Necrotizing EnterocolitisPhase 2NECNCT04541771
The Role of Lactobacillus Reuteri in Preventing Necrotizing Enterocolitis (NEC) in Pre-term Infants
A Phase 2 study testing Lactobacillus Reuteri DSM 17938 in people with Necrotizing Enterocolitis and Sepsis, run by Children's Hospital and Institute of Child Health, Multan.
Trial summary
The purpose of this study is to compare the effectiveness of L. Reuteri with placebo in prevention of NEC in children, as according to my knowledge, there is limited work is done nationally and internationally. Probiotics are being used in our Children Hospital and the Institute of Child Health, Multan. Read more about this study
- Who is it for?
- Ages 28 to 34 weeksHealthy volunteers can take part
- Conditions the study is for
- Necrotizing Enterocolitis, Sepsis
- What is being tested?
- Lactobacillus Reuteri DSM 17938
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Oct 2020to Jan 2021
- Phase
- Phase 2
- 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 28 to 34 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Preterm neonate< 34 weeks and >28 weeks of gestation of both genders Hemodynamically stable
Who cannot join
- Preterm neonates >34 weeks gestational age < 28 weeks of gestation Cardiorespiratory illness Parental refusal
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Role of Lactobacillus Reuteri (L. Reuteri) in Preventing Necrotizing Enterocolitis (NEC) in Pre-term Infants Less Than 34 Weeks of Gestation
The purpose of this study is to compare the effectiveness of L. Reuteri with placebo in prevention of NEC in children, as according to my knowledge, there is limited work is done nationally and internationally. Probiotics are being used in our Children Hospital and the Institute of Child Health, Multan.
Route of administration of L. Reuteri will be oral or via nasogastric tube due to availability of oral form in Pakistan. The results of this study will be helpful to assess the beneficial effects of probiotics especially L. Reuteri in NEC in preterm. So, they can be recommended as preventive strategy to avoid NEC development and its complications based on its availability, effectivity and easy administration
- Conditions
- Necrotizing Enterocolitis, Sepsis
- Being tested
- Lactobacillus Reuteri DSM 17938, Placebo
- Keywords
- Necrotizing Enterocolitis,, lactobacillus reuteri ds 17938
- Medical subject headings
- Enterocolitis, Necrotizing, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus Reuteri DSM 17938Drug
The trial group will receive their usual feeds plus daily probiotic addition 1 drop/kg/dose twice daily added in expressed breast milk/formula milk from the beginning of enteral feedings till the baby attain full feeds
PlaceboDrug
expressed breast milk/formula milk plus normal saline drop from the beginning of enteral feedings till the baby attain full feeds
| Study group | Role | What they receive |
|---|---|---|
| drug group | Experimental | The trial group will receive their usual feeds plus daily probiotic (Lactobacillus Reuteri DSM 17938) addition 1 drop/kg/dose(. minimum of 20 million live Lactobacillus Reuteri are present in One drop) twice daily added in expressed breast milk/formula milk from the beginning of enteral feedings till the baby attain full feeds Receives: Drug: Lactobacillus Reuteri DSM 17938 |
| control group | Placebo comparator | this group is control group and will receive normal saline drops as 1 drop/kg/ dose mixed in enteral feed Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
narcotizing enterocolitis
number of participants with the sign of feeding intolerance (such as the gastric aspirate in the amount that was more than half of previous feeding), or with abdominal distension measured by increase in abdominal girth from base line,Bell Staging Criteria according to clinical and radio-logical signs
Measured: up to 35 weeks of gestation
Secondary outcomes (1)
sepsis
number of participants who developed sepsis proven by blood cultures before of after intervention
Measured: At time of addmission and 15 days after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study startOct 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionJan 2021 (estimated)
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.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- participants will be divided in two groups. one is control group and the other Interventional group. control group will receive the drug under study and control will be given placebo for the period of until they complete 35 weeks of gestation or discharged.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital and Institute of Child Health, Multan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr Summera Tabasum, Children's Hospital and Institute of Child Health, Multan
- Investigators
- summera tabasum, Principal investigator, CH&ICH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04541771
- Sponsor's protocol ID
- CH&ICH
- Acronym
- NEC
- Status last verified
- Sep 2020
- First submitted
- 5 Aug 2020
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Lactobacillus Reuteri (L. Reuteri) in Preventing Necrotizing Enterocolitis (NEC) in Pre-term Infants Less Than 34 Weeks of Gestation
- ClinicalTrials.gov ID
- NCT04541771
- Acronym / sponsor ID
- NEC / CH&ICH
- Conditions
- Necrotizing Enterocolitis, Sepsis
- Keywords
- Necrotizing Enterocolitis,, lactobacillus reuteri ds 17938
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Children's Hospital and Institute of Child Health, MultanOther government
- Study start
- Oct 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 9 Sep 2020 (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 purpose of this study is to compare the effectiveness of L. Reuteri with placebo in prevention of NEC in children, as according to my knowledge, there is limited work is done nationally and internationally. Probiotics are being used in our Children Hospital and the Institute of Child Health, Multan.
Route of administration of L. Reuteri will be oral or via nasogastric tube due to availability of oral form in Pakistan. The results of this study will be helpful to assess the beneficial effects of probiotics especially L. Reuteri in NEC in preterm. So, they can be recommended as preventive strategy to avoid NEC development and its complications based on its availability, effectivity and easy administration
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- participants will be divided in two groups. one is control group and the other Interventional group. control group will receive the drug under study and control will be given placebo for the period of until they complete 35 weeks of gestation or discharged.
| Arm | Type | Receives |
|---|---|---|
| drug group | Experimental | Drug: Lactobacillus Reuteri DSM 17938The trial group will receive their usual feeds plus daily probiotic (Lactobacillus Reuteri DSM 17938) addition 1 drop/kg/dose(. minimum of 20 million live Lactobacillus Reuteri are present in One drop) twice daily added in expressed breast milk/formula milk from the beginning of enteral feedings till the baby attain full feeds |
| control group | Placebo comparator | Drug: Placebothis group is control group and will receive normal saline drops as 1 drop/kg/ dose mixed in enteral feed |
Who may qualify
- Ages
- 28 to 34 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Preterm neonate< 34 weeks and >28 weeks of gestation of both genders Hemodynamically stable
Key exclusion criteria (1 listed)
- Preterm neonates >34 weeks gestational age < 28 weeks of gestation Cardiorespiratory illness Parental refusal
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 |
|---|---|---|
| Lactobacillus Reuteri DSM 17938The trial group will receive their usual feeds plus daily probiotic addition 1 drop/kg/dose twice daily added in expressed breast milk/formula milk from the beginning of enteral feedings till the baby attain full feeds | Drug | drug group |
| Placeboexpressed breast milk/formula milk plus normal saline drop from the beginning of enteral feedings till the baby attain full feeds | Drug | control group |
Primary outcome
narcotizing enterocolitis
Time frame: up to 35 weeks of gestation
number of participants with the sign of feeding intolerance (such as the gastric aspirate in the amount that was more than half of previous feeding), or with abdominal distension measured by increase in abdominal girth from base line,Bell Staging Criteria according to clinical and radio-logical signs
1 secondary outcome
sepsis
Time frame: At time of addmission and 15 days after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
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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.
summera tabasum principal investigator
CH&ICH
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lactobacillus Reuteri DSM 17938 in people with Necrotizing Enterocolitis and Sepsis, run by Children's Hospital and Institute of Child Health, Multan.
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 1 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: status not confirmed, as of the sponsor's last update on 9 Sep 2020. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact STabasum (03417236837, dr.sumeratabasum@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
narcotizing enterocolitis (time frame: up to 35 weeks of gestation). 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 9 Sep 2020.