RecruitingNot ApplicableNCT05271344

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.


Sponsor

Centre Hospitalier Universitaire de Liege

Enrollment

74 participants

Start Date

Apr 8, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether taking a nutritional supplement containing synbiotics (probiotics + prebiotics), omega-3 fish oil, and vitamin D before and after surgery to remove part of the pancreas and duodenum (Whipple procedure) improves recovery and reduces complications. **You may be eligible if...** - You are scheduled for a Whipple procedure (duodenopancreatectomy) for a tumor - You are otherwise healthy enough for this major surgery **You may NOT be eligible if...** - Your surgery involves a different type of pancreatectomy (e.g., distal or total) - You have serious heart, lung, or kidney problems - You have HIV or advanced liver cirrhosis - You are unable to eat by mouth - Your tumor is unresectable or has spread to other organs - You have a known allergy to fish oil, fish, shellfish, milk, or soy - Your BMI is below 16, or you have lost more than 15% of your body weight recently - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTNutritional Products

Omega 3 : 1 softgel, 3 x/d Probiotics : 1 caps / d Prebiotics : 1 measuring spoon of powder to be diluted in water, 1x/d Vitamin D : 1 tablet, 2x/d


Locations(1)

CHU

Liège, Belgium

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NCT05271344


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