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This study has been withdrawn prior to enrollment.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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014