Clinical trial · Interventional
Oral Immunonutrition With Synbiotics, Omega 3 and Vitamin D in Patients Undergoing Duodenopancreatectomy for Tumoral Lesion.
Standard Preoperative Oral Immunonutrition Versus Oral Immunonutrition With Synbiotics, Sustained Omega 3 Impregnation and Vitamin D in Patients Undergoing Duodenopancreatectomy for Tumoral Lesion : a Prospective, Placebo-controlled, Double-blind, Randomized Clinical Trial. The SIO3D Study.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this trial is to demonstrate that synbioimmunonutrition (SI) combined with omega-3 fatty acids (O3) and Vitamin D (D) is superior to conventional 7-day preoperative immunonutrition in terms of reducing overall morbidity, in cases of duodenopancreatectomy for tumoral lesion.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Complication,Postoperative | — | UNRESOLVED | — |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nutritional Products | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Placebo Group
- description
- Placebo products for probiotics, prebiotics, omega 3 and vitamin D
- interventionNames
- Dietary Supplement: Nutritional Products
- type
- EXPERIMENTAL
- label
- Treated Group
- description
- Omega 3 fatty acids for 7 days (before starting conventional oral immunonutrition supplement), Probiotics for 14 days before and after the operation, Prebiotics for 14 days before and after the operation, Vitamin D for 6 days before the operation.
- interventionNames
- Dietary Supplement: Nutritional Products
Primary outcomes (1)
- measure
- Calculation of the Comprehensive Complication Index (CCI)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * All cases of duodenopancreatectomy for tumoral lesions. Exclusion Criteria: * Distal or total pancreatectomies, as well as procedures for chronic pancreatitis * Patient refusal or inability to provide informed consent * Use of dietary supplements containing omega 3, pre- or probiotics within 15 days prior to protocol initiation * Severe cardiorespiratory or renal insufficiency * HIV * Cirrhosis Child-Pugh B-C * Inability to feed by mouth * Intestinal obstruction * Unresectable tumor or metastatic disease on preoperative work-up * Cardiac valvular pathology * Short bowell syndrome * Haemophilia * Known allergy or intolerance to fish oil, fish or shellfish, milk, soy or components of the products used * BMI \< 16kg/m2 * Weight loss \> 15% in the last 6 months * Little or no food in the last 10 days * Hypercalcemia * Pregnancy, breastfeeding
References
Publications (1)
- BACKGROUNDJablonska B, Mrowiec S. The Role of Immunonutrition in Patients Undergoing Pancreaticoduodenectomy. Nutrients. 2020 Aug 23;12(9):2547. doi: 10.3390/nu12092547. PMID 32842475