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The purpose of this study is to see how oral preparations containing both probiotics and prebiotics impact the growth, bacterial colonization of the intestines, and fecal short chain fatty acid content in premature infants. Our hypothesis is that short term growth will be improved, the stool will have more healthy bacteria, and the fecal short chain fatty acid content will increase in the babies who receive the probiotic/prebiotic combinations compared to control groups.
Premature infants are at risk for a devastating infection of the intestines due to the immaturity of their intestines and immune system. Probiotics are bacteria with healthful qualities that are taken by mouth to improve the number of healthy bacteria in the intestines. Probiotics have been shown in several studies outside the U.S. to decrease the risk of serious intestinal infection and in one small study to improve the rate of weight gain in premature infants. Prebiotics are food supplements that stimulate the growth of healthy bacteria and suppress the growth of unhealthy bacteria. Prebiotics have been shown to improve the numbers of healthy bacteria in the stool of premature babies. Our study is designed to compare two over the counter probiotic/prebiotic combinations to each other and to a control group. Infants less than 35 weeks with a birthweight of 750-2000 gm are eligible and must be enrolled in the study within the first week of life. The babies are randomly assigned to either a control group (no probiotic/prebiotic, just a placebo), a group which receives Culturelle (Lactobacillus rhamnosus GG plus fructo-oligosaccharide, ConAgra), or a group which receives ProBioPlus (three strains of Bifidobacteria plus Lactobacillus acidophilus plus fructo-oligosaccharide, UAS Laboratories). The babies receive the study product by mouth twice daily for 28 days or until discharge (whichever comes first). Weekly measurements (weight, length, head size) and stool cultures are performed. Clinical progress is closely monitored and any episodes of infection are recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ProBioPlus | Active Comparator |
| |
| Culturelle | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ProBioPlus | Dietary Supplement | ProBioPlus is advertised as containing Lactobacillus acidophilus, Bifidobacterium longum, Bifidobacterium infantis, and Bifidobacterium bifidum plus inulin. The dose given was 5 x 10e8 twice daily. |
| Measure | Description | Time Frame |
|---|---|---|
| Weight Gain | Weight at five weeks minus birth weight | 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Stool Colonization With Bifidobacteria | 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. | 4 weeks |
| Stool Short Chain Butyric Acid Content |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael P Sherman, MD | University of California, Davis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Davis Medical Center | Sacramento | California | 95817 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19179885 | Result | Underwood MA, Salzman NH, Bennett SH, Barman M, Mills DA, Marcobal A, Tancredi DJ, Bevins CL, Sherman MP. A randomized placebo-controlled comparison of 2 prebiotic/probiotic combinations in preterm infants: impact on weight gain, intestinal microbiota, and fecal short-chain fatty acids. J Pediatr Gastroenterol Nutr. 2009 Feb;48(2):216-25. doi: 10.1097/MPG.0b013e31818de195. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | ProBioPlus | ProBioPlus (three bifidobacteria, Lactobacillus acidophilus, and fructo-oligosaccharide) at a dose of 5 x 10e8 organisms twice daily for five weeks |
| FG001 | Culturelle | Culturelle (Lactobacillus ramnosus GG plus fructo-oligosaccharide) at a dose of 5x10e8 organisms twice daily for five weeks. |
| FG002 | Placebo | A dilute preparation of pregestimil formula (negligible caloric content) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ProBioPlus | ProBioPlus (three bifidobacteria, Lactobacillus acidophilus, and fructo-oligosaccharide) at a dose of 5 x 10e8 organisms twice daily for five weeks |
| BG001 | Culturelle |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Weight Gain | Weight at five weeks minus birth weight | 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. | Posted | Mean | Standard Deviation | Grams | 5 weeks |
|
Five weeks
We found no adverse events that could be attributed to the intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ProBioPlus | ProBioPlus (three bifidobacteria, Lactobacillus acidophilus, and fructo-oligosaccharide) at a dose of 5 x 10e8 organisms twice daily for five weeks |
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Smaller sample size than anticipated due to the number of infants enrolled who were discharged home prior to completing five weeks of treatment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark A. Underwood MD | University of California Davis | 916-734-5061 | mark.underwood@ucdmc.ucdavis.edu |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Culturelle | Dietary Supplement | Culturelle is advertised as containing Lactobacillus rhamnosus GG. The dose was 5 x 10e8 twice daily. |
|
| Placebo | Other | A dilute preparation of pregestimil powder formulated to have a similar appearance to the probiotic products |
|
| 4 weeks |
Culturelle (Lactobacillus ramnosus GG plus fructo-oligosaccharide) at a dose of 5x10e8 organisms twice daily for five weeks.
| BG002 | Placebo | A dilute preparation of pregestimil formula (negligible caloric content) |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | weeks gestation |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Placebo | A dilute preparation of pregestimil formula (negligible caloric content) |
|
|
|
| Secondary | Stool Colonization With Bifidobacteria | 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. | Posted | Number | Participants | 4 weeks |
|
|
|
|
| Secondary | Stool Short Chain Butyric Acid Content | Posted | Mean | Standard Deviation | nmoles per mg stool | 4 weeks |
|
|
|
|
| 0 |
| 31 |
| 0 |
| 31 |
| EG001 | Culturelle | Culturelle (Lactobacillus ramnosus GG plus fructo-oligosaccharide) at a dose of 5x10e8 organisms twice daily for five weeks. | 0 | 30 | 0 | 30 |
| EG002 | Placebo | A dilute preparation of pregestimil formula (negligible caloric content) | 0 | 29 | 0 | 29 |
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| D000091642 | Urogenital Diseases |