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

NCT05289674 | Completed

• 1 other identifier: J number
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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)

Conditions

Failure to Thrive; Infections

Keywords

IL-6; High Calorie Formula; Lacoferrin; IL-10

Outcome Measures

Primary Outcomes (2)

• 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)

  90 days

• 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)

  90 days

Secondary Outcomes (2)

• Acceptance and tolerance of high calorie formula by the subject

  90 days

• Acceptance and tolerance of high calorie formula by the subject

  90 days

Study Arms (1)

Interventional study with a pre-, post-test design

EXPERIMENTAL

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

Dietary Supplement: High Calorie Formula

Interventions

High Calorie Formula DIETARY_SUPPLEMENT

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

Interventional study with a pre-, post-test design

Eligibility Criteria

• Age: 1 Year - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Fluid retention
• Organomegaly
• Tumor mass
• Congenital abnormalities
• Cerebral Palsy
• Hormonal disorders and syndrome
• Drop out Criteria:
• Lost contact

Sponsors & Collaborators

• Universitas Airlangga: lead
• Danone Institute International: collaborator

Study Sites (1)

Husada Utama Hospital

Surabaya, East Java, 60131, Indonesia

Location

Related Publications (1)

• Widjaja NA, Hamidah A, Purnomo MT, Ardianah E. Effect of lactoferrin in oral nutrition supplement (ONS) towards IL-6 and IL-10 in failure to thrive children with infection. F1000Res. 2023 Dec 19;12:897. doi: 10.12688/f1000research.130176.3. eCollection 2023.

  PMID: 38434639 DERIVED

MeSH Terms

Conditions

Failure to Thrive; Infections

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator on Gastroenterology

Model Details: This study is an observational study with a pre-, post-test design

Study Record Dates

• First Submitted: March 5, 2022
• First Posted: March 21, 2022
• Study Start: October 4, 2021
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: October 4, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)