Dual strain probiotics, Bifidobacterium bifidum and Lactobacillus acidophilus, reverse gut dysbiosis in preterm neonates: a randomized controlled trial

Randomized controlled trial comparing gut microbiota of preterm neonates receiving probiotics Bifidobacterium bifidum/Lactobacillus acidophilus (BB/LA) versus not receiving

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

TCTR

Registry ID

TCTR20220829005

Enrollment

Registered

2022-08-29

Start date

2022-07-01

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Gut microbiota dysbiosis in preterm neonates. Gut dysbiosis, gut microbiota, preterm neonates, probiotics, Bifidobacterium bifidum, Lactobacillus acidophilus

Interventions

Probiotics named Infloran 1 capsule(250mg) is tube-fed to the participant once a day before feeding milk. The feeding of Infloran starts approximately 24 hours after trophies feeding until the day of

Active Comparator Dietary Supplement,No Intervention No treatment

Probiotics

B. bifidum and L. acidophilus,Control

not receiving probiotics

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Preterm newborns gestational age of less than 33weeks or birth weight less than 1500 grams

Exclusion criteria

Exclusion criteria: 1. Suspected or confirmed chromosomal abnormalities 2. Cyanotic congenital heart disease 3. Suspected or confirmed congenital gastrointestinal tract anomalies

Design outcomes

Primary

Measure	Time frame
Gut microbiota profile at birth, post-menstrual age of 35 weeks, 4 months of age Alpha diversity: Shannon index, ACE, SImpson index, Chao 1,Gut microbiota profile at birth, post-menstrual age of 35 weeks, 4 months of age Relative abundances of Bifidobacterium, Lactobacillus, Clostridium, Staphylococcus, Klebsiella, Escherichia-Shigella,Gut microbiota profile at birth, post-menstrual age of 35 weeks, 4 months of age Beta diversity: Bray-Curtis dissimilarity	—

Measure

Time frame

Gut microbiota profile at birth, post-menstrual age of 35 weeks, 4 months of age Alpha diversity: Shannon index, ACE, SImpson index, Chao 1,Gut microbiota profile at birth, post-menstrual age of 35 weeks, 4 months of age Relative abundances of Bifidobacterium, Lactobacillus, Clostridium, Staphylococcus, Klebsiella, Escherichia-Shigella,Gut microbiota profile at birth, post-menstrual age of 35 weeks, 4 months of age Beta diversity: Bray-Curtis dissimilarity

—

Secondary

Measure	Time frame
Necrotizing enterocolitis during hospitalization Incidence,Late onset neonatal sepsis during hospitalization Incidence,death until 4 month of age incidence,length of stay during hospitalization days	—

Countries

Thailand

Contacts

Public ContactPornthep Tunpowpong

Faculty of medicine Ramathibodi hospital, Mahidol University

tuinoi1@gmail.com0806219353

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026