NCT05289674: Interleukin

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

Completed NA Last updated 4 October 2022

What this trial tests

NA trial testing High Calorie Formula in Failure to Thrive in 75 participants. Completed in 30 June 2022.

Timeline

4 October 2021

Primary endpoint
30 June 2022

30 June 2022

Quick facts

Lead sponsor	Universitas Airlangga
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	75
Start date	4 October 2021
Primary completion	30 June 2022
Estimated completion	30 June 2022
Sites	1 location across Indonesia

Drugs / interventions tested

• High Calorie Formula

Conditions studied

• Failure to Thrive — all drugs for Failure to Thrive →
• Infections — all drugs for Infections →

Sponsor

Universitas Airlangga — full company profile →

Who can join

Adults 1 to 5, any sex, with Failure to Thrive or Infections. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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)

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effect of lactoferrin in oral nutrition supplement (ONS) towards IL-6 and IL-10 in failure to thrive children with infection.
   Widjaja NA, Hamidah A, Purnomo MT, Ardianah E. · · 2023 · cited 4× · PMID 38434639 · DOI 10.12688/f1000research.130176.3
2. Effect of lactoferrin in oral nutrition supplement (ONS) towards IL-6 and IL-10 in failure to thrive children with infection
   Widjaja NA, Hamidah A, Purnomo MT, Ardianah E. · · 2023 · DOI 10.12688/f1000research.130176.3