Ignite Creation Date:
2024-05-06 @ 3:15 AM
Last Modification Date:
2024-10-26 @ 11:31 AM
Study NCT ID:
NCT02249325
Status:
COMPLETED
Last Update Posted:
2014-10-07
First Post:
2013-06-03
Brief Title:
Quasi Experiment of Prenatal Probiotics Against Group B Streptococcus Colonization
Sponsor:
Marquette University
Organization:
Marquette University
Study Overview
Official Title:
Effects of Probiotic Use During Pregnancy on Lactobacillus and Group B Streptococcus Vaginal Colonization A Pilot Study
Status:
COMPLETED
Status Verified Date:
2014-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This pilot quasi experiment was designed to determine the feasibility of a randomized controlled trial of the oral probiotic combination of Florajen3 75 x109 L acidophilus 60 x109 B lactis and 15 x109 B longum taken orally once daily beginning at 28 weeks gestation against placebo to reduce the colonization of group B Streptococcus at 36 weeks
Detailed Description:
Methods
A non-blinded open-label quasi-experimental design was approved by the Institutional Review Boards of three institutions two universities and the clinical research site The study setting was a large Certified Nurse-Midwife subsequently referred to as midwife clinical practice serving a culturally and economically diverse urban population in the Midwest region of the USA
Participants Women self-selected to participate in screening and informed consent procedures done by the first two authors The following inclusion criteria were used at study enrollment low risk no obstetric fetal medical or genetic risk factors adult 18 years of age pregnant at 28 2 weeks gestation able to speak and write English and expressing willingness to participate in the study intervention oral probiotic and data collection vaginal and rectal swabs questionnaires
A convenience sample of 20 healthy pregnant participants was sought Following informed consent the first 10 subjects were assigned to the experimental group Nonrandom assignment was used to assure that the 10 experimental group participants were enrolled while remaining within funding and time constraints After enrolling the experimental group the next ten women were assigned to the control group
Intervention
The study intervention consisted of one capsule of Florajen3 previously described orally each day Florajen3 meets the internationally established probiotic criteria FAOWHO 2001 The probiotics contained in Florajen3 are non-spore-forming lactose- and hydrogen-peroxide-producing bacteria The manufacturer recommends refrigeration to maintain maximum potency As part of the preparation for this study a sample of Florajen3 was left unrefrigerated for a period of 6 weeks and appropriate colony counts were sustained Therefore for the purpose of the study the participants in the experimental group were allowed to leave the probiotic unrefrigerated in an effort to improve daily compliance Experimental group study participants were made aware of the probiotic brand used open label as the intervention
Further the current state of knowledge about prenatal probiotics including potentially rare side effects were discussed at length using a 10-page informed consent document The Florajen3 was placed in a study bottle equipped with an electronic cap monitoring system MEMS AARDEX designed to record each time the bottle was opened by the participant Each opening of the cap bottle equipped with this system is recorded on a microchip The number of openings are retrievable via computer software when the bottle caps are returned Researchers midwives and participants were aware of group assignment The control group participants did not receive a placebo
Procedures
Midwife prenatal care providers and staff were oriented to the study data collection procedures Study data were collected at three points during routine prenatal visits with each participants midwife 282 weeks 322 weeks and 362 weeks gestation The study was considered completed at the 362 weeks gestation visit All participants received compensation at the completion of 2 study visits 25 USD at 322 weeks and 75 USD at 362 weeks gestation Probiotic group participants were offered a supply of probiotics for the remainder of pregnancy
The midwife prenatal provider collected demographic information birth date race and gestational age and the vaginal and rectal swabs for GBS and wet mount using accepted criteria to identify the vaginal pH and the presence of normal flora andor pathogens The wet mounts were examined microscopically by each midwife using standardized wet mount diagnostic procedures with normal saline and potassium hydroxide and documented in a standard format Participants completed a brief questionnaire at each study visit that asked them to describe yogurt ingestion sexual activity frequency and type and vaginal cleansing practices if used in the past week these were considered potential confounding variables The participants were also asked if these practices were typical for them and if not how they were atypical Women in the experimental group were asked to report any side effects that they attributed to the probiotics by notifying their midwife immediately if necessary and then also noting the information on the study questionnaire As part of routine prenatal care the CDC-required GBS vaginal to rectal swab was collected by each participants midwife and sent to the hospital laboratory between the 35 and 37 week visit This was the only result that determined the need for IAP
Researchers oversaw data collection and sample packaging Participants were asked to return their probiotic bottles at each study visit and the Florajen3 capsules were replaced with a fresh supply This gave the researchers the opportunity to notify the laboratory to record the date for later evaluation of the electronic cap monitoring results and conduct pill counts as an additional means to monitor womens responses to study participation as well as probiotic adherence at each study visit The vaginal and rectal swabs were placed on ice packaged according to accepted procedures for human specimen handling and shipped overnight to the laboratory of the final author located 80 miles from the study site for processing and analysis
Laboratory Analysis Upon receipt at the laboratory the vaginal and rectal swabs were processed for quantitative colony counts of GBS Polymerase chain reaction PCR was performed to determine whether bacteria isolated were the same as those in Florajen3 If positive for PCR pulsed field gel electrophoresis PFGE would be performed to confirm the strain identity
These results were for research purposes only and were not available to the practicing midwives
The routine CDC-recommended prenatal GBS vaginal to rectal swabs were analyzed at the hospital laboratory using a culture based method in which a threshold for GBS positive results is considered greater than 102 colony forming units CFU per swab These results determined the need for IAP and were available to the midwives for management during labor
Statistical Analysis
Demographics the study variables and laboratory data were entered into and analyzed with a statistical software package Descriptive statistics Confidence Intervals Chi-squares T-tests and correlations were used for analysis Data were compared between subjects at each study visit and between groups at each data collection point The qualitative prenatal GBS culture results positive or negative from the hospital laboratory were compared to the quantitative vaginal and rectal GBS study results adherence data and confounding variables yogurt ingestion sexual activity and vaginal cleansing practices
A non-blinded open-label quasi-experimental design was approved by the Institutional Review Boards of three institutions two universities and the clinical research site The study setting was a large Certified Nurse-Midwife subsequently referred to as midwife clinical practice serving a culturally and economically diverse urban population in the Midwest region of the USA
Participants Women self-selected to participate in screening and informed consent procedures done by the first two authors The following inclusion criteria were used at study enrollment low risk no obstetric fetal medical or genetic risk factors adult 18 years of age pregnant at 28 2 weeks gestation able to speak and write English and expressing willingness to participate in the study intervention oral probiotic and data collection vaginal and rectal swabs questionnaires
A convenience sample of 20 healthy pregnant participants was sought Following informed consent the first 10 subjects were assigned to the experimental group Nonrandom assignment was used to assure that the 10 experimental group participants were enrolled while remaining within funding and time constraints After enrolling the experimental group the next ten women were assigned to the control group
Intervention
The study intervention consisted of one capsule of Florajen3 previously described orally each day Florajen3 meets the internationally established probiotic criteria FAOWHO 2001 The probiotics contained in Florajen3 are non-spore-forming lactose- and hydrogen-peroxide-producing bacteria The manufacturer recommends refrigeration to maintain maximum potency As part of the preparation for this study a sample of Florajen3 was left unrefrigerated for a period of 6 weeks and appropriate colony counts were sustained Therefore for the purpose of the study the participants in the experimental group were allowed to leave the probiotic unrefrigerated in an effort to improve daily compliance Experimental group study participants were made aware of the probiotic brand used open label as the intervention
Further the current state of knowledge about prenatal probiotics including potentially rare side effects were discussed at length using a 10-page informed consent document The Florajen3 was placed in a study bottle equipped with an electronic cap monitoring system MEMS AARDEX designed to record each time the bottle was opened by the participant Each opening of the cap bottle equipped with this system is recorded on a microchip The number of openings are retrievable via computer software when the bottle caps are returned Researchers midwives and participants were aware of group assignment The control group participants did not receive a placebo
Procedures
Midwife prenatal care providers and staff were oriented to the study data collection procedures Study data were collected at three points during routine prenatal visits with each participants midwife 282 weeks 322 weeks and 362 weeks gestation The study was considered completed at the 362 weeks gestation visit All participants received compensation at the completion of 2 study visits 25 USD at 322 weeks and 75 USD at 362 weeks gestation Probiotic group participants were offered a supply of probiotics for the remainder of pregnancy
The midwife prenatal provider collected demographic information birth date race and gestational age and the vaginal and rectal swabs for GBS and wet mount using accepted criteria to identify the vaginal pH and the presence of normal flora andor pathogens The wet mounts were examined microscopically by each midwife using standardized wet mount diagnostic procedures with normal saline and potassium hydroxide and documented in a standard format Participants completed a brief questionnaire at each study visit that asked them to describe yogurt ingestion sexual activity frequency and type and vaginal cleansing practices if used in the past week these were considered potential confounding variables The participants were also asked if these practices were typical for them and if not how they were atypical Women in the experimental group were asked to report any side effects that they attributed to the probiotics by notifying their midwife immediately if necessary and then also noting the information on the study questionnaire As part of routine prenatal care the CDC-required GBS vaginal to rectal swab was collected by each participants midwife and sent to the hospital laboratory between the 35 and 37 week visit This was the only result that determined the need for IAP
Researchers oversaw data collection and sample packaging Participants were asked to return their probiotic bottles at each study visit and the Florajen3 capsules were replaced with a fresh supply This gave the researchers the opportunity to notify the laboratory to record the date for later evaluation of the electronic cap monitoring results and conduct pill counts as an additional means to monitor womens responses to study participation as well as probiotic adherence at each study visit The vaginal and rectal swabs were placed on ice packaged according to accepted procedures for human specimen handling and shipped overnight to the laboratory of the final author located 80 miles from the study site for processing and analysis
Laboratory Analysis Upon receipt at the laboratory the vaginal and rectal swabs were processed for quantitative colony counts of GBS Polymerase chain reaction PCR was performed to determine whether bacteria isolated were the same as those in Florajen3 If positive for PCR pulsed field gel electrophoresis PFGE would be performed to confirm the strain identity
These results were for research purposes only and were not available to the practicing midwives
The routine CDC-recommended prenatal GBS vaginal to rectal swabs were analyzed at the hospital laboratory using a culture based method in which a threshold for GBS positive results is considered greater than 102 colony forming units CFU per swab These results determined the need for IAP and were available to the midwives for management during labor
Statistical Analysis
Demographics the study variables and laboratory data were entered into and analyzed with a statistical software package Descriptive statistics Confidence Intervals Chi-squares T-tests and correlations were used for analysis Data were compared between subjects at each study visit and between groups at each data collection point The qualitative prenatal GBS culture results positive or negative from the hospital laboratory were compared to the quantitative vaginal and rectal GBS study results adherence data and confounding variables yogurt ingestion sexual activity and vaginal cleansing practices
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None