Failure to ThriveInterleukinNCT05289674
The Effect of Lactoferrin in High Calorie Formula on IL-6 and IL10 in Children With Failure to Thrive and Infection
A study testing High Calorie Formula in people with Failure to Thrive and Infections, run by Universitas Airlangga at 1 site in Indonesia.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 year to 5 years
- Conditions the study is for
- Failure to Thrive, Infections
- What is being tested?
- High Calorie Formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteIndonesia
- Study dates
- 4 Oct 2021to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 1 - 5 years were diagnosed with failure to thrive with infections (TB or UTI)
Who cannot join
- Fluid retention
- Organomegaly
- Tumor mass
- Congenital abnormalities
- Cerebral Palsy
- Hormonal disorders and syndrome
- Drop out Criteria:
- Lost contact
Trial locations and contacts
1 site in 1 country.
About this study
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)
Read the 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
- Being tested
- High Calorie Formula
- Keywords
- IL-6, High Calorie Formula, Lacoferrin, IL-10
- Medical subject headings
- Failure to Thrive, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Calorie FormulaDietary 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: High Calorie Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 90 days
Secondary outcomes (2)
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.
Measured: 90 days
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)
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2022
- Study start4 Oct 2021
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Failure to ThriveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study is an observational study with a pre-, post-test design
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Airlangga
- Sponsor type
- University, hospital or other
- Collaborators
- Danone Institute International
- Responsible party
- Principal investigator, Andy Darma, MD, Universitas Airlangga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05289674
- Sponsor's protocol ID
- J number
- Acronym
- Interleukin
- Status last verified
- Oct 2022
- First submitted
- 5 Mar 2022
- Last updated
- 4 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38434639
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lactoferrin in High Calorie Formula on IL-6 and IL10 in Children With Failure to Thrive and Infection
- ClinicalTrials.gov ID
- NCT05289674
- Acronym / sponsor ID
- Interleukin / J number
- Conditions
- Failure to Thrive, Infections
- Keywords
- IL-6, High Calorie Formula, Lacoferrin, IL-10
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Universitas AirlanggaUniversity, hospital or other
- Collaborators
- Danone Institute International
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 21 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study is an observational study with a pre-, post-test design
| Arm | Type | Receives |
|---|---|---|
| Interventional study with a pre-, post-test design | Experimental | Dietary Supplement: High Calorie FormulaAfter 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 |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children aged 1 - 5 years were diagnosed with failure to thrive with infections (TB or UTI)
Key exclusion criteria (8 listed)
- Fluid retention
- Organomegaly
- Tumor mass
- Congenital abnormalities
- Cerebral Palsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Calorie FormulaThe 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 | Dietary supplement | Interventional study with a pre-, post-test design |
Primary outcome
Acceptance and tolerance of high calorie formula by the subject
Time frame: 90 days
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
Time frame: 90 days
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)
2 secondary outcomes
Acceptance and tolerance of high calorie formula by the subject
Time frame: 90 days
Acceptance and tolerance of high calorie formula by the subject
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2022.
- Derived from this study: PubMed 38434639Widjaja 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Calorie Formula in people with Failure to Thrive and Infections, run by Universitas Airlangga at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptance and tolerance of high calorie formula by the subject (time frame: 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05289674, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2022.