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Urinary Tract Infections in ChildrenPhase 3NCT06109688

Effect of Lactoferrin Supplementation on Urinary Tract Infections in Infants.

A Phase 3 study testing Bovine Lactoferrin in people with Urinary Tract Infections in Children, run by Medical University of Lublin.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of the study was to evaluate the efficacy of orally administered bovine lactoferrin (bLF) on Urinary Tract Infections in neonates and infants. Fifty-five patients with urinary tract infection were randomized to receive either bLF (n = 27) or an identical placebo (n = 28) for 4 weeks. Read more about this study

Who is it for?
Ages 7 days to 12 months
Conditions the study is for
Urinary Tract Infections in Children
What is being tested?
Bovine Lactoferrin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
55 participants
Where
No sites listed yet
Study dates
1 Jul 2015to 15 Feb 2018
Phase
Phase 3
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 7 days to 12 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Neonates and infants with symptoms of Urinary Tract Infection.
  • Active infection at enrollment, confirmed and documented in medical record.
  • Children with Urinary Tract Infection treated according to current recommendations.

Who cannot join

  • Unconfirmed Urinary Tract Infection.
  • Critical illness and/or hemodynamic instability.
  • Allergy or sensitivity to lactoferrin or bovine derived proteins or bovine milk.
  • Children whose parents/guardians decline to participate.

About this study

Official title: Effect of Lactoferrin Supplementation on Urinary Tract Infections in Infants: a Randomised, Double-blind, Placebo-controlled Trial.

The aim of the study was to evaluate the efficacy of orally administered bovine lactoferrin (bLF) on Urinary Tract Infections in neonates and infants. Fifty-five patients with urinary tract infection were randomized to receive either bLF (n = 27) or an identical placebo (n = 28) for 4 weeks. The patients were assessed clinically and laboratory.

Read the detailed description

This study was a prospective randomized controlled trial at a single university medical center. Participants were neonates or infants with Urinary Tract Infection (UTI) admitted to the Neonatal and Infant Pathology Department of Children's University Hospital in the period from July 2015 to December 2017. The intervention was bovine lactoferrin at a dosage of 100 mg/day for a period of 4 weeks compared with placebo in a control group.

During hospital treatment, laboratory tests were performed to evaluate the activity of inflammatory markers (C-reactive protein, procalcitonin, Interleukin-6 and Interleukin-8 levels and white blood cell count).

Fifty-five patients heve been included in the study.

Being tested
Bovine Lactoferrin, placebo
Keywords
urinary tract infections, infants, lactoferrin
Medical subject headings
Urinary Tract Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bovine LactoferrinDietary supplement

    Also called Lactoferrin 100 mg

    Orally intake 1 sachet per day for 4 weeks. Lactoferrin will be dissolved in human milk or infant formula or in a 5% glucose solution.

  • placeboDietary supplement

    Also called Maltodextrin

    Orally intake 1 sachet per day for 4 weeks. Maltodextrin will be dissolved in human milk or infant formula or in a 5% glucose solution.

Study groups in NCT06109688
Study groupRoleWhat they receive
Bovine lactoferrinExperimentalSachets with bovine lactoferrin at a dosage of 100 mg/day for a period of 4 weeks.
Receives: Dietary Supplement: Bovine Lactoferrin
PlaceboPlacebo comparatorMatched sachets with maltodextrin for a period of 4 weeks.
Receives: Dietary Supplement: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Monitoring of parameters of inflammation.

    C-reactive protein and procalcitonin levels in both groups. Comparing possible change.

    Measured: at baseline, after 5 days of treatment

  2. Influence of lactoferrin on Interleukin-6 and Interleukin-8.

    Levels of Interleukin in both groups. Comparing possible change.

    Measured: at baseline, after 5 days of treatment

  3. Effect of lactoferrin on white blood cells.

    To assess the change in the number of leukocytes, neutrophils, lymphocytes, monocytes, eosinophils and basophils.

    Measured: at baseline, after 5 days of treatment

  4. Effect of lactoferrin on urinary inflammatory markers.

    The presence of bacteria in urine and semi-quantitative measurement of white blood cells count in urine.

    Measured: at baseline, after 5 days of treatment

Secondary outcomes (3)

  1. To evaluate the efficacy of lactoferrin in the reduction of probable recurrence of Urinary Tract Infection.

    The number of recurrent Urinary Tract Infections occur due to bacterial reinfection or bacterial persistence.

    Measured: 1 month

  2. The number of days of hospitalization.

    Length of stay. Comparing possible differences in groups.

    Measured: 1 month

  3. Evaluation of the safety of the administration of lactoferrin by monitoring possible adverse effects.

    Incidence, frequency and severity of treatment emergent adverse events.

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2023
  2. Study start1 Jul 2015
  3. Primary completion31 Dec 2017
  4. Study completion15 Feb 2018

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
patients with Urinary Tract Infections were recruited subjects were randomized into two groups: * the experimental group received bLF * the control group received placebo without bLF
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06109688
Sponsor's protocol ID
0254/297/2014
Status last verified
Oct 2023
First submitted
27 Apr 2020
Last updated
31 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Manzoni P, Dall'Agnola A, Tome D, Kaufman DA, Tavella E, Pieretto M, Messina A, De Luca D, Bellaiche M, Mosca A, Piloquet H, Simeoni U, Picaud JC, Del Vecchio A. Role of Lactoferrin in Neonates and Infants: An Update. Am J Perinatol. 2018 May;35(6):561-565. doi: 10.1055/s-0038-1639359. Epub 2018 Apr 25.

    PubMed 29694997

  • Artym J, Zimecki M. [The role of lactoferrin in the proper development of newborns]. Postepy Hig Med Dosw (Online). 2005;59:421-32. Polish.

    PubMed 16106243

  • Balighian E, Burke M. Urinary Tract Infections in Children. Pediatr Rev. 2018 Jan;39(1):3-12. doi: 10.1542/pir.2017-0007. No abstract available.

    PubMed 29292282

  • Garout WA, Kurdi HS, Shilli AH, Kari JA. Urinary tract infection in children younger than 5 years. Etiology and associated urological anomalies. Saudi Med J. 2015 Apr;36(4):497-501. doi: 10.15537/smj.2015.4.10770.

    PubMed 25828291

  • Renata Y, Jassar H, Katz R, Hochberg A, Nir RR, Klein-Kremer A. Urinary concentration of cytokines in children with acute pyelonephritis. Eur J Pediatr. 2013 Jun;172(6):769-74. doi: 10.1007/s00431-012-1914-2. Epub 2013 Feb 7.

    PubMed 23389820

  • Krzemien G, Szmigielska A, Turczyn A, Panczyk-Tomaszewska M. Urine interleukin-6, interleukin-8 and transforming growth factor beta1 in infants with urinary tract infection and asymptomatic bacteriuria. Cent Eur J Immunol. 2016;41(3):260-267. doi: 10.5114/ceji.2016.63125. Epub 2016 Oct 25.

    PubMed 27833443

  • Miguel-Bayarri V, Casanoves-Laparra EB, Pallas-Beneyto L, Sancho-Chinesta S, Martin-Osorio LF, Tormo-Calandin C, Bautista-Rentero D. Prognostic value of the biomarkers procalcitonin, interleukin-6 and C-reactive protein in severe sepsis. Med Intensiva. 2012 Nov;36(8):556-62. doi: 10.1016/j.medin.2012.01.014. Epub 2012 Apr 10. English, Spanish.

    PubMed 22495097

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bovine Lactoferrin in people with Urinary Tract Infections in Children, run by Medical University of Lublin.

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 3 inclusion and 4 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 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Monitoring of parameters of inflammation. (time frame: at baseline, after 5 days of treatment). The study lists 4 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 NCT06109688, which also lists 7 linked publications.

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 31 Oct 2023.

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