Trial Outcomes & Findings for Effects of Probiotic and Prebiotic Combinations on Premature Infants (NCT NCT00282113)

NCT ID: NCT00282113

Last Updated: 2010-01-28

Results Overview

Weight at five weeks minus birth weight

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 90 participants
• Primary outcome timeframe: 5 weeks
• Results posted on: 2010-01-28

Participant Flow

Premature infants were enrolled from October 2004 to Aug 2006 at the University of California Davis Medical Center Neonatal Intensive Care Unit in Sacramento, California.

Participant milestones

Measure	ProBioPlus ProBioPlus (three bifidobacteria, Lactobacillus acidophilus, and fructo-oligosaccharide) at a dose of 5 x 10e8 organisms twice daily for five weeks	Culturelle Culturelle (Lactobacillus ramnosus GG plus fructo-oligosaccharide) at a dose of 5x10e8 organisms twice daily for five weeks.	Placebo A dilute preparation of pregestimil formula (negligible caloric content)
Overall Study STARTED	31	30	29
Overall Study COMPLETED	30	30	29
Overall Study NOT COMPLETED	1	0	0

Reasons for withdrawal

Measure	ProBioPlus ProBioPlus (three bifidobacteria, Lactobacillus acidophilus, and fructo-oligosaccharide) at a dose of 5 x 10e8 organisms twice daily for five weeks	Culturelle Culturelle (Lactobacillus ramnosus GG plus fructo-oligosaccharide) at a dose of 5x10e8 organisms twice daily for five weeks.	Placebo A dilute preparation of pregestimil formula (negligible caloric content)
Overall Study Removed at parents request	1	0	0

Baseline Characteristics

Effects of Probiotic and Prebiotic Combinations on Premature Infants

Baseline characteristics by cohort

Measure	ProBioPlus n=31 Participants ProBioPlus (three bifidobacteria, Lactobacillus acidophilus, and fructo-oligosaccharide) at a dose of 5 x 10e8 organisms twice daily for five weeks	Culturelle n=30 Participants Culturelle (Lactobacillus ramnosus GG plus fructo-oligosaccharide) at a dose of 5x10e8 organisms twice daily for five weeks.	Placebo n=29 Participants A dilute preparation of pregestimil formula (negligible caloric content)	Total n=90 Participants Total of all reporting groups
Age, Categorical <=18 years	31 Participants n=5 Participants	30 Participants n=7 Participants	29 Participants n=5 Participants	90 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age Continuous	29.3 weeks gestation STANDARD_DEVIATION 2.6 • n=5 Participants	29.5 weeks gestation STANDARD_DEVIATION 2.6 • n=7 Participants	30.2 weeks gestation STANDARD_DEVIATION 2.4 • n=5 Participants	29.7 weeks gestation STANDARD_DEVIATION 2.5 • n=4 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	9 Participants n=7 Participants	10 Participants n=5 Participants	31 Participants n=4 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	21 Participants n=7 Participants	19 Participants n=5 Participants	59 Participants n=4 Participants
Region of Enrollment United States	31 participants n=5 Participants	30 participants n=7 Participants	29 participants n=5 Participants	90 participants n=4 Participants

PRIMARY outcome

Timeframe: 5 weeks

Population: Infants left the study as they were discharged from the NICU, therefore many of the infants were not available for measurement at five weeks. The number reported is the number of infants remaining in the study at 5 weeks. Weight in grams is reported.

Weight at five weeks minus birth weight

Outcome measures

Measure	ProBioPlus n=19 Participants ProBioPlus (three bifidobacteria, Lactobacillus acidophilus, and fructo-oligosaccharide) at a dose of 5 x 10e8 organisms twice daily for five weeks	Culturelle n=15 Participants Culturelle (Lactobacillus ramnosus GG plus fructo-oligosaccharide) at a dose of 5x10e8 organisms twice daily for five weeks.	Placebo n=17 Participants A dilute preparation of pregestimil formula (negligible caloric content)
Weight Gain	618 Grams Standard Deviation 201	590 Grams Standard Deviation 186	682 Grams Standard Deviation 208

SECONDARY outcome

Timeframe: 4 weeks

Using standard culture techniques, we measured how many of the first 11 infants in each arm of the study grew bifidobacteria in their feces after four weeks of treatment.

Outcome measures

Measure	ProBioPlus n=11 Participants ProBioPlus (three bifidobacteria, Lactobacillus acidophilus, and fructo-oligosaccharide) at a dose of 5 x 10e8 organisms twice daily for five weeks	Culturelle n=11 Participants Culturelle (Lactobacillus ramnosus GG plus fructo-oligosaccharide) at a dose of 5x10e8 organisms twice daily for five weeks.	Placebo n=11 Participants A dilute preparation of pregestimil formula (negligible caloric content)
Stool Colonization With Bifidobacteria	7 Participants	2 Participants	3 Participants

SECONDARY outcome

Timeframe: 4 weeks

Outcome measures

Measure	ProBioPlus n=11 Participants ProBioPlus (three bifidobacteria, Lactobacillus acidophilus, and fructo-oligosaccharide) at a dose of 5 x 10e8 organisms twice daily for five weeks	Culturelle n=12 Participants Culturelle (Lactobacillus ramnosus GG plus fructo-oligosaccharide) at a dose of 5x10e8 organisms twice daily for five weeks.	Placebo n=10 Participants A dilute preparation of pregestimil formula (negligible caloric content)
Stool Short Chain Butyric Acid Content	5.1 nmoles per mg stool Standard Deviation 4.8	8.3 nmoles per mg stool Standard Deviation 5.6	7.7 nmoles per mg stool Standard Deviation 5.5

Adverse Events

ProBioPlus

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Culturelle

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mark A. Underwood MD

University of California Davis

Phone: 916-734-5061

Email: mark.underwood@ucdmc.ucdavis.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place