Fungal InfectionPhase 1NCT05283278
Effect of Administration of Combined Enteral Lactoferrin and Probiotic On Invasive Fungal Infections In Preterm Neonates
A Phase 1 study testing Lactoferrin Bovine and Lactoferrin Bovine and probiotics in people with Fungal Infection, run by Ain Shams University at 1 site in Egypt.
Trial summary
The risk for invasive fungal infections is high in very low birth weight (VLBW) infants (< 1500 g) and highest for infants born at the youngest gestational ages who survive past the immediate postnatal period. Read more about this study
- Who is it for?
- Ages 1 day to 30 days
- Conditions the study is for
- Fungal Infection
- What is being tested?
- Lactoferrin Bovine and Lactoferrin Bovine and probiotics
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Feb 2020to 27 Apr 2021
- Phase
- Phase 1
- 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 day to 30 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 80 preterm
- ≤ 36 weeks gestational age
- >/ = 72 hours of life
Who cannot join
- Nothing per os
- Congenital anomalies.
- Suspected inborn error of metabolism.
- Prophylaxis antifungal drugs
Trial locations and contacts
1 site in 1 country.
About this study
The risk for invasive fungal infections is high in very low birth weight (VLBW) infants (< 1500 g) and highest for infants born at the youngest gestational ages who survive past the immediate postnatal period.
Invasive fungal infections (IFIs) represent an increasing cause of severe morbidity and mortality in most neonatal intensive care units.
Read more
Lactoferrin (LF) is secreted by epithelial cells into exocrine fluids: seminal fluid, tears, saliva, uterine secretions, and milk. LF is involved in innate immunity mechanisms with several documented anti-infective properties, including antifungal activity.
Probiotics are microorganisms that are believed to provide health benefits when consumed.
It is possible to adopt measures to modify the flora in our bodies and to replace the harmful microbes by useful microbes.
There are certain commercially available strains of probiotic bacteria from the Bifido bacterium and Lactobacillus genera when taken by mouth in daily doses possess treatment efficacy
Read the detailed description
Bovine LF alone or in combination of probiotics (Lactobacillus Delbrueckii and Lactobacillus Fermentum) can be used in prevention of invasive fungal infection in preterm neonates admitted to the NICU. So, this randomized interventional study aimed at evaluation of the efficacy and safety of enterally administered bovine LF alone or in combination of probiotics (Lactobacillus Delbrueckii and Lactobacillus Fermentum) in comparison to placebo in preterm neonates, through studying blood culture for fungal infection at enrollment, day 7, 14, 21 and 28 using Sabouraud agar for detecting Candida species and Hichrome agar to detect other fungal types ( primary outcome), and to compare length of hospital stay (LOS), use and duration of drug intake as antibiotics and inotropes, use and duration of mechanical ventilation, rate of increase of enteral feeding, time to reach full enteral intake, signs of feeding intolerance, complete blood count (CBC), C reactive protein (CRP), packed red blood cell transfusion (PRBCs) and mortality between the 3 groups as (secondary outcome).
- Conditions
- Fungal Infection
- Being tested
- Lactoferrin Bovine, Lactoferrin Bovine and probiotics, Placebo
- Keywords
- Lactoferrin, Probiotic, Preterm
- Medical subject headings
- Mycoses, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactoferrin BovineDrug
Also called Pravotin®
Lactoferrin granules (Pravotin®) in a dose of 100 mg /kg/day starting from birth to the 30th day of life for neonates in group A
Lactoferrin Bovine and probioticsCombination product
Also called Pravotin® plus Lacteol fort
Lactoferrin granules (Pravotin®) in a dose of 100 mg /kg/day in combination with the probiotic Lactobacillus Delbrueckii and Lactobacillus Fermentum (Lacteol fort®) given in a dose of 5 billions starting from birth to the 30th day of life for neonates in group B
PlaceboOther
Placebo will be given starting from birth to the 30th day of life for neonates in group C.
| Study group | Role | What they receive |
|---|---|---|
| Lactoferrin Bovine group | Active comparator | Group A (20 preterm neonates) which will receive lactoferrin (100mg/day) Receives: Drug: Lactoferrin Bovine |
| Lactoferrin Bovine with probiotics group | Active comparator | Group B (20 preterm neonates) which will receive lactoferrin (100mg/day) in combination with the probiotic Receives: Combination Product: Lactoferrin Bovine and probiotics |
| Placebo group | Placebo comparator | Group C (40 preterm neonates) which is a placebo group. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with invasive fungal infection (IFI)
Efficacy of enteral lactoferrin either alone or in combination with the probiotic Lactobacillus Delbrueckii and Lactobacillus Fermentum in the prevention of invasive fungal infections in preterm infants through analyzing the incidence rates of invasive fungal infection (IFI) in all groups using Sabouraud agar for detecting Candida species and Hichrome agar to detect other fungal types.
Measured: 12 months
Secondary outcomes (6)
Number of patients who received packed RBC in each group
The number of patients who received packed RBC in each group from time of enrollment till the 30th day of life
Measured: 30 days
Days on inotropic support in each group
Define how many days required for inotropic support in each group
Measured: 12 months
Days on mechanical ventilation in each group
Define how many days required for mechanical ventilation support in each group
Measured: 12 months
Days of NICU admission in each group
Define how many days patients in each group were admitted in the NICU
Measured: 12 monthes
Number of participants with Necrotizing enterocolitis in each group
Define the rate of NEC occurrence in each group
Measured: 12 months
Mortality in each group
Define the number of mortality in each group
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start10 Feb 2020
- Primary completion27 Mar 2021
- Study completion27 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fungal InfectionStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hebatallah A Shaaban, MD, Ain Shams University
- Investigators
- Hebatallah A Shaaban, MD, Study director, Doctor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05283278
- Sponsor's protocol ID
- Pediatrics Dep-ASU
- Status last verified
- Mar 2022
- First submitted
- 17 Oct 2017
- Last updated
- 16 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Administration of Combined Enteral Lactoferrin and Probiotic On Invasive Fungal Infections In Preterm Neonates
- ClinicalTrials.gov ID
- NCT05283278
- Acronym / sponsor ID
- Pediatrics Dep-ASU
- Conditions
- Fungal Infection
- Keywords
- Lactoferrin, Probiotic, Preterm
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 10 Feb 2020 (actual)
- Primary completion
- 27 Mar 2021 (actual)
- Study completion
- 27 Apr 2021 (actual)
- First posted
- 16 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.
The risk for invasive fungal infections is high in very low birth weight (VLBW) infants (< 1500 g) and highest for infants born at the youngest gestational ages who survive past the immediate postnatal period.
Invasive fungal infections (IFIs) represent an increasing cause of severe morbidity and mortality in most neonatal intensive care units.
Lactoferrin (LF) is secreted by epithelial cells into exocrine fluids: seminal fluid, tears, saliva, uterine secretions, and milk. LF is involved in innate immunity mechanisms with several documented anti-infective properties, including antifungal activity.
Probiotics are microorganisms that are believed to provide health benefits when consumed.
It is possible to adopt measures to modify the flora in our bodies and to replace the harmful microbes by useful microbes.
There are certain commercially available strains of probiotic bacteria from the Bifido bacterium and Lactobacillus genera when taken by mouth in daily doses possess treatment efficacy
Detailed description
Bovine LF alone or in combination of probiotics (Lactobacillus Delbrueckii and Lactobacillus Fermentum) can be used in prevention of invasive fungal infection in preterm neonates admitted to the NICU. So, this randomized interventional study aimed at evaluation of the efficacy and safety of enterally administered bovine LF alone or in combination of probiotics (Lactobacillus Delbrueckii and Lactobacillus Fermentum) in comparison to placebo in preterm neonates, through studying blood culture for fungal infection at enrollment, day 7, 14, 21 and 28 using Sabouraud agar for detecting Candida species and Hichrome agar to detect other fungal types ( primary outcome), and to compare length of hospital stay (LOS), use and duration of drug intake as antibiotics and inotropes, use and duration of mechanical ventilation, rate of increase of enteral feeding, time to reach full enteral intake, signs of feeding intolerance, complete blood count (CBC), C reactive protein (CRP), packed red blood cell transfusion (PRBCs) and mortality between the 3 groups as (secondary outcome).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lactoferrin Bovine group | Active comparator | Drug: Lactoferrin BovineGroup A (20 preterm neonates) which will receive lactoferrin (100mg/day) |
| Lactoferrin Bovine with probiotics group | Active comparator | Combination Product: Lactoferrin Bovine and probioticsGroup B (20 preterm neonates) which will receive lactoferrin (100mg/day) in combination with the probiotic |
| Placebo group | Placebo comparator | Other: PlaceboGroup C (40 preterm neonates) which is a placebo group. |
Who may qualify
- Ages
- 1 day to 30 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 80 preterm
- ≤ 36 weeks gestational age
- >/ = 72 hours of life
Key exclusion criteria (4 listed)
- Nothing per os
- Congenital anomalies.
- Suspected inborn error of metabolism.
- Prophylaxis antifungal drugs
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 |
|---|---|---|
| Lactoferrin BovineAlso: Pravotin®Lactoferrin granules (Pravotin®) in a dose of 100 mg /kg/day starting from birth to the 30th day of life for neonates in group A | Drug | Lactoferrin Bovine group |
| Lactoferrin Bovine and probioticsAlso: Pravotin® plus Lacteol fortLactoferrin granules (Pravotin®) in a dose of 100 mg /kg/day in combination with the probiotic Lactobacillus Delbrueckii and Lactobacillus Fermentum (Lacteol fort®) given in a dose of 5 billions starting from birth to the 30th day of life for neonates in group B | Combination product | Lactoferrin Bovine with probiotics group |
| PlaceboPlacebo will be given starting from birth to the 30th day of life for neonates in group C. | Other | Placebo group |
Primary outcome
Number of participants with invasive fungal infection (IFI)
Time frame: 12 months
Efficacy of enteral lactoferrin either alone or in combination with the probiotic Lactobacillus Delbrueckii and Lactobacillus Fermentum in the prevention of invasive fungal infections in preterm infants through analyzing the incidence rates of invasive fungal infection (IFI) in all groups using Sabouraud agar for detecting Candida species and Hichrome agar to detect other fungal types.
6 secondary outcomes
Number of patients who received packed RBC in each group
Time frame: 30 days
Days on inotropic support in each group
Time frame: 12 months
Days on mechanical ventilation in each group
Time frame: 12 months
Days of NICU admission in each group
Time frame: 12 monthes
Number of participants with Necrotizing enterocolitis in each group
Time frame: 12 months
Mortality in each group
Time frame: 12 months
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 16 Mar 2022.
- Individual participant dataSharing planned: No
Related trials for Fungal Infection
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Active, not recruitingPhase 2
A Study to Learn About How a New Pneumococcal Vaccine Works in Infants
Pneumococcal Disease
Not yet recruiting
Early Pathophysiology of Hidradenitis Suppurativa and Prediction of the Risk of Progression: a Prospective Cohort
Hidradenitis Suppurativa (HS)
Active, not recruitingPhase 2
Dosing of Brentuximab Vedotin for Mycosis Fungoides, Sezary Syndrome Patients
Mycosis Fungoides, Lymphomatoid Papulosis
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.
Hebatallah A Shaaban, MD study director
Doctor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lactoferrin Bovine and Lactoferrin Bovine and probiotics in people with Fungal Infection, run by Ain Shams University at 1 site in Egypt.
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 16 Mar 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 Egypt. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Number of participants with invasive fungal infection (IFI) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Mar 2022.