Nutritional support with synbiotics, omega-3, and vitamin D for patients undergoing pancreatic surgery
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.
This study is testing whether adding synbiotics, omega-3, and vitamin D to regular nutrition can help patients recover better after pancreatic surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 74 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Liege Academic / other |
| Locations | 1 site (Liège) |
| Trial ID | NCT05271344 on ClinicalTrials.gov |
What this trial studies
This trial aims to evaluate the effectiveness of a multimodal nutritional approach combining synbiotics, omega-3 fatty acids, and vitamin D in reducing postoperative complications in patients undergoing duodenopancreatectomy for tumoral lesions. Participants will be divided into two groups: one receiving conventional immunonutrition and the other receiving enhanced immunonutrition with additional supplements. The study will assess overall morbidity rates between the two groups to determine the potential benefits of the enhanced regimen. This approach is novel as it combines multiple nutritional interventions that have individual scientific backing but have not been tested together.
Who should consider this trial
Good fit: Ideal candidates are patients scheduled for duodenopancreatectomy due to tumoral lesions.
Not a fit: Patients with conditions such as severe cardiorespiratory insufficiency, unresectable tumors, or those who cannot provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce postoperative complications for patients undergoing pancreatic surgery.
How similar studies have performed: While similar nutritional interventions have shown promise, this specific combination has not been previously tested, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Liège
- Chu — Liège, Belgium (Recruiting)
Study contacts
- Principal investigator: Alain Pans, MD — Centre Hospitalier Universitaire de Liege
- Study coordinator: Alain Pans, MD
- Email: a.pans@chuliege.be
- Phone: 003243667216
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.