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

NCT01337921 | Withdrawn

• 1 other identifier: 0065-11-FB
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Feeding; Difficult, Newborn; Necrotizing Enterocolitis

Outcome Measures

Primary Outcomes (1)

• Comparing a multi-strain synbiotic vs. a multi-strain probiotic on mean bifidobacteria fecal colonization counts

  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.

  1,2, 3, 4 and 34 weeks of age

Secondary Outcomes (5)

• Compare the difference between two groups (multi-strain synbiotic vs. multi-strain probiotic) on demographic data and selected standard clinical infant outcomes.

  From birth to NICU discharge (average 36 weeks corrected gestational age)

• Compare the difference between 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

  1 week of life to NICU discharge

• 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

  day of life 1 to day of life 7

• Compare trends of stress biomarker levels in relation to demographics and selected standard infant outcomes

  day of life 1 to day of life 7

• Compare the difference between the two probiotic treatment groups (multi-strain synbiotic vs. multi-strain probiotic) on longitudinal neurodevelopmental outcomes.

  6, 16 & 24 months corrected gestational age.

Study Arms (2)

Multi-strain Synbiotic

EXPERIMENTAL

Multi-strain probiotic with prebiotics

Dietary Supplement: Multi-strain Probiotic

Multi-strain Probiotic

ACTIVE COMPARATOR

Multi-strain Probiotic without prebiotics.

Dietary Supplement: Multi-strain Probiotic

Interventions

Multi-strain Probiotic DIETARY_SUPPLEMENT

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)

Also known as: Lactobacillus

Multi-strain Probiotic; Multi-strain Synbiotic

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nebraska: lead

MeSH Terms

Conditions

Enterocolitis, Necrotizing

Interventions

Lacteol

Condition Hierarchy (Ancestors)

Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Ann Anderson-Berry, MD

  University of Nebraska

  STUDY CHAIR

• Corrine K Hanson, PhD

  UNMC

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2011
• First Posted: April 19, 2011
• Study Start: June 1, 2011
• Primary Completion: June 16, 2011
• Study Completion: June 16, 2011
• Last Updated: August 14, 2023

Record last verified: 2023-08