The probiotic Bifidobacterium breve strain BBG-01 admistered early to preterm infants to prevent infection, necrotising enterocolitis and death. - PIPS: Probiotics In Preterm babies Study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-003445-17-GB

Enrollment

1294

Registered

2009-04-09

Start date

2009-05-12

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Necrotising enterocolitis in the preterm baby Late-onset (>72h of age) blood stream infection in the preterm baby Death of preterm babies before discharge from hospital

Interventions

Product Name: Bifibobacterium breve strain BBG-01 freeze dried with corn starch Product Code: B breve BBG Pharmaceutical Form: Powder for oral suspension

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Preterm babies gestation at birth 23w+0d to 30w+6d less than 48h old at recruitment with written informed parental consent. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • A known lethal congenital abnormality. • Any known gastrointestinal malformation. • No realistic prospect of survival.

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine whether early administration of B breve BBG to preterm infants reduces the incidence of episodes of infection, necrotising enterocolitis and death.; Secondary Objective: To determine whether successful colonisation with B breve BBG at 2 weeks post-natal age and 36 weeks post-menstrual age reduces the incidence of episodes of infection, necrotising enterocolitis and death. To study determinants of successful colonisation with B breve BBG in those babies allocated to receive probiotic using logistic regression analysis. ; Primary end point(s): • Any baby with an episode of blood stream infection, with any organism other than a skin commensal, diagnosed on a sample of blood drawn more than 72 hours after birth and before 46 weeks post-menstrual age, death or discharge from hospital whichever is soonest. • Necrotising enterocolitis, Bell stage II or III • Death before discharge from hospital.	—

Measure

Time frame

Main Objective: To determine whether early administration of B breve BBG to preterm infants reduces the incidence of episodes of infection, necrotising enterocolitis and death.; Secondary Objective: To determine whether successful colonisation with B breve BBG at 2 weeks post-natal age and 36 weeks post-menstrual age reduces the incidence of episodes of infection, necrotising enterocolitis and death. To study determinants of successful colonisation with B breve BBG in those babies allocated to receive probiotic using logistic regression analysis. ; Primary end point(s): • Any baby with an episode of blood stream infection, with any organism other than a skin commensal, diagnosed on a sample of blood drawn more than 72 hours after birth and before 46 weeks post-menstrual age, death or discharge from hospital whichever is soonest. • Necrotising enterocolitis, Bell stage II or III • Death before discharge from hospital.

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Mar 12, 2026