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Oral Immunonutrition With Synbiotics, Omega 3 and Vitamin D in Patients Undergoing Duodenopancreatectomy for Tumoral Lesion. (SIO3D)

Primary Purpose

Pancreatic Cancer, Complication,Postoperative, Surgery

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Nutritional Products
Sponsored by
Centre Hospitalier Universitaire de Liege
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pancreatic Cancer focused on measuring synbiotics, omega 3, vitamin D, probiotics, prebiotics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHURecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo Group

Treated Group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Calculation of the Comprehensive Complication Index (CCI)
This criterion takes into account all the complications of a given patient by weighting their relative importance. It varies from 0 to 100. A score of 0 means the absence of complications. A score of 100 is the death.

Secondary Outcome Measures

Rate of infectious or non infectious complications and rate of mortality
Wound infection, pulmonary infection, urinary infection, intra-abdominal abscess, sepsis, pancreatic fistula, delayed gastric emptying, wound dehiscence, intestinal obstruction, intra-abdominal bleeding, pulmonary embolism, ...
Research of occult-bacterial translocation in blood samples
q-PCR technique
Metagenomic characterization of the faecal microbiota
Metagenomic sequencing through faecal samples
Blood determination of lipopolysaccharide binding protein
As a measure of intestinal barrier integrity

Full Information

First Posted
January 26, 2022
Last Updated
September 8, 2023
Sponsor
Centre Hospitalier Universitaire de Liege
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1. Study Identification

Unique Protocol Identification Number
NCT05271344
Brief Title
Oral Immunonutrition With Synbiotics, Omega 3 and Vitamin D in Patients Undergoing Duodenopancreatectomy for Tumoral Lesion.
Acronym
SIO3D
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 8, 2022 (Actual)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
March 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre Hospitalier Universitaire de Liege

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer, Complication,Postoperative, Surgery
Keywords
synbiotics, omega 3, vitamin D, probiotics, prebiotics

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
74 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
Placebo products for probiotics, prebiotics, omega 3 and vitamin D
Arm Title
Treated Group
Arm Type
Experimental
Arm 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutritional Products
Intervention Description
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
Primary Outcome Measure Information:
Title
Calculation of the Comprehensive Complication Index (CCI)
Description
This criterion takes into account all the complications of a given patient by weighting their relative importance. It varies from 0 to 100. A score of 0 means the absence of complications. A score of 100 is the death.
Time Frame
From the Day of the operation to the patient's discharge Day of the hospital, up to 90 days after surgery
Secondary Outcome Measure Information:
Title
Rate of infectious or non infectious complications and rate of mortality
Description
Wound infection, pulmonary infection, urinary infection, intra-abdominal abscess, sepsis, pancreatic fistula, delayed gastric emptying, wound dehiscence, intestinal obstruction, intra-abdominal bleeding, pulmonary embolism, ...
Time Frame
up to 90 days after surgery
Title
Research of occult-bacterial translocation in blood samples
Description
q-PCR technique
Time Frame
Day+1 and Day+4 postoperative day
Title
Metagenomic characterization of the faecal microbiota
Description
Metagenomic sequencing through faecal samples
Time Frame
Day-19 (or Day-18, or Day-17, or Day-16) preoperative day and Day-1 preoperative day
Title
Blood determination of lipopolysaccharide binding protein
Description
As a measure of intestinal barrier integrity
Time Frame
Day-19 (or Day-18, or Day-17, or Day-16) preoperative day and the day of the operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alain Pans, MD
Phone
003243667216
Email
a.pans@chuliege.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arnaud De Roover, Pr
Organizational Affiliation
Centre Hospitalier Universitaire de Liege
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Alain Pans, MD
Organizational Affiliation
Centre Hospitalier Universitaire de Liege
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alain Pans, MD
Phone
003243667216
Email
a.pans@chuliege.be

12. IPD Sharing Statement

Citations:
PubMed Identifier
32842475
Citation
Jablonska B, Mrowiec S. The Role of Immunonutrition in Patients Undergoing Pancreaticoduodenectomy. Nutrients. 2020 Aug 23;12(9):2547. doi: 10.3390/nu12092547.
Results Reference
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Oral Immunonutrition With Synbiotics, Omega 3 and Vitamin D in Patients Undergoing Duodenopancreatectomy for Tumoral Lesion.

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