Probiotic in Preterm Babies Use & AbusePro-pre-babNCT07910344
Probiotics in Preterm Babies Use & Abuse
An observational study of Probiotic in Preterm Babies Use & Abuse and Uses, run by Norhan Mohamed Abdelrady.
Trial summary
This is observational study conducted at sohag univeristy hospital to asses the clinical presentation, To evaluate all aspect of using probiotics in preterm(efficacy, lowering of sepsis, lowering necrotizing enterocolitis, failure, complications( use ,mis use ,abuse) Read more about this study
- Who is it for?
- Ages 1 day to 30 days
- Conditions the study is for
- Probiotic in Preterm Babies Use & Abuse, Uses, Side Effect
- What is being tested?
- Probiotic
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Preterm neonate <37 W, sohag univeristy hospital, egypt
Who may be able to join
- preterm infants <37 W gastational age Birth weight < 2500 gm. Infants able to tolerate oral feed and survive beyond 48hours
Who cannot join
- sick preterm neonate with Npo Preterm with major congenital anomalies Preterm suspected clinical sepsis
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This is observational study conducted at sohag univeristy hospital to asses the clinical presentation, To evaluate all aspect of using probiotics in preterm(efficacy, lowering of sepsis, lowering necrotizing enterocolitis, failure, complications( use ,mis use ,abuse)
Read the detailed description
To evaluate all aspect of using probiotics in preterm(efficacy, lowering of sepsis, lowering necrotizing enterocolitis, failure, complications( use ,mis use ,abuse) Preterm infants <37w gastational age Birth weight <2500gm Infant able to tolerate oral feed and survive beyond 48hours
- Conditions
- Probiotic in Preterm Babies Use & Abuse, Uses, Side Effect
- Being tested
- Probiotic
- Keywords
- Pro-pre-bab, Probiotic, In preterm, Babies, Uses, Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDrug
Type of probiotic Bacillus clausii Lacto Bacillus rhamnosus
| Study group | Role | What they receive |
|---|---|---|
| Preterm babies <37w with out several cong anaomaly, sepsis | No experimental intervention data willbe collected from routine clinical care, medical records and follow up visits according to standard hospital protocol Receives: Drug: Probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probiotic in preterm babies use & abuse
Probiotics in preterm babies use \& abuse,
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start1 Oct 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Probiotic in Preterm Babies Use & AbuseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Norhan Mohamed Abdelrady
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Norhan Mohamed Abdelrady, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07910344
- Sponsor's protocol ID
- Soh-Med-26-9-7MS
- Acronym
- Pro-pre-bab
- Status last verified
- Sep 2026
- First submitted
- 26 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to patient privacy and data protection pollicies at sohag univeristy hospital
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotics in Preterm Babies Use & Abuse
- ClinicalTrials.gov ID
- NCT07910344
- Acronym / sponsor ID
- Pro-pre-bab / Soh-Med-26-9-7MS
- Conditions
- Probiotic in Preterm Babies Use & Abuse, Uses, Side Effect
- Keywords
- Pro-pre-bab, Probiotic, In preterm, Babies, Uses, Abuse
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Norhan Mohamed AbdelradyUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 2 Nov 2026 (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.
This is observational study conducted at sohag univeristy hospital to asses the clinical presentation, To evaluate all aspect of using probiotics in preterm(efficacy, lowering of sepsis, lowering necrotizing enterocolitis, failure, complications( use ,mis use ,abuse)
Detailed description
To evaluate all aspect of using probiotics in preterm(efficacy, lowering of sepsis, lowering necrotizing enterocolitis, failure, complications( use ,mis use ,abuse) Preterm infants <37w gastational age Birth weight <2500gm Infant able to tolerate oral feed and survive beyond 48hours
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preterm babies <37w with out several cong anaomaly, sepsis | – | Drug: ProbioticNo experimental intervention data willbe collected from routine clinical care, medical records and follow up visits according to standard hospital protocol |
Who may qualify
- Ages
- 1 day to 30 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Preterm neonate <37 W, sohag univeristy hospital, egypt
Key inclusion criteria (1 listed)
- preterm infants <37 W gastational age Birth weight < 2500 gm. Infants able to tolerate oral feed and survive beyond 48hours
Key exclusion criteria (1 listed)
- sick preterm neonate with Npo Preterm with major congenital anomalies Preterm suspected clinical sepsis
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 |
|---|---|---|
| ProbioticType of probiotic Bacillus clausii Lacto Bacillus rhamnosus | Drug | Preterm babies <37w with out several cong anaomaly, sepsis |
Primary outcome
Probiotic in preterm babies use & abuse
Time frame: 1 year
Probiotics in preterm babies use \& abuse,
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Sohag univeristy hospital, department of pediatericLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to patient privacy and data protection pollicies at sohag univeristy hospital
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Probiotic in Preterm Babies Use & Abuse and Uses, run by Norhan Mohamed Abdelrady.
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: opening soon, as of the sponsor's last update on 2 Nov 2026. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nourhan Mohamed, Master (01090430453 ext. 01032366753, norhan.abdelrady@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probiotic in preterm babies use & abuse (time frame: 1 year). 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 2 Nov 2026.