
Finally, in patients with sepsis, serum zonulin levels are elevated, which promotes bacterial translocation via the epithelium and thus bacteremia.
The risk of infection in immunocompromised patients is a therapeutic challenge due to its adverse prognostic impact. Sepsis-related mortality is higher (relative risk = 1.62) in immunocompromised patients. One of the mechanisms of sepsis in these patients is gastrointestinal bacterial translocation due to the gastrointestinal cytotoxicity of chemotherapy, microbiota alterations via antibiotic therapy, and low perfusion rates.
This study aims to assess the prevalence of intestinal inflammation in a population of patients with malignant hematological diseases undergoing treatment and admitted to intensive care for sepsis-septic shock. These patients are exposed to cytotoxic chemotherapies that attack the intestinal mucosa, making it more permeable and thus being the source of digestive translocations of bacteria from the intestinal microbiota into the bloodstream. In the absence of validated threshold values in the literature to define intestinal inflammation based on fecal calprotectin levels, it is necessary to have a control population also affected by sepsis but not carrying malignant hematological disease.
- Conditions
- Intestinal Inflammation
- Keywords
- sepsis/septic shock, prevalence
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patient admitted to intensive care for sepsis or septic shock with malignant hematological disease | Not described | |
| Patient admitted to intensive care for sepsis or septic shock without malignant hematological diseas | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of intestinal inflammation
To assess the prevalence of intestinal inflammation defined by the fecal calprotectin level on admission (<72 hours) in patients with malignant hematological disease admitted to intensive care for sepsis or septic shock.
Measured: 72 hours after enrollment visit
Secondary outcomes (5)
Prevalence of intestinal hyperpermeability
To assess the prevalence of intestinal hyperpermeability defined by the plasma level of zonulin taken between admission and H72 in patients with malignant haemopathy admitted to intensive care for sepsis or septic shock (compared to the control population also suffering from sepsis but not carrying malignant haemopathy)
Measured: 72 hours after enrollment visit
Prevalence of intestinal hyperpermeability
To assess the prevalence of intestinal hyperpermeability defined by the fecal zonulin level on admission taken between admission and H72 in patients with malignant haemopathy admitted to intensive care for sepsis or septic shock (compared to the control population)
Measured: 72 hours after enrollment visit
Integrity of intestinal tissue
To assess the integrity of intestinal tissue defined by the level of plasma IFABP collected between admission and H72 in patients with malignant haemopathy admitted to intensive care for sepsis or septic shock (compared to the control population)
Measured: 72 hours after enrollment visit
Impact of intestinal dysfunction on the occurrence of digestive intolerance
Assess the impact of intestinal dysfunction on the occurrence of digestive intolerance: vomiting, diarrhea, constipation, occlusive syndrome
Measured: month 6
Impact of intestinal dysfunction on mortality
Evaluation of the impact of intestinal dysfunction on mortality in intensive care and hospitalization
Measured: month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start13 Nov 2023
- Primary completion30 Apr 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal InflammationStudies of the same condition, open and under way.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabienne FT TAMION, Professor, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07022548
- Sponsor's protocol ID
- 2023/060/OB
- Other IDs
- N° IDRCB : 2023-A00552-43
- Acronym
- DIR-H
- Status last verified
- Jan 2025
- First submitted
- 6 Jun 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data provided will be the property of the sponsor and will be used solely for its own research activities.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study Evaluating the Prevalence of Intestinal Dysfunction in Hematology Patients Hospitalized in Intensive Care for Sepsis or Septic Shock
- ClinicalTrials.gov ID
- NCT07022548
- Acronym / sponsor ID
- DIR-H / 2023/060/OB
- Conditions
- Intestinal Inflammation
- Keywords
- sepsis/septic shock, prevalence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 13 Nov 2023 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 15 Jun 2025 (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.
The intestinal tract has multiple functions within the body beyond its primary function of nutrient absorption. It acts as a true barrier protecting the body from living microorganisms and antigens in the intestinal lumen. Impairment of any component of the intestinal barrier results in nutrient malabsorption, an altered local digestive immune response, and increased intestinal permeability.
The primary function of this barrier is to limit the access of the contents of the intestinal lumen, which particularly includes the bacterial components of the microbiota, to the internal environment and the circulation. This physical barrier function is provided by a monolayer of epithelial cells, closely connected to each other by intercellular junctions (tight junctions, adherens and desmosomes, as well as by the mucus which covers the apical surface of the cells, the constituents of which, mucins, are secreted by the goblet cells. The term intestinal barrier is also used in a broader sense including a protective role against the invasion of environmental pathogens, while allowing toleranSepsis-associated intestinal failure is often underestimated, yet it is found in 20 to 60% of ICU (Intensive Care Unit)vpatients. However, its prognosis is poorly documented. For example, there is no consensus definition of this dysfunction or validated biomarkers for rapid assessment. Consequently, it does not appear in most prognostic scores (SOFA, IGS2, etc.).
Intestinal permeability, a risk factor for bacterial translocation when elevated, is increased in ICU (Intensive Care Unit) patients and associated with multiorgan failure system (MODS), particularly in cases of intestinal fasting. However, there is currently no validated marker of acute intestinal failure in intensive care or intensive care.ce towards commensal flora and foods.
Detailed description
Several markers of intestinal response have been studied and are still in the research field due to a lack of conclusive work on their impact.
Clinically, both in post-weaning children and in adults, citrullinemia (citrulline deficiency) is well established as a sensitive and specific indicator of functional absorptive enterocyte mass.
Fecal calprotectin is already used as a marker of neutrophil-mediated inflammation in inflammatory bowel disease.
A recent controlled observational study of 165 patients investigated serum calprotectin as a prognostic marker in sepsis patients hospitalized in critical care. The authors found a significant increase in serum calprotectin concentration in sepsis patients compared to control patients. Furthermore, it would appear that a high level of calprotectin upon admission to intensive care is a significant risk factor for long-term mortality.
Finally, in patients with sepsis, serum zonulin levels are elevated, which promotes bacterial translocation via the epithelium and thus bacteremia.
The risk of infection in immunocompromised patients is a therapeutic challenge due to its adverse prognostic impact. Sepsis-related mortality is higher (relative risk = 1.62) in immunocompromised patients. One of the mechanisms of sepsis in these patients is gastrointestinal bacterial translocation due to the gastrointestinal cytotoxicity of chemotherapy, microbiota alterations via antibiotic therapy, and low perfusion rates.
This study aims to assess the prevalence of intestinal inflammation in a population of patients with malignant hematological diseases undergoing treatment and admitted to intensive care for sepsis-septic shock. These patients are exposed to cytotoxic chemotherapies that attack the intestinal mucosa, making it more permeable and thus being the source of digestive translocations of bacteria from the intestinal microbiota into the bloodstream. In the absence of validated threshold values in the literature to define intestinal inflammation based on fecal calprotectin levels, it is necessary to have a control population also affected by sepsis but not carrying malignant hematological disease.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient admitted to intensive care for sepsis or septic shock with malignant hematological disease | – | – |
| Patient admitted to intensive care for sepsis or septic shock without malignant hematological diseas | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 40 patients with malignant haemopathy admitted for sepsis or septic shock in intensive care and a control population of 40 patients admitted to intensive care for sepsis or septic shock
Key inclusion criteria (15 listed)
- Population with hematologic malignancy
- Patients over 18 years of age
- Suffering from hematologic malignancy
- Admitted to intensive care for sepsis or septic shock according to sepsis definition 3:
- Patients who have read and understood the information letter and do not object to participating in the study
Key exclusion criteria (8 listed)
- Patient refusal
- Pregnant, parturient, or breastfeeding woman
- Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection/guardianship or curatorship
- Person who does not understand or speak French
- Moribund
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of intestinal inflammation
Time frame: 72 hours after enrollment visit
To assess the prevalence of intestinal inflammation defined by the fecal calprotectin level on admission (<72 hours) in patients with malignant hematological disease admitted to intensive care for sepsis or septic shock.
5 secondary outcomes
Prevalence of intestinal hyperpermeability
Time frame: 72 hours after enrollment visit
Prevalence of intestinal hyperpermeability
Time frame: 72 hours after enrollment visit
Integrity of intestinal tissue
Time frame: 72 hours after enrollment visit
Impact of intestinal dysfunction on the occurrence of digestive intolerance
Time frame: month 6
Impact of intestinal dysfunction on mortality
Time frame: month 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: No. The data provided will be the property of the sponsor and will be used solely for its own research activities.
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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. This study is not recruiting at the moment.
Fabienne FT TAMION, Professor principal investigator
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 Intestinal Inflammation, 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 15 inclusion and 8 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: finished, as of the sponsor's last update on 21 Jan 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of intestinal inflammation (time frame: 72 hours after enrollment visit). 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 21 Jan 2026; AzTrials last refreshed its copy on 28 Oct 2026.