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The Effect of Lactoferrin in High Calorie Formula on IL-6 and IL10 in Children With Failure to Thrive and Infection (Interleukin)

Primary Purpose

Failure to Thrive, Infections

Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
High Calorie Formula
Sponsored by
Universitas Airlangga
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Failure to Thrive focused on measuring IL-6, High Calorie Formula, Lacoferrin, IL-10

Eligibility Criteria

1 Year - 5 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

• Children aged 1 - 5 years were diagnosed with failure to thrive with infections (TB or UTI)

Exclusion Criteria:

  • Fluid retention
  • Organomegaly
  • Tumor mass
  • Congenital abnormalities
  • Cerebral Palsy
  • Hormonal disorders and syndrome

Drop out Criteria:

• Lost contact

Sites / Locations

  • Husada Utama Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Interventional study with a pre-, post-test design

Arm Description

After the subject are diagnosed with infection (tuberculosis/TB or urinary tract infection/ UTI), they will receive 400 kcal/day (96 g/day divided 4 times consumption) of high calorie formula prescribed by the researcher (A pediatrician) for 90 days consumption ( 8640 g). the subject will be monitored every 30 days for acceptance, tolerance, weight increment, length increment evaluation. The blood are withdrawn at day 0 (before invention) and day 90 (after intervention) to measure the IL-6 and IL-10 levels

Outcomes

Primary Outcome Measures

Acceptance and tolerance of high calorie formula by the subject
Change on IL-6 levels (in ng/mL), the data will be presented as mean +/- SD. The level of IL-6 will be investigated using human IL-6 ELISA kit (BT Lab)
Acceptance and tolerance of high calorie formula by the subject
Change on IL-10 (in ng/mL), the data will be presented as mean +/- SD. The level of IL-10 will be investigated using human IL-10 ELISA kit (BT Lab)

Secondary Outcome Measures

Acceptance and tolerance of high calorie formula by the subject
Change on body weight (in kg) the data will be presented as mean +/- SD.The body weight will be measure using digital baby scale (Seca 354) and digital scale Seca Robusta 813.
Acceptance and tolerance of high calorie formula by the subject
Change on body length/body height (in cm). The body length/height will be measure using infantometer (Seca 416) and stadiometer (for children aged < 2 years, Seca 213)

Full Information

First Posted
March 5, 2022
Last Updated
October 2, 2022
Sponsor
Universitas Airlangga
Collaborators
Danone Institute International
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1. Study Identification

Unique Protocol Identification Number
NCT05289674
Brief Title
The Effect of Lactoferrin in High Calorie Formula on IL-6 and IL10 in Children With Failure to Thrive and Infection
Acronym
Interleukin
Official Title
The Effect of Lactoferrin in High Calorie Formula on IL-6 and IL10 in Children With Failure to Thrive and Infection
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
October 4, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitas Airlangga
Collaborators
Danone Institute International

4. Oversight

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

5. Study Description

Brief Summary
Lactoferrin is an iron-binding glycoprotein of the transferrin family which is expressed and refers to it as a "red protein from milk". It is known that lactoferrin can modulate the overall immune response in inflammatory disorders including modulation of cytokine/ chemokine production and immune regulation that resenting by interleukin (IL)-10. Children with failure to thrive have increase the risk of infectious disease. The mechanism behind this may be due to impaired of immune function, in which pro-inflammation response is increased (IL-1β, IL-6), while IL-10 acted as anti-inflammation response tends to reduces. High calorie formula (Oral Nutrition Supplement/ONS) are products used for oral nutrition support with the aim of increasing nutritional intake. they are a nutrition treatment option for when nutrition support has been identified beside dietary counselling. ONS are typically used in addition to a normal diet, when diet alone is insufficient to meet daily nutritional requirement due to infection or others. ONS should be treated like medication, ensure they are labelled with the patient's name and provided at the prescribed time. It is well established that nutritional deficiency or inadequate can impair immune function. Growing evidence suggest that for certain nutrients increased intake above currently recommended levels may help optimize immune function including improving the defense function and thus resistance to infection while maintaining tolerance. This study aims to analize the levels of IL-6 and IL- 10 in children with failure to thrive with infection before and after receiving the intervention of lactoferrin in high-calorie formula milk. This study is an observational study with a pre-, post-test design, with designed total subject is 80. The subject is healthy children with weight faltering aged 1-5 years diagnosed with infection (tuberculosis/TB or urinary tract infection/UTI)
Detailed Description
Interventional study with a pre-, post-test design. After the subject were diagnosed with infection (tuberculosis/TB or urinary tract infection/ UTI), they will receive 400 kcal/day (96 g/day divided 4 times consumption) of high calorie formula prescribed by the researcher (A pediatrician) for 90 days consumption (8640 g). the subject will monitored every 30 days for acceptance, tolerance, weight increment, length increment evaluation. The blood will be withdrawn at day 0 (before invention) and day 90 (after intervention) to measure the IL-6 and IL-10 levels. The high calorie formula is given as much as 400 kcal/day for 90 days after the subject were diagnosed with tuberculosis (TB) or urinary tract infection (UTI), determine as day 1. the diagnosis will be determined by pediatrician. Before the intervention (day 0) and after the intervention (day 61), the subjects were taken the blood by laboratory employee of the private hospital in Surabaya, Indonesia

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Failure to Thrive, Infections
Keywords
IL-6, High Calorie Formula, Lacoferrin, IL-10

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This study is an observational study with a pre-, post-test design
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interventional study with a pre-, post-test design
Arm Type
Experimental
Arm Description
After the subject are diagnosed with infection (tuberculosis/TB or urinary tract infection/ UTI), they will receive 400 kcal/day (96 g/day divided 4 times consumption) of high calorie formula prescribed by the researcher (A pediatrician) for 90 days consumption ( 8640 g). the subject will be monitored every 30 days for acceptance, tolerance, weight increment, length increment evaluation. The blood are withdrawn at day 0 (before invention) and day 90 (after intervention) to measure the IL-6 and IL-10 levels
Intervention Type
Dietary Supplement
Intervention Name(s)
High Calorie Formula
Intervention Description
The high calorie formula is given as much as 300 kcal/day for 90 days after the subject were diagnosed with tuberculosis (TB) or urinary tract infection (UTI), determine as day 1. the diagnosis were determined by pediatrician. Before the intervention (day 0) and after the intervention (day 61), the subjects were taken the blood by laboratory employee of the private hospital in Surabaya, Indonesia
Primary Outcome Measure Information:
Title
Acceptance and tolerance of high calorie formula by the subject
Description
Change on IL-6 levels (in ng/mL), the data will be presented as mean +/- SD. The level of IL-6 will be investigated using human IL-6 ELISA kit (BT Lab)
Time Frame
90 days
Title
Acceptance and tolerance of high calorie formula by the subject
Description
Change on IL-10 (in ng/mL), the data will be presented as mean +/- SD. The level of IL-10 will be investigated using human IL-10 ELISA kit (BT Lab)
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Acceptance and tolerance of high calorie formula by the subject
Description
Change on body weight (in kg) the data will be presented as mean +/- SD.The body weight will be measure using digital baby scale (Seca 354) and digital scale Seca Robusta 813.
Time Frame
90 days
Title
Acceptance and tolerance of high calorie formula by the subject
Description
Change on body length/body height (in cm). The body length/height will be measure using infantometer (Seca 416) and stadiometer (for children aged < 2 years, Seca 213)
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: • Children aged 1 - 5 years were diagnosed with failure to thrive with infections (TB or UTI) Exclusion Criteria: Fluid retention Organomegaly Tumor mass Congenital abnormalities Cerebral Palsy Hormonal disorders and syndrome Drop out Criteria: • Lost contact
Facility Information:
Facility Name
Husada Utama Hospital
City
Surabaya
State/Province
East Java
ZIP/Postal Code
60131
Country
Indonesia

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Lactoferrin in High Calorie Formula on IL-6 and IL10 in Children With Failure to Thrive and Infection

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