Progress 08/01/08 to 01/31/11
Outputs
OUTPUTS: Study to Investigate the Potential of Probiotics in Yogurt (The SIPPY II Study) This was a placebo-controlled randomized study in which the goal was to determine if a yogurt drink containing Bifidobacterium Lactis (BB-12) can reduce illness related daycare absences in children ages 2 to 4. The participants consumed daily 4 oz. of either the active intervention or the placebo for 90 consecutive days. During this period, participants were instructed to not drink or eat any other yogurts or probiotic containing foods, nor were they to consume any probiotic containing foods for 15 days after the last study drink was consumed. To disseminate the Study, we conducted informative presentations at daycares, community health centers, and Head Start centers in the DC metropolitan area. At the presentations we explained the topic, scope, purpose and process of the Study. We later informed parents to a greater depth on their role in the Study by explaining the contents of a Study information and resource packet given to parents on the day of their enrollment. The packet contains an informed consent, a HIPAA form, contact information, a demographic information survey, a baseline health status survey, daily diaries for parents to fill out, stool collection instructions, and compensation options. At enrollment we explained each one of these forms and answered any questions that arose. We customized presentations according to the audience's time, and when necessary, gave presentations in Spanish as well as English. We also set up booths at different daycares in the DC metropolitan area were we engaged parents with fliers and conversation about the Study as parents dropped off or picked up their children. We first screened potential participants by making sure that they qualified for the Study with an inclusion criteria form. We stated we would contact them to set up a meeting for the enrollment if they qualified. We have been conducting bi-weekly assessments, usually by phone, with the parents that enrolled in the study. Parents also record their child's health information on a daily diary. We collected stool before they started with the Intervention, and then on Days 45 and 105. Results have been presented at SupplySide West Conference (Las Vegas, NV, October 2010), the Sixth International Symposium, "Probiotics and Health: Key Findings, New Directions" (Montreal, Canada, October 2010), International Scientific Association for Probiotics and Prebiotics Meeting (Barcelona, Spain, August 2010). Results were also presented at The European Society of Paediatric Gastroenterology, Hepatology and Nutrition Annual Meeting (Sorrento, Italy, May 2011). PARTICIPANTS: The Principal Investigator, Daniel Merenstein, MD oversaw the entire project including management of the IRB process, recruitment, retention of participants and product transfer. He worked with the project coordinator, research assistants, medical students, and collaborators in order to ensure that the project was completed in a timely fashion. There were two Project Coordinators for the study; Amy Guimaraes was the Project Coordinator from July 1, 2008 to April 17, 2008. Jessy Gonzalez began on April 17, 2008 and was the Project Coordinator until end of the project. The Project Coordinators were responsible for supervising the Research Assistants and students. The Project Coordinators worked with the Capital Area Primary Care Research Network (CAPRICORN) offices to prepare for clinical aspects of the study, helped with the recruitment for the project, monitored the IRB process, and acted as the primary liaison to offices in the research. Additionally, the Project Coordinators and research assistants conducted informed consents, recruited participants, worked with data entry and ensured that the interventions were delivered in a timely fashion. They were also responsible of coordinating product and stool transfer between Pennsylvania State University and Georgetown University. TARGET AUDIENCES: During recruitment, we aimed to have participants with a variety of backgrounds. Participants were recruited from the DC Metropolitan area, daycare centers or schools, within the Capital Area Primary Care Research Network (CAPRICORN), and the Georgetown University clinical trial website. We recruited participants from various social, economic and educational backgrounds and have participants that are both Spanish and English speakers. PROJECT MODIFICATIONS: Not relevant to this project.
Impacts
After full recruitment, there were a total of 151 families and 172 children represented in the study. All researchers, the Principal Investigator, statisticians and the participants were blinded. Group A was the placebo group and Group B was the active group. More parents in active group have reported adverse events that they thought were possibly associated with the drink; there were more reports of diarrhea and loose stools in the active group. All demographics in both groups were roughly equal. Randomization worked appropriately in that there were no significant differences in the baseline characteristics between the two groups. Both groups experienced less illness and missed less school than historical cohorts have reported. The primary outcome, missed days of school due to illness per 100 days, was similar in both the active (2.54 days absent/100 school days) and control groups (2.42 days absent/100 school days) (p=0.873). There were also no significant differences among the secondary outcomes measured in the study, Parents in the active group reported 0.79 missed days of work/100 days compared to 0.94 in the control group (p=0.552). Runny nose was the most common symptom, with rates of 12.25 days affected/100 days reported in the active group and 14.26 days affected/100 days in the control group (p=0.458). A child was defined as compliant if he consumed one-half or more of a drink on each of the 14 days. The difference in compliance between the active group (93%) and the placebo group (88%) was not significant (p= 0.305). Our randomized clinical trial showed that BB-12 fortified yogurt is safe and well tolerated in children 2-4 years old but did not reduce daycare absences or illnesses. We believe it is crucial for other probiotic products on the market to be tested independently and in patient-oriented settings. Although this study does not support the value of this probiotic yogurt in reducing absences from day care or school, it does demonstrate that the product is well-tolerated, that viable counts can remain high for prolonged periods of time, and that compliance is extremely high with this mode of ingestion. This article was published in the European Journal of Clinical Nutrition. We are currently preparing another manuscript for publication with combined data from this study and a previous study of 1-3 year old children who consumed the same intervention. We have also submitted an R34 grant to the NIH to investigate the same probiotic drink studied in SIPPY II. The aims of the proposed project is to conduct a pediatric single arm antibiotic-associate diarrhea study to establish the safety of BB-12 fortified yogurt in children taking antibiotics. Secondary aims are to measure the rate of diarrhea in children consuming BB-12 yogurt while taking antibiotics and to examine the microbiome over time of children consuming both probiotics and antibiotics.
Publications
- Merenstein D, Gonzalez J, Young AG, Roberts RF, Sanders ME, Petterson S. Study to investigate the potential of probiotics in children attending school. Eur J Clin Nutr. 2011 Apr;65(4):447-53. Epub 2011 Feb 16.
|
Progress 08/01/09 to 07/31/10
Outputs
OUTPUTS: Study to Investigate the Potential of Probiotics in Yogurt (The SIPPY II Study) -- This was a placebo-controlled randomized study in which the goal was to determine if a yogurt drink containing Bifidobacterium Lactis (BB-12) can reduce illness related daycare absences in children ages 2 to 4. The participants consumed daily 4 oz. of either the active intervention or the placebo for 90 consecutive days. During this period, participants were instructed to not drink or eat any other yogurts or probiotic containing foods, nor were they to consume any probiotic containing foods for 15 days after the last study drink was consumed. To disseminate the Study, we conducted informative presentations at daycares, community health centers, and Head Start centers in the DC metropolitan area. At the presentations we explained the topic, scope, purpose and process of the Study. We later informed parents to a greater depth on their role in the Study by explaining the contents of a Study information and resource packet given to parents on the day of their enrollment. The packet contains an informed consent, a HIPAA form, contact information, a demographic information survey, a baseline health status survey, daily diaries for parents to fill out, stool collection instructions, and compensation options. At enrollment we explained each one of these forms and answered any questions that arose. We customized presentations according to the audience's time, and when necessary, gave presentations in Spanish as well as English. We also set up booths at different daycares in the DC metropolitan area were we engaged parents with fliers and conversation about the Study as parents dropped off or picked up their children. We first screened potential participants by making sure that they qualified for the Study with an inclusion criteria form. We stated we would contact them to set up a meeting for the enrollment if they qualified. We have been conducting bi-weekly assessments, usually by phone, with the parents that enrolled in the study. Parents also record their child's health information on a daily diary. We collected stool before they started with the Intervention, and then on Days 45 and 105. Results have been presented at SupplySide West Conference (Las Vegas, NV, October 2010), the Sixth International Symposium, "Probiotics and Health: Key Findings, New Directions" (Montreal, Canada, October 2010), International Scientific Association for Probiotics and Prebiotics Meeting (Barcelona, Spain, August 2010). Results will also be presented at The European Society of Paediatric Gastroenterology, Hepatology and Nutrition Annual Meeting (Sorrento, Italy, May 2011). PARTICIPANTS: The Principal Investigator, Daniel Merenstein, MD oversaw the entire project including management of the IRB process, recruitment, retention of participants and product transfer. He worked with the project coordinator, research assistants, medical students, and collaborators in order to ensure that the project was completed in a timely fashion. There were two Project Coordinators for the study; Amy Guimaraes was the Project Coordinator from July 1, 2008 to April 17, 2008. Jessy Gonzalez began on April 17, 2008 and was the Project Coordinator until end of the project. The Project Coordinators were responsible for supervising the Research Assistants and students. The Project Coordinators worked with the Capital Area Primary Care Research Network (CAPRICORN) offices to prepare for clinical aspects of the study, helped with the recruitment for the project, monitored the IRB process, and acted as the primary liaison to offices in the research. Additionally, the Project Coordinators and research assistants conducted informed consents, recruited participants, worked with data entry and ensured that the interventions were delivered in a timely fashion. They were also responsible of coordinating product and stool transfer between Pennsylvania State University and Georgetown University. TARGET AUDIENCES: During recruitment, we aimed to have participants with a variety of backgrounds. Participants were recruited from the DC Metropolitan area, daycare centers or schools, within the Capital Area Primary Care Research Network (CAPRICORN), and the Georgetown University clinical trial website. We recruited participants from various social, economic and educational backgrounds and have participants that are both Spanish and English speakers. PROJECT MODIFICATIONS: Nothing significant to report during this reporting period.
Impacts
After full recruitment, there were a total of 151 families and 172 children represented in the study. All researchers, the Principal Investigator, statisticians and the participants were blinded. Group A was the placebo group and Group B was the active group. More parents in active group have reported adverse events that they thought were possibly associated with the drink; there were more reports of diarrhea and loose stools in the active group. All demographics in both groups were roughly equal. Randomization worked appropriately in that there were no significant differences in the baseline characteristics between the two groups. Both groups experienced less illness and missed less school than historical cohorts have reported. The primary outcome, missed days of school due to illness per 100 days, was similar in both the active (2.54 days absent/100 school days) and control groups (2.42 days absent/100 school days) (p=0.873). There were also no significant differences among the secondary outcomes measured in the study, Parents in the active group reported 0.79 missed days of work/100 days compared to 0.94 in the control group (p=0.552). Runny nose was the most common symptom, with rates of 12.25 days affected/100 days reported in the active group and 14.26 days affected/100 days in the control group (p=0.458). A child was defined as compliant if he consumed one-half or more of a drink on each of the 14 days. The difference in compliance between the active group (93%) and the placebo group (88%) was not significant (p= 0.305). Our randomized clinical trial showed that BB-12 fortified yogurt is safe and well tolerated in children 2-4 years old but did not reduce daycare absences or illnesses. We believe it is crucial for other probiotic products on the market to be tested independently and in patient-oriented settings. Although this study does not support the value of this probiotic yogurt in reducing absences from day care or school, it does demonstrate that the product is well-tolerated, that viable counts can remain high for prolonged periods of time, and that compliance is extremely high with this mode of ingestion. This manuscript is under review at the European Journal of Clinical Nutrition. We are currently preparing another manuscript for publication with combined data from this study and a previous study of 1-3 year old children who consumed the same intervention. We have also submitted an R34 grant to the NIH to investigate the same probiotic drink studied in SIPPY II. The aims of the proposed project is to conduct a pediatric single arm antibiotic-associate diarrhea study to establish the safety of BB-12 fortified yogurt in children taking antibiotics. Secondary aims are to measure the rate of diarrhea in children consuming BB-12 yogurt while taking antibiotics and to examine the microbiome over time of children consuming both probiotics and antibiotics.
Publications
- No publications reported this period
|
Progress 08/01/08 to 07/31/09
Outputs
OUTPUTS: Study to Investigate the Potential of Probiotics in Yogurt (The SIPPY II Study) We are conducting a placebo-controlled randomized study in which the goal is to determine if a yogurt drink containing Bifidobacterium Lactis (BB-12) can reduce illness related daycare absences in children ages 2 to 4. The participants consumed daily 4 oz. of either the active intervention or the placebo for 90 consecutive days. During this period, participants are instructed to not drink or eat any other yogurts or probiotic containing foods, nor are they to consume any probiotic containing foods for 15 days after the last study drink was consumed. To disseminate the Study, we conducted informative presentations at daycares in the DC metropolitan area. At the presentations we explained the topic, scope, purpose and process of the Study. We later informed parents to a greater depth on their role in the Study by explaining the contents of a Study information and resource packet given to parents on the day of their enrollment. The packet contains an informed consent, a HIPPA form, contact information, a demographic information survey, a baseline health status survey, daily diaries for parents to fill out, stool collection instructions, and compensation options. At enrollment we explained each one of these forms and answered any questions that arose. We customized presentations according to the audience's time, and when necessary, gave presentations in Spanish as well as English. We also set up booths at different daycares in the DC metropolitan area were we engaged parents with fliers and conversation about the Study as parents dropped off or picked up their children. We first screened potential participants by making sure that they qualified for the Study with an inclusion criteria form. We stated we would contact them to set up a meeting for the enrollment if they qualified. We have been conducting bi-weekly assessments, usually by phone, with the parents that enrolled in the study. Parents also record their child's health information on a daily diary. We collected stool before they started with the Intervention, and then on Days 45 and 105. PARTICIPANTS: The Project Coordinator, Daniel Merenstein, MD oversees the entire project including management of the IRB process, recruitment, retention of participants and product transfer. He also works with the project coordinator, research assistants, medical students, and collaborators in order to ensure that the project is completed in a timely fashion. There were two Project Coordinators on the study. Amy Guimaraes was the Project Coordinator from July 1, 2008 until April 17, 2008, and Jessy Gonzalez began on April 17, 2008 and is the present Project Coordinator. Jessy previously worked as the Project Assistant. Both Project Coordinators were responsible for working closely with the Faculty Scholar. The Project Coordinators worked with the Capital Area Primary Care Research Network (CAPRICORN) offices to prepare for clinical aspects of the study, helped with the recruitment for the pilot project, monitored the IRB process, and acted as the primary liaison to offices in the research network once the clinical aspect of the study started. Additionally, the Project Coordinators conducted informed consents, recruited participants, worked with data entry and ensured that the interventions were delivered in a timely fashion. This position was also responsible of coordinating product and stool transfer between Pennsylvania State University and Georgetown University. The Project Coordinators were responsible for supervising both the Research Assistants and the work study students. TARGET AUDIENCES: During recruitment, we aimed to have participants with a variety of different backgrounds. Participants were recruited from the DC Metropolitan area, daycare centers or schools, within the Capital Area Primary Care Research Network (CAPRICORN), and the Georgetown University clinical trial website. We have recruited participants from different social, economical, and educational backgrounds and have participants that are both Spanish and English speakers. PROJECT MODIFICATIONS: Not relevant to this project.
Impacts
At 60 per cent recruitment the preliminary outcomes have been the following: All researchers, the Principal Investigator, statisticians and the participants are still blinded. More parents in Group B have reported adverse events that they thought were possibly associated with the drink; however there have been more reports of diarrhea in Group A. Currently all demographics in both groups are equal, with one exception; Group A reported more mothers who breastfed, 94 per cent versus 80 per cent. Both groups are experiencing less illness and missed school than historical cohorts have reported. The last cohort is currently enrolled and we should start examining unblended data by early winter.
Publications
- No publications reported this period
|
|