Premature Infant Clinical Trial
— PREBIOMAOfficial title:
Effect of a Mixture of New Probiotic Strains in the Colonization of the Gastrointestinal Tract of Preterm Infants.
Verified date | October 2020 |
Source | ProbiSearch SL |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | December 31, 2019 |
Est. primary completion date | December 31, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A to 5 Days |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Universitario La Paz | Madrid |
Lead Sponsor | Collaborator |
---|---|
ProbiSearch SL |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Counts (CFU/g) of Bifidobacterium and Lactobacillus colonies from fecal samples. | Counts (CFU/g) of Bifidobacterium and Lactobacillus presents in fecal samples from preterm infants | 2 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT02550054 -
Erythropoietin in Premature Infants to Prevent Encephalopathy
|
Phase 2 | |
Completed |
NCT03827252 -
Respiratory Stability and Vegetative Coupling During Neonatal Skin-to-skin Care
|
||
Active, not recruiting |
NCT03345069 -
Cincinnati Infant Neurodevelopment Early Prediction Study (CINEPS)
|
||
Completed |
NCT04067206 -
The Effects Of Auditory Interventions On Pain And Comfort In Premature Infants
|
N/A | |
Completed |
NCT03911674 -
Effects of Oral Stimulation in Preterm Infants
|
Phase 3 | |
Completed |
NCT03324126 -
Individualized Fortification of Breast Milk
|
N/A | |
Completed |
NCT03704012 -
Efficacy of Massage Applied by the Parents in Hospitalized Premature Birth (PreMas)
|
N/A | |
Active, not recruiting |
NCT03241082 -
Ultrasound Assessment of BC in the NICU
|
||
Completed |
NCT02133716 -
Efficacy of Breast Milk Expressed and Sucrose in Procedural Pain in Preterm
|
Phase 4 | |
Not yet recruiting |
NCT05543005 -
Efficacy Study of an Audio Device Outside Incubator Allowing Broadcasting Maternal Voice on Stability in Preterm Infants
|
N/A | |
Recruiting |
NCT03852641 -
Feeding Premature Infants During Non-invasive Respiratory Support
|
N/A | |
Active, not recruiting |
NCT03423914 -
Efficacy of Expressive Writing in Mothers of Preterm Infants
|
N/A | |
Recruiting |
NCT04648787 -
A Study of Family-integrated Care for Reducing Uncertainty
|
N/A | |
Recruiting |
NCT04866342 -
Servo Controlled Oxygen Targeting (SCO2T) Study: Masimo vs. Nellcor
|
N/A | |
Not yet recruiting |
NCT02601872 -
Erythropoietin in Premature Infants to Prevent Encephalopathy
|
Phase 2 | |
Not yet recruiting |
NCT02534090 -
Evaluation of Feeding Intolerance in Premature Infants Using Near Infrared Spectroscopy
|
N/A | |
Recruiting |
NCT06212427 -
Feeding Tolerance and Growth of Preterm Infants Consuming a Supplement Containing Two Human Milk Oligosaccharides (HMOs)
|
N/A | |
Suspended |
NCT03939169 -
The Efficiency of Using Supportive Postures and Holding Techniques to Minimize Premature Infant Pain (PAP)
|
N/A | |
Completed |
NCT03706586 -
The Hilo Pilot -Trial to Assess Feasibility
|
N/A | |
Completed |
NCT03683316 -
Work of Breathing and Kangaroo Mother Care
|