Premature Infant
Conditions
Brief summary
An interventional, randomized, double-blind, placebo-controlled study will be conducted to investigate the effect of a new probiotic strain Lactobacillus PS11603 & Bifidobacterium PS10402 in premature infants from 28 weeks + 0 days to 30 weeks + 6 days of gestation. The study duration will be 2 months, which includes 8 weeks product administration. Participants will be randomized assigned to one of the two study groups: the control group with placebo consumption and a probiotic consumption group.
Detailed description
An interventional, randomized, double-blind, placebo-controlled study will be conducted to investigate the effect of a new probiotic strains Lactobacillus PS11603 & Bifidobacterium PS10402 in 30 premature infants born within 28 weeks + 0 days to 30 weeks + 6 days of gestation. The duration of participation in the study is estimated to be 40-60 days. Participants will be randomized assigned to one of the two arms of the study: the control group, with placebo consumption, and a probiotic consumption group. The aim of the study will be investigate the effect of the probiotics strains in the colonization of the intestinal tract of preterm babies.
Interventions
DIETARY_SUPPLEMENTLactobacillus PS11603 & Bifidobacterium PS10402
Approximately 8 weeks intervention study: Participants with 0-5 days of age will start a period of 8 weeks of intervention. During this time the participants will intake one daily dose of the product that contains 1\*10E9 CFU of L.salivarius PS11603 and 1\*10E8 CFU of B.longum PS10402.
DIETARY_SUPPLEMENTPlacebo
8 weeks intervention study: A 8 weeks intervention period. During the 8 weeks of intervention the participants will intake one daily dose of placebo supplement.
Sponsors
ProbiSearch SL
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
This is an interventional, randomized, double-blind, placebo-controlled, parallel-group study.
Eligibility
Sex/Gender
ALL
Age
1 Minutes to 5 Days
Healthy volunteers
Yes
Inclusion criteria
* Preterm infants born between week 28 + 0 days and week 30 + 6 days of gestation. * Written informed consent signed by the parent or legal guardian. * Tolerate enteral feeding, at least 10mL / kg / day. * Postnatal age ≤ 5 days
Exclusion criteria
* Child with malformations * With short bowel syndrome or any surgery in the gastrointestinal tract * With defect in the intestinal epithelial barrier
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Counts (CFU/g) of Bifidobacterium and Lactobacillus colonies from fecal samples. | 2 months | Counts (CFU/g) of Bifidobacterium and Lactobacillus presents in fecal samples from preterm infants |
Countries
Spain
Outcome results
None listed