A Multi-strain Synbiotic Versus a Multi-strain Probiotic in Premature Infants

This study has been withdrawn prior to enrollment.
(Pending further safety information regarding polysaccharides and premature infants)
Sponsor:
Information provided by:
University of Nebraska
ClinicalTrials.gov Identifier:
NCT01337921
First received: March 16, 2011
Last updated: June 24, 2011
Last verified: June 2011
  Purpose

The aims are to 1) compare two probiotic treatments (multi-strain synbiotic vs. multi-strain probiotic) on bifidobacteria fecal colonization counts at 1, 2, 3, and 4 weeks of life, 34 weeks corrected gestation age (CGA) ; 2) compare infants successfully colonized with probiotic organisms to infants not successfully colonized at 1, 2, 3, and 4 weeks of life, 34 weeks CGA on infant outcomes and on stress biomarker patterns at birth, day of life (DOL) 1, DOL 7; 3) determine long-term safety and outcomes of probiotic treatments at 6, 16, and 24 months CGA.


Condition Intervention
Feeding; Difficult, Newborn
Necrotizing Enterocolitis
Dietary Supplement: Multi-strain Probiotic

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial on a Multi-strain Synbiotic vs. a Multi-strain Probiotic on Fecal Colonization in the Very Low Birth Weight Infant

Resource links provided by NLM:


Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • compare a multi-strain synbiotic vs. a multi-strain probiotic on mean bifidobacteria fecal colonization counts [ Time Frame: 1 week of age ] [ Designated as safety issue: No ]
  • compare a multi-strain synbiotic vs. a multi-strain probiotic on mean bifidobacteria fecal colonization counts [ Time Frame: 2 weeks of age ] [ Designated as safety issue: No ]
  • compare a multi-strain synbiotic vs. a multi-strain probiotic on mean bifidobacteria fecal colonization counts [ Time Frame: 3 weeks of age ] [ Designated as safety issue: No ]
  • compare a multi-strain synbiotic vs. a multi-strain probiotic on mean bifidobacteria fecal colonization counts [ Time Frame: 4 weeks of age ] [ Designated as safety issue: No ]
  • compare a multi-strain synbiotic vs. a multi-strain probiotic on mean bifidobacteria fecal colonization counts [ Time Frame: 34 weeks corrected gestational age ] [ Designated as safety issue: No ]
    Infants will be given the synbiotic or probiotic supplementation within the first week of life (upon inititation of enteral feedings) until approximately 34 weeks corrected gestational age.


Secondary Outcome Measures:
  • Compare the difference between two groups (multi-strain synbiotic vs. multi-strain probiotic) on demographic data and selected standard clinical infant outcomes. [ Time Frame: From birth to NICU discharge (average 36 weeks corrected gestational age) ] [ Designated as safety issue: No ]
    Two probiotic groups will be compared on demographics: mean [birth wt(g), birth length(cm), birth hc(cm), GA at birth, 1-& 5- minute APGAR scores], race, gender, prenatal antibiotics(y/n), and enteral feeding type(breastmilk, formula, both); and on selected infant outcomes: Feeding Intolernce(number of times the feeding care plan is disrupted), NEC(y/n), late-onset sepsis(y/n), IVH(y/n;Grade I-IV), PDA(y/n), CLD(y/n), mean [endotracheal ventilation(days), inspired oxygen, discharge wt(g),discharge length(cm), discharge hc(cm), days to reach full feedings, length of stay, days on antibiotics].

  • Compare the difference bewteen infants successfully colonized with probiotic organisms (>10^2 colonies on a 10^4-fold dilution plate)to infants not successfully colonized on demographics and selected standard clinical outcomes [ Time Frame: 1 week of life to NICU discharge ] [ Designated as safety issue: No ]
    Two colonization groups will be compared on demographics: mean[birth wt(g), birth length(cm),birth hc(cm),GA at birth,1-& 5- minute APGAR scores],race, gender,prenatal antibiotics(y/n),and enteral feeding type(breastmilk, formula, both); and on selected infant outcomes: Feeding Intolernce(number of times the feeding care plan is disrupted), NEC(y/n), late-onset sepsis(y/n), IVH(y/n;Grade I-IV), PDA(y/n), CLD(y/n), mean [endotracheal ventilation(days), inspired oxygen, discharge wt(g),discharge length(cm), discharge hc(cm), days to reach full feedings, length of stay, days on antibiotics].

  • Compare infants successfully colonized with probiotic organisms(>10^2 colonies on a 10^4-fold dilution plate) to infants not successfully colonized on stress biomarker levels [ Time Frame: day of life 1 to day of life 7 ] [ Designated as safety issue: No ]
    Interquartile ranges of biomarkers will be compared between the two colonization groups. Biomarkers include: serum cortisol(cord blood), salivary cortisol (DOL 1,7), serum 8-hydroxydeoxyguanosine (cord blood), urinary 8-hydroxydeoxyguanosine (DOL 1,7)

  • Compare trends of stress biomarker levels in relation to demographics and selected standard infant outcomes [ Time Frame: day of life 1 to day of life 7 ] [ Designated as safety issue: No ]
    Interquartile ranges of biomarkers (listed above) will be compared on the demographic data and selected standard infant outcomes (listed above) at each time (DOL 1, 7) and over-time.

  • Compare the difference between the two probiotic treatment groups (multi-strain synbiotic vs. multi-strain probiotic) on longitudinal neurodevelopmental outcomes. [ Time Frame: 6 months corrected gestational age. ] [ Designated as safety issue: Yes ]
    Appropriate Bayley scales conducted by developmental pediatricians will be used for the neurodevelopmental data.

  • Compare the difference between the two probiotic treatment groups (multi-strain synbiotic vs. multi-strain probiotic) on longitudinal neurodevelopmental outcomes. [ Time Frame: 16 months corrected gestational age ] [ Designated as safety issue: No ]
    Appropriate Bayley scales conducted by developmental pediatricians will be used for the neurodevelopmental data.

  • Compare the difference between the two probiotic treatment groups (multi-strain synbiotic vs. multi-strain probiotic) on longitudinal neurodevelopmental outcomes. [ Time Frame: 24 months corrected gestational age ] [ Designated as safety issue: Yes ]
    Appropriate Bayley scales conducted by developmental pediatricians will be used for the neurodevelopmental data.


Estimated Enrollment: 30
Study Start Date: June 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Multi-strain Synbiotic
Multi-strain probiotic with prebiotics
Dietary Supplement: Multi-strain Probiotic
Multi-strain Synbiotic: 1.5 billion CFU of Lactobacillus acidophilus, Bifidobacterium bifidum,and Bifidobacterium lactis WITH galacto-oligosaccharide(GOS)/fructo-oligosaccharide (FOS) combination at 1g/dL (0.9g/dL GOS/ 0.1g/dL FOS)
Other Name: Lactobacillus
Active Comparator: Multi-strain Probiotic
Multi-strain Probiotic without prebiotics.
Dietary Supplement: Multi-strain Probiotic
Multi-strain Synbiotic: 1.5 billion CFU of Lactobacillus acidophilus, Bifidobacterium bifidum,and Bifidobacterium lactis WITH galacto-oligosaccharide(GOS)/fructo-oligosaccharide (FOS) combination at 1g/dL (0.9g/dL GOS/ 0.1g/dL FOS)
Other Name: Lactobacillus

Detailed Description:

Feeding Intolerance and other GI issues are a major concern in a NICU hospitalized population. Successful colonization with probiotic bacteria is thought to impact the incidence of GI related issues. This study will study the impact of prebiotics on the colonization of a population of VLBW infants in the NICU setting.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • infants with a birth weight < 1500g
  • admission to NICU at The Nebraska Medical Center

Exclusion Criteria:

  • infants who have congenital anomalies
  • have a diagnosis of a congenital metabolic disease
  • are made a ward of the State or
  • are born to a mother < 19 years of age
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01337921

Locations
United States, Nebraska
The Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: Ann Anderson-Berry, MD UNMC, the Nebraska Medical Center
Principal Investigator: Corrine K Hanson, PhD UNMC
  More Information

No publications provided

Responsible Party: Tiffany A Moore, RN, BSN, UNMC
ClinicalTrials.gov Identifier: NCT01337921     History of Changes
Other Study ID Numbers: 065-11-FB
Study First Received: March 16, 2011
Last Updated: June 24, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Enterocolitis
Enterocolitis, Necrotizing
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on April 17, 2014