Intestinal FailureINT-FAILNCT06777251
Changing the Future of Intestinal Failure in Intestinal Chronic Inflammation (INT-FAIL)
A study testing analysis of predictive factors of IF in patients with Crohn's disease through the characterization of "multiomics" parameters in people with Intestinal Failure and Inflammatory Bowel Diseases, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
This is an interventional, prospective, no profit study that will be performed at CEMAD, from FONDAZIONE POLICLINICO GEMELLI IRCCS, Rome (UO1) and U.O.C. Internal Medicine and Gastroenterology from Ospedale Brotzu di Cagliari (UO4). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Intestinal Failure, Inflammatory Bowel Diseases, Crohn Disease
- What is being tested?
- analysis of predictive factors of IF in patients with Crohn's disease through the characterization of "multiomics" parameters
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 254 participants
- Where
- 1 siteItaly
- Study dates
- 29 Feb 2024to 18 May 2025
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years-old and ≤ 75 years old
- Capable of expressing informed consent;
- An established diagnosis of Crohn's disease;
- Antibiotics treatment free for at least 15 days.
Who cannot join
- Age < 18 years-old and > 75 years old;
- Not capable of expressing informed consent;
- Pregnant or breastfeeding patients;
- Comorbidities including: cancer pathology present or under active treatment; coagulopathies; chronic hepatopathy, heart failure, renal failure, respiratory failure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Changing the Future of Intestinal Failure in Intestinal Chronic Inflammation: Towards Innovative Predictive Factors and Therapeutic Targets.
This is an interventional, prospective, no profit study that will be performed at CEMAD, from FONDAZIONE POLICLINICO GEMELLI IRCCS, Rome (UO1) and U.O.C. Internal Medicine and Gastroenterology from Ospedale Brotzu di Cagliari (UO4). Adult patients with Crohn Disease (CD) and chronic intestinal insufficiency (CF) and adult patients with CD at high and low risk of CF.
Read the detailed description
The study involves an initial evaluation in which faecal samples will be collected, a blood sample will be taken and an ileocolonoscopy with biopsy (additional biopsy collection at the same time as clinical practice biopsy for study-specific analysis) will be performed.
Patients will then be re-evaluated nine months after the initial evaluation. In particular, faecal, blood and additional biopsy samples will be collected at the same time as the clinical practice biopsy and any changes in treatment will be recorded.
- Being tested
- analysis of predictive factors of IF in patients with Crohn's disease through the characterization of "multiomics" parameters
- Medical subject headings
- Intestinal Failure, Inflammatory Bowel Diseases, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
analysis of predictive factors of IF in patients with Crohn's disease through the characterization of "multiomics" parametersOther
The study includes an initial evaluation in which faecal samples will be collected, a blood sample will be taken and an ileocolonoscopy with biopsies will be performed (additional biopsy in conjunction with a biopsy from clinical practice for study-specific analyses).
Patients will then be reevaluated nine months after the initial evaluation. In particular, fecal, blood and additional biopsy samples will be collected in conjunction with clinical practice biopsy and all treatment modifications will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| Investigation of predictive factors in patients with intestinal failure in crohn disease | Other | * Typing of gut microbiota, metabolome and immunological signatures (IL 1b family and GLP-2 as starting point) in patients with CD and SBS/IF and in two cohorts of patients with CD, respectively at low and high risk of SBS /IF.
* Combining data from gut microbiota, metabolome and immunological analysis using tools based on Artificial Intelligence (AI) and Machine Learning (ML) technologies.
* Creation of a stool Biobank of categories of patients with Crohn's disease at high risk of SBS/IF and of patients with SBS with or without clinical symptoms of IF. Receives: Other: analysis of predictive factors of IF in patients with Crohn's disease through the characterization of "multiomics" parameters |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive Factors for FH in Crohn's Disease Using Gut Microbiota Composition
This section focuses on characterizing the gut microbiota composition in patients with Crohn's disease at risk of SBS/IF. Advanced sequencing technologies and bioinformatics tools will be used to analyze the relative abundance of microbial species associated with SBS/IF risks.
Unit of Measure: percentage or relative abundance of microbial taxa. Objective: To identify microbiota profiles predictive of dysbiosis and their association with SBS/IF risk factors.
Measured: 24 month
Predictive Factors for FH in Crohn's Disease Using Metabolome Analysis
This section emphasizes the analysis of metabolic profiles. Key metabolites associated with SBS/IF risk will be quantified using mass spectrometry and other advanced chemical analysis techniques.
Unit of Measure: metabolite concentration (e.g., µM, mM). Objective: To understand how metabolic variations influence the development of SBS/IF and support the design of targeted nutritional interventions.
Measured: 24 month
Predictive Factors for FH in Crohn's Disease Using Immunological Signature Characterization
This section investigates the characterization of immunological biomarkers. Specific levels of the IL-1β family and GLP-2 will be measured as indicators of immune response and intestinal repair mechanisms.
Unit of Measure: concentration (pg/mL). Objective: To identify immunological signatures associated with an increased risk of SBS/IF and optimize biomarker-based therapeutic strategies.
Measured: 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start29 Feb 2024
- Primary completion28 Feb 2025
- Study completion18 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal FailureStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 254 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Papa Alfredo, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Alfredo Papa, MD, Principal investigator, Fondazione Policlinico A. Gemelli IRCCS, Rome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06777251
- Sponsor's protocol ID
- 5483
- Acronym
- INT-FAIL
- Status last verified
- Mar 2025
- First submitted
- 14 Mar 2023
- Last updated
- 21 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changing the Future of Intestinal Failure in Intestinal Chronic Inflammation: Towards Innovative Predictive Factors and Therapeutic Targets.
- ClinicalTrials.gov ID
- NCT06777251
- Acronym / sponsor ID
- INT-FAIL / 5483
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 254 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 29 Feb 2024 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 18 May 2025 (estimated)
- First posted
- 15 Jan 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.
This is an interventional, prospective, no profit study that will be performed at CEMAD, from FONDAZIONE POLICLINICO GEMELLI IRCCS, Rome (UO1) and U.O.C. Internal Medicine and Gastroenterology from Ospedale Brotzu di Cagliari (UO4). Adult patients with Crohn Disease (CD) and chronic intestinal insufficiency (CF) and adult patients with CD at high and low risk of CF.
Detailed description
The study involves an initial evaluation in which faecal samples will be collected, a blood sample will be taken and an ileocolonoscopy with biopsy (additional biopsy collection at the same time as clinical practice biopsy for study-specific analysis) will be performed.
Patients will then be re-evaluated nine months after the initial evaluation. In particular, faecal, blood and additional biopsy samples will be collected at the same time as the clinical practice biopsy and any changes in treatment will be recorded.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Investigation of predictive factors in patients with intestinal failure in crohn disease | Other | Other: analysis of predictive factors of IF in patients with Crohn's disease through the characterization of "multiomics" parameters* Typing of gut microbiota, metabolome and immunological signatures (IL 1b family and GLP-2 as starting point) in patients with CD and SBS/IF and in two cohorts of patients with CD, respectively at low and high risk of SBS /IF. * Combining data from gut microbiota, metabolome and immunological analysis using tools based on Artificial Intelligence (AI) and Machine Learning (ML) technologies. * Creation of a stool Biobank of categories of patients with Crohn's disease at high risk of SBS/IF and of patients with SBS with or without clinical symptoms of IF. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years-old and ≤ 75 years old
- Capable of expressing informed consent;
- An established diagnosis of Crohn's disease;
- Antibiotics treatment free for at least 15 days.
Key exclusion criteria (4 listed)
- Age < 18 years-old and > 75 years old;
- Not capable of expressing informed consent;
- Pregnant or breastfeeding patients;
- Comorbidities including: cancer pathology present or under active treatment; coagulopathies; chronic hepatopathy, heart failure, renal failure, respiratory failure.
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 |
|---|---|---|
| analysis of predictive factors of IF in patients with Crohn's disease through the characterization of "multiomics" parametersThe study includes an initial evaluation in which faecal samples will be collected, a blood sample will be taken and an ileocolonoscopy with biopsies will be performed (additional biopsy in conjunction with a biopsy from clinical practice for study-specific analyses). Patients will then be reevaluated nine months after the initial evaluation. In particular, fecal, blood and additional biopsy samples will be collected in conjunction with clinical practice biopsy and all treatment modifications will be recorded. | Other | Investigation of predictive factors in patients with intestinal failure in crohn disease |
Primary outcome
Predictive Factors for FH in Crohn's Disease Using Gut Microbiota Composition
Time frame: 24 month
This section focuses on characterizing the gut microbiota composition in patients with Crohn's disease at risk of SBS/IF. Advanced sequencing technologies and bioinformatics tools will be used to analyze the relative abundance of microbial species associated with SBS/IF risks. Unit of Measure: percentage or relative abundance of microbial taxa. Objective: To identify microbiota profiles predictive of dysbiosis and their association with SBS/IF risk factors.
Predictive Factors for FH in Crohn's Disease Using Metabolome Analysis
Time frame: 24 month
This section emphasizes the analysis of metabolic profiles. Key metabolites associated with SBS/IF risk will be quantified using mass spectrometry and other advanced chemical analysis techniques. Unit of Measure: metabolite concentration (e.g., µM, mM). Objective: To understand how metabolic variations influence the development of SBS/IF and support the design of targeted nutritional interventions.
Predictive Factors for FH in Crohn's Disease Using Immunological Signature Characterization
Time frame: 24 month
This section investigates the characterization of immunological biomarkers. Specific levels of the IL-1β family and GLP-2 will be measured as indicators of immune response and intestinal repair mechanisms. Unit of Measure: concentration (pg/mL). Objective: To identify immunological signatures associated with an increased risk of SBS/IF and optimize biomarker-based therapeutic strategies.
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 21 Mar 2025.
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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.
Alfredo Papa, MD principal investigator
Fondazione Policlinico A. Gemelli IRCCS, Rome
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing analysis of predictive factors of IF in patients with Crohn's disease through the characterization of "multiomics" parameters in people with Intestinal Failure and Inflammatory Bowel Diseases, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 4 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 21 Mar 2025. 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 Italy. 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?
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?
Predictive Factors for FH in Crohn's Disease Using Gut Microbiota Composition (time frame: 24 month). The study lists 3 primary outcomes in all. 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 Mar 2025.