Necrotizing EnterocolitisPhase 3NCT06422000
Effect of Pentoxifylline Versus Probiotic on Preterm Neonates With Necrotizing Enterocolitis
A Phase 3 study testing Pentoxifylline and Probiotic Formula in people with Necrotizing Enterocolitis, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the effectiveness of pentoxifylline versus probiotics supplementation as adjuvant therapy for preterm neonates with necrotizing enterocolitis. Read more about this study
- Who is it for?
- Ages Up to 37 weeks
- Conditions the study is for
- Necrotizing Enterocolitis
- What is being tested?
- Pentoxifylline and Probiotic Formula
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jun 2022to 30 Dec 2023
- 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 Up to 37 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male and female preterm neonates less than 37 weeks gestational age
- Suffering from necrotizing enterocolitis (NEC), according to Modified Bell's system which was first proposed by Bell et al., 1978 as stage I (suspected), II (proven) .
- Diagnosis of NEC depends on; history, physical examination, laboratory and radiographic findings .
- Signs and symptoms of NEC (at least three or more ), including; unstable temperature, apnea, increased residual milk in stomach, mid abdominal distension, vomiting coffee-like substances, bloody stool
- Laboratory findings including; thrombocytopenia, hypernatremia, metabolic acidosis, neutropenia and leukocytosis.
- Anterior posterior abdominal radiograph is used for diagnosis in which pneomatosis intestinalis in stage II NEC
Who cannot join
- Term and post term neonates
- Neonates with congenital infections
- Neonates with major congenital anomalies
- Neonates with stage III NEC
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pentoxifylline Versus Probiotic as Adjuvant Therapy for Preterm Neonates With Necrotizing Enterocolitis
The aim of this study is to evaluate the effectiveness of pentoxifylline versus probiotics supplementation as adjuvant therapy for preterm neonates with necrotizing enterocolitis.
Read the detailed description
This randomized clinical trial includes 75 preterm infants who met the inclusion criteria for stage I and stage II NEC. Patients are allocated randomly into three groups (each included 25 neonates); group I (traditional therapy group) received antibiotics according to culture and sensitivity results, group II (pentoxifylline group) received antibiotics and IV pentoxifylline at a dose of 30 mg/ Kg given over 6 hours daily until discharge from the unit, and group III (probiotics group) received antibiotics and probiotics sachets supplementation in a dose of 100 mg mixed with 10 ml sterile water and given by Ryle tube once daily until discharge. The serum level of high-mobility group box protein 1 (HMGB-1), intestinal fatty acid binding proteins (I-FABP), and total antioxidant capacity (TAC) were measured on admission and at discharge.
- Conditions
- Necrotizing Enterocolitis
- Being tested
- Pentoxifylline, Probiotic Formula
- Medical subject headings
- Enterocolitis, Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PentoxifyllineDrug
Also called group 2 (Pentoxifylline group)
Pentoxifylline 30 mg/kg given over 6 hours daily
Probiotic FormulaDrug
Also called group 3 (Probiotic group)
probiotics sachets supplementation, in the form of lyophilized lactic acid bacteria each Aluminium stick pack contains 100 mg ( Meyer et al., 2020) Probio Tec BB12-Blend 30- IF* (SANDOZ®.) mixed with 10 ml sterile water and given by Ryle tube once daily until discharge from the unit after clinical and laboratory improvement .
| Study group | Role | What they receive |
|---|---|---|
| control group (group I) | No intervention | will include 25 preterm neonates with NEC who will receive traditional therapy of NEC including antibiotics and normal incubator care measures |
| pentoxifylline group (group II) | Active comparator | will include 25 preterm neonates with NEC who will receive traditional therapy of NEC in association with IV pentoxifylline at a dose of 30 mg/kg given over 6 hours daily (Schüller et al., 2020) until discharge from the unit after clinical and laboratory improvement . Receives: Drug: Pentoxifylline |
| probiotic group (group III) | Active comparator | will include 25 preterm neonates with NEC who will receive traditional therapy of NEC in association with probiotics sachets supplementation, in the form of lyophilized lactic acid bacteria each Aluminium stick pack contains 100 mg ( Meyer et al., 2020) Probio Tec BB12-Blend 30- IF* (SANDOZ®.) mixed with 10 ml sterile water and given by Ryle tube once daily until discharge from the unit after clinical and laboratory improvement . Receives: Drug: Probiotic Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality rate
record mortality rate in each group during treatment
Measured: 2 months
complications and side effects
record any complications or side effects of the treating drugs
Measured: 2 months
Inflammatory parameter
Change in serum C-reactive protein at baseline and after 2 months
Measured: 2 months
Secondary outcomes (3)
change in serum high-mobility group box protein 1 (HMGB1)
blood sample will be collected at baseline and after 2 months
Measured: 2 months
change in serum Intestinal fatty acid binding protein (I-FABP).
blood sample will be collected at baseline and after 2 months
Measured: 2 months
change in serum total antioxidant capacity (TAC)
Blood sample will be collected at baseline and after 2 months
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start30 Jun 2022
- Primary completion1 Nov 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Necrotizing EnterocolitisStudies of the same condition, open and under way.
- More trials run by Tanta 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Mohamed Ahmed Rowisha, Tanta University
- Investigators
- Sahar Hegazy, MD, Study director, professor and head of clinical pharmacy department, faculty of Pharmact, Tanta University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06422000
- Sponsor's protocol ID
- pentoxifylline probiotic NEC
- Status last verified
- May 2024
- First submitted
- 11 Nov 2022
- Last updated
- 20 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pentoxifylline Versus Probiotic as Adjuvant Therapy for Preterm Neonates With Necrotizing Enterocolitis
- ClinicalTrials.gov ID
- NCT06422000
- Acronym / sponsor ID
- pentoxifylline probiotic NEC
- Conditions
- Necrotizing Enterocolitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 30 Jun 2022 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 20 May 2024 (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 aim of this study is to evaluate the effectiveness of pentoxifylline versus probiotics supplementation as adjuvant therapy for preterm neonates with necrotizing enterocolitis.
Detailed description
This randomized clinical trial includes 75 preterm infants who met the inclusion criteria for stage I and stage II NEC. Patients are allocated randomly into three groups (each included 25 neonates); group I (traditional therapy group) received antibiotics according to culture and sensitivity results, group II (pentoxifylline group) received antibiotics and IV pentoxifylline at a dose of 30 mg/ Kg given over 6 hours daily until discharge from the unit, and group III (probiotics group) received antibiotics and probiotics sachets supplementation in a dose of 100 mg mixed with 10 ml sterile water and given by Ryle tube once daily until discharge. The serum level of high-mobility group box protein 1 (HMGB-1), intestinal fatty acid binding proteins (I-FABP), and total antioxidant capacity (TAC) were measured on admission and at discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control group (group I) | No intervention | –will include 25 preterm neonates with NEC who will receive traditional therapy of NEC including antibiotics and normal incubator care measures |
| pentoxifylline group (group II) | Active comparator | Drug: Pentoxifyllinewill include 25 preterm neonates with NEC who will receive traditional therapy of NEC in association with IV pentoxifylline at a dose of 30 mg/kg given over 6 hours daily (Schüller et al., 2020) until discharge from the unit after clinical and laboratory improvement . |
| probiotic group (group III) | Active comparator | Drug: Probiotic Formulawill include 25 preterm neonates with NEC who will receive traditional therapy of NEC in association with probiotics sachets supplementation, in the form of lyophilized lactic acid bacteria each Aluminium stick pack contains 100 mg ( Meyer et al., 2020) Probio Tec BB12-Blend 30- IF* (SANDOZ®.) mixed with 10 ml sterile water and given by Ryle tube once daily until discharge from the unit after clinical and laboratory improvement . |
Who may qualify
- Ages
- Up to 37 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Male and female preterm neonates less than 37 weeks gestational age
- Suffering from necrotizing enterocolitis (NEC), according to Modified Bell's system which was first proposed by Bell et al., 1978 as stage I (suspected), II (proven) .
- Diagnosis of NEC depends on; history, physical examination, laboratory and radiographic findings .
- Signs and symptoms of NEC (at least three or more ), including; unstable temperature, apnea, increased residual milk in stomach, mid abdominal distension, vomiting coffee-like substances, bloody stool
- Laboratory findings including; thrombocytopenia, hypernatremia, metabolic acidosis, neutropenia and leukocytosis.
Key exclusion criteria (4 listed)
- Term and post term neonates
- Neonates with congenital infections
- Neonates with major congenital anomalies
- Neonates with stage III NEC
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 |
|---|---|---|
| PentoxifyllineAlso: group 2 (Pentoxifylline group)Pentoxifylline 30 mg/kg given over 6 hours daily | Drug | pentoxifylline group (group II) |
| Probiotic FormulaAlso: group 3 (Probiotic group)probiotics sachets supplementation, in the form of lyophilized lactic acid bacteria each Aluminium stick pack contains 100 mg ( Meyer et al., 2020) Probio Tec BB12-Blend 30- IF* (SANDOZ®.) mixed with 10 ml sterile water and given by Ryle tube once daily until discharge from the unit after clinical and laboratory improvement . | Drug | probiotic group (group III) |
Primary outcome
Mortality rate
Time frame: 2 months
record mortality rate in each group during treatment
complications and side effects
Time frame: 2 months
record any complications or side effects of the treating drugs
Inflammatory parameter
Time frame: 2 months
Change in serum C-reactive protein at baseline and after 2 months
3 secondary outcomes
change in serum high-mobility group box protein 1 (HMGB1)
Time frame: 2 months
change in serum Intestinal fatty acid binding protein (I-FABP).
Time frame: 2 months
change in serum total antioxidant capacity (TAC)
Time frame: 2 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 20 May 2024.
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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.
Sahar Hegazy, MD study director
professor and head of clinical pharmacy department, faculty of Pharmact, Tanta University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pentoxifylline and Probiotic Formula in people with Necrotizing Enterocolitis, run by Tanta 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 6 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 20 May 2024. 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. 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?
Mortality rate (time frame: 2 months). The study lists 3 primary outcomes in all. 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 20 May 2024.