NECNCT07233382
Assessing the Efficacy of Probiotics in Prevention of NEC in Preterm Babies
A study testing Probiotic and 10% dextrose in people with NEC and NEC - Necrotizing Enterocolitis, run by Hayatabad Medical Complex at 1 site in Pakistan.
Trial summary
The goal of the study is to check efficacy of probiotics in preventing necrotizing enterocolitis. The main questions would be if the preterm baby developed NEC or not. Read more about this study
- Who is it for?
- Ages Up to 1 dayHealthy volunteers can take part
- Conditions the study is for
- NEC, NEC - Necrotizing Enterocolitis
- What is being tested?
- Probiotic and 10% dextrose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 196 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2026to 30 Sep 2026
- Phase
- Interventional
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 1 day
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Male and female preterm infants with a gestational age less than 35 weeks.
- All indoor patients and outdoor patients who present within 24hrs of birth
Who cannot join
- • Infants with congenital or developmental gastrointestinal disorders for example omphalocele, malrotation, gastroschisis.
- Infants with severe sepsis or gastrointestinal bleeding on presentation
Trial locations and contacts
1 site in 1 country.
About this study
The goal of the study is to check efficacy of probiotics in preventing necrotizing enterocolitis. The main questions would be if the preterm baby developed NEC or not.
Read the detailed description
: In the last five years, many systematic reviews have shown the benefit of Probiotics in prevention of NEC and Sepsis in preterm babies but most of these studies have been done in the developed countries. Although the overall benefit has been tilted In favor of use of probiotic however a definitive consensus has not been reached due to inconsistencies in results. Moreover, the impact of multistrain probiotics in our particular population has not been studied, which provides the rationale for our research
- Conditions
- NEC, NEC - Necrotizing Enterocolitis
- Being tested
- Probiotic, 10% dextrose
- Medical subject headings
- Enterocolitis, Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDrug
Also called Multistrain Probiotic
All preterm babies <34 weeks Gestational age admitted within 24 hrs of life will be eligible for the study. Those full filling inclusion criteria and consenting to participate will be recruited. Consent will be obtained by team not caring for the patient. Each recruited patient will be assigned a case ID number. Based on the Randomization babies will be assigned to either the intervention group or control group.
Study group: Multistrain probiotic containing a mix of Lactobacillus and Bifidobacterium spp.
- Dose is 1 million international units (0.2ml or 5 drops) OD
- Started as soon as feed is in initiated
10% dextroseDrug
Also called Dextrose water
This will receive 10% DW as placebo
| Study group | Role | What they receive |
|---|---|---|
| Probiotic group - Intervention | Active comparator | This group will receive intervention Receives: Drug: Probiotic |
| Placebo | Placebo comparator | This group will receive 10% DW Receives: Drug: 10% dextrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who develop NEC on probiotic vs placebo
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start1 Apr 2026
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
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 NECStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hayatabad Medical Complex
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Romisa Romisa, MBBS, FCPS, Principal investigator, Hyatabad Medical Complex
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07233382
- Sponsor's protocol ID
- ERB # 2731
- Other IDs
- Agha Khan
- Status last verified
- Aug 2026
- First submitted
- 14 Nov 2025
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pammi M, Cope J, Tarr PI, Warner BB, Morrow AL, Mai V, Gregory KE, Kroll JS, McMurtry V, Ferris MJ, Engstrand L, Lilja HE, Hollister EB, Versalovic J, Neu J. Intestinal dysbiosis in preterm infants preceding necrotizing enterocolitis: a systematic review and meta-analysis. Microbiome. 2017 Mar 9;5(1):31. doi: 10.1186/s40168-017-0248-8.
PubMed 28274256