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Effects of synbiotic supplementation on energy and macronutrients homeostasis and muscle wasting of critical care patients: A randomized controlled trial

Protocol summary

Study aim
Evaluating the effects of synbiotic supplementation on energy and macronutrient homeostasis and muscle wasting in critical care patients
Design
This is a prospective, single center, double-blind, parallel randomized controlled trial
Settings and conduct
The setting of the trial will be Edalatian ICU,Emam Reza Hospital,Mashhad,Iran.ٍّExcept pharmacy company and ward secretary,all patients,researchers,and medical staff will be blind.Energy requirement will be estimated according to ESPEN guideline 2018.In the hight and low nutritional risk patients enteral nutrition will be started by 50% and 30% of estimated calorie respectively.In everyday visits,we will evaluate enteral nutrition tolerance. If tolerated,EN will be increased by 10% each day to achieve calorie target. Before and after the intervention,blood and 24h urine samples will be collected.
Participants/Inclusion and exclusion criteria
Inclusion: Adults aged 18-65 years, ICU admission, stable hemodynamic within 24-48 hour after admission, requiring enteral nutrition via nasogastric tube feeding, and providing the written consent. exclusion:Pregnancy and lactation, any contraindication of EN, any contraindication to placement of nasogastric feeding tube, receiving immunosuppressive treatment, radiotherapy or chemotherapy, hematologic diseases,immune deficiency, transplant recipient, known allergy,cancer or autoimmune diseases, insulin-dependent diabetes, organ failure, sepsis, artificial heart valve or congenital heart disease.
Intervention groups
Lactocare (ZistTakhmir, Iran) capsules 500 mg every 12h for 14 days Placebo capsules (ZistTakhmir, Iran) every 12h for 14 days
Main outcome variables
Enteral feeding tolerance;Energy homeostasis;Protein catabolis;Muscle protein degradation;Muscle protein turnover;Lipolysi;Glucose homeostasis;Inflammatory status;Dysbiosis tatus and luminal integrity;Clinical prognosis;Nutritional status

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190227042857N1
Registration date: 2019-03-17, 1397/12/26
Registration timing: prospective

Last update: 2019-03-17, 1397/12/26
Update count: 0
Registration date
2019-03-17, 1397/12/26
Registrant information
Name
Najmeh Seifi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 8642
Email address
seifin941@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-06, 1398/01/17
Expected recruitment end date
2019-10-09, 1398/07/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of synbiotic supplementation on energy and macronutrients homeostasis and muscle wasting of critical care patients: A randomized controlled trial
Public title
Symbiotic supplementation effect oncritical care patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adults aged 18-65 years ICU admission stable hemodynamic within 24-48 hour after admission requiring enteral nutrition(EN) via nasogastric tube (NGT) feeding not taking any kind of microbial cell preparations (pre, pro, synbiotic) providing the written consent
Exclusion criteria:
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Data analyser
Sample size
Target sample size: 21
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization will be performed through a stratified sequential randomization plan generated online. Randomization will be stratified by disease severity (APACHEII , 0-35 and 35-70).
Blinding (investigator's opinion)
Double blinded
Blinding description
All patients, researchers, and medical staff will be blind about receiving either synbiotic or placebo capsules.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethical committee of Mashhad University of Medical Sciences
Street address
Qureishi Building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
91735-951
Approval date
2019-02-27, 1397/12/08
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1397.715

Health conditions studied

1

Description of health condition studied
energy and macronutrient homeostasis disturbance- muscle wasting
ICD-10 code
E46
ICD-10 code description
Unspecified protein-calorie malnutrition

Primary outcomes

1

Description
Energy homeostasis
Timepoint
daily
Method of measurement
calorie intake- estimated calorie requirement

2

Description
protein catabolism
Timepoint
7, 14 days after intervention
Method of measurement
nitrogen balance

3

Description
Muscle protein turnover
Timepoint
14 days after intervention
Method of measurement
3MH/ Creatinine ratio in 24h urine

4

Description
Lipolysis
Timepoint
14 days after intervention
Method of measurement
free glycerol in serum

5

Description
Dysbiosis status and luminal integrity
Timepoint
14 days after intervention
Method of measurement
blood Endotoxin levels

Secondary outcomes

1

Description
Infectious complications incidence
Timepoint
daily
Method of measurement
incidence

2

Description
Ventilator- dependent days
Timepoint
14 days after intervention
Method of measurement
number of days

3

Description
Length of ICU stay
Timepoint
14 days after intervention
Method of measurement
number of days

4

Description
Length of hospital stay
Timepoint
14 days after intervention
Method of measurement
number of days

5

Description
28- Day mortality
Timepoint
28 days after intervention
Method of measurement
mortality incidence in 28 days

Intervention groups

1

Description
Intervention group: Lactocare (ZistTakhmir,Tehran, Iran) capsules 500 mg every 12h for 14 days
Category
Treatment - Drugs

2

Description
Control group: placebo every 12h for 14 days
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Edalatian ICU of Imam Reza Hospital
Full name of responsible person
Alireza Sedaghat
Street address
Imam Reza Hospital, Shariati Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
sedaghatar@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Research Chancellor, Qureishi Building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
91735-951
Phone
+98 51 3841 2081
Email
vcresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Najmeh Seifi
Position
PhD candidate
Latest degree
Medical doctor
Other areas of specialty/work
Nutrition
Street address
Nutrition Dept.,Medical School, University Paradise,Vakilabad Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3882 7033
Email
seifin941@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Najmeh Seifi
Position
PhD candidate
Latest degree
Medical doctor
Other areas of specialty/work
Nutrition
Street address
Nutrition Dept., Medical School,University Paradise, Vakilabad Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3882 7033
Email
seifin941@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Najmeh Seifi
Position
PhD Candidate
Latest degree
Medical doctor
Other areas of specialty/work
Nutrition
Street address
Nutrition Dept, .Medical School, University Paradise,Vakilabad Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3882 7033
Email
seifin941@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Study protocol will be published in a scientific journal. Clinical study reports will be published in a scientific journal at the end.
When the data will become available and for how long
Undecided
To whom data/document is available
Undecided
Under which criteria data/document could be used
Undecided
From where data/document is obtainable
Undecided
What processes are involved for a request to access data/document
Undecided
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