The Effect of Lactoferrin in High Calorie Formula on IL-6 and IL10 in Children With Failure to Thrive and Infection
Condition: Failure to Thrive; Infections
MeSH terms: Infections; Communicable Diseases; Failure to Thrive
Study type: Interventional

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
    

Intervention name(s): High Calorie Formula
Intervention type(s): Dietary Supplement
Intervention description(s): 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 model: Single Group Assignment
Intervention model description: This study is an observational study with a pre-, post-test design
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: IL-6; High Calorie Formula; Lacoferrin; IL-10