Oral Immunonutrition With Synbiotics, Omega 3 and Vitamin D in Patients Undergoing Duodenopancreatectomy for Tumoral Lesion.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-08

Study Completion Date

2026-03-31

Brief Summary

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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.

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Detailed Description

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To the best knowledge of the Investigators, a comprehensive multimodal approach to reduce postoperative morbidity in duodenopancreatectomies has not yet been evaluated. In the study, the Investigators combine the main nutritional interventions currently available and already having an individual scientific basis, sequentially and simultaneously, for a potential synergistic effect.

In cases of duodenopancreatectomy for tumoral lesion, a group of patients taking only conventional immunonutrition regimen (CIR), for 7 preoperative days, will be compared with a second group where immunonutrition will be maximised by the addition of omega 3 for 1 week prior to the administration of CIR, synbiotics for 14 days pre- and post-operatively, and preoperative vitamin D supplementation for 6 days, in terms of postoperative overall morbidity.

Conditions

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Pancreatic Cancer Complication,Postoperative Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Placebo Group

Placebo products for probiotics, prebiotics, omega 3 and vitamin D

Group Type PLACEBO_COMPARATOR

Nutritional Products

Intervention Type DIETARY_SUPPLEMENT

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

Treated Group

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.

Group Type EXPERIMENTAL

Nutritional Products

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Nutritional 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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No