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

NCT ID: NCT05289674

Last Updated: 2022-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-04
• Study Completion Date: 2022-06-30

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

Conditions

Failure to Thrive; Infections

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Interventional study with a pre-, post-test design

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

Group Type: EXPERIMENTAL

High Calorie Formula

Intervention Type: 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

Interventions

High Calorie Formula

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

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Danone Institute International

OTHER

Sponsor Role: collaborator

Universitas Airlangga

OTHER

Sponsor Role: lead

Responsible Party

Andy Darma, MD

Principal Investigator on Gastroenterology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Husada Utama Hospital

Surabaya, East Java, Indonesia

Countries

Indonesia

References

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.

Reference Type: DERIVED

PMID: 38434639 (View on PubMed)

Other Identifiers

J number

Identifier Type: -

Identifier Source: org_study_id