| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Crohn Disease | Other: Standard of Care Dietary Supplement: Immunonutrition | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 350 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | Effect of Peri-operative Immunonutrition on Recurrence and Infections in Crohn's Disease Patients |
| Estimated Study Start Date : | March 1, 2020 |
| Estimated Primary Completion Date : | March 1, 2022 |
| Estimated Study Completion Date : | October 1, 2022 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Standard of Care
Standard of Care is represented by the best standard peri-operative treatment already planned for the study population: as for ERAS guidelines, it is represented by fast restoration of liquid and solid diet after surgery (approximately 24 hours after surgery) and pre-operative and post-operative dietary counselling whenever indicated by the surgeon or gastroenterologist
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Other: Standard of Care
Standard of Care is represented by the best standard peri-operative treatment already planned for the study population: as for ERAS guidelines, it is represented by fast restoration of liquid and solid diet after surgery (approximately 24 hours after surgery) and pre-operative and post-operative dietary counselling whenever indicated by the surgeon or gastroenterologist
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Experimental: Immunonutrition
Impact
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Dietary Supplement: Immunonutrition
Impact. Patients will be asked to consume 3 cartons/day of Nestle IMPACT for pre-operative 7 days and 1 carton/day of Nestle IMPACT for post-operative 30 days
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
| Contact: Annalisa Maroli, PhD | +390282247776 | annalisa.maroli@humanitas.it | |
| Contact: Lara Monti, MS | +390282244623 | lara.monti@humanitas.it |
| Principal Investigator: | Antonino Spinelli, MD, PhD | Istituto Clinico Humanitas |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | July 8, 2019 | ||||||||
| First Posted Date ICMJE | July 10, 2019 | ||||||||
| Last Update Posted Date | November 27, 2019 | ||||||||
| Estimated Study Start Date ICMJE | March 1, 2020 | ||||||||
| Estimated Primary Completion Date | March 1, 2022 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Effect of Peri-operative Immunonutrition on Recurrence and Infections in Crohn's Disease Patients | ||||||||
| Official Title ICMJE | Effect of Peri-operative Immunonutrition on Recurrence and Infections in Crohn's Disease Patients | ||||||||
| Brief Summary | This is an interventional randomized ope-label two-arm trial on the peri-operative use of immunonutrition in Crohn's Disease (CD) patients undergoing colorectal elective surgery.The aim of the trial is to assess the effectiveness of immunonutrition therapy in decreasing the rate of post-operative infective complications and 6 months endoscopic disease recurrence. | ||||||||
| Detailed Description | Crohn's Disease (CD) patients undergoing abdominal surgery are at high risk to develop post-operative surgical and medical infective complications. Infective complications affect almost 24% of patients. Post-surgical disease recurrence afflicts 35-85% of CD patients in the first year after surgery. Immunonutrition has been successfully applied to surgical patients in several randomized trials, demonstrating a decreased rate of post-operative infective complications. The aim of the study is to compare the incidence of surgical and medical post-operative infective complications and six months endoscopic and clinical disease recurrence (DR) in CD patients receiving immunonutrition in the peri-operative setting compared to patients treated as for standard of care. | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Prevention |
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| Condition ICMJE | Crohn Disease | ||||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE |
350 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | October 1, 2022 | ||||||||
| Estimated Primary Completion Date | March 1, 2022 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Not Provided | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT04014517 | ||||||||
| Other Study ID Numbers ICMJE | 2019-001 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Istituto Clinico Humanitas | ||||||||
| Study Sponsor ICMJE | Istituto Clinico Humanitas | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| PRS Account | Istituto Clinico Humanitas | ||||||||
| Verification Date | November 2019 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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