Prenatal Probiotic Intervention
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|ClinicalTrials.gov Identifier: NCT03240419|
Recruitment Status : Recruiting
First Posted : August 7, 2017
Last Update Posted : September 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Childhood Obesity Maternal Obesity During Childbirth Insulin Resistance Inflammation||Dietary Supplement: Probiotics Dietary Supplement: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Probiotic Supplementation in Obese Pregnant Women. A Feasibility Study.|
|Actual Study Start Date :||August 23, 2017|
|Estimated Primary Completion Date :||August 2018|
|Estimated Study Completion Date :||December 2018|
Each probiotic capsule contains 180 mg of a standardized white to light beige fine powder consisting of freeze-dried cultures. Specifically, Bifidobacterium BB-12® and Lactobacillus rhamnosus LGG® (50%:50%). This product has a minimum potency of 6.5 billion (6.5E+9) CFU (ColonyForming Units) per capsule. Other ingredients in the powder are: microcrystalline cellulose, maltodextrin, silicon dioxide and magnesium stearate. Participants in this group will take one daily capsule orally starting at the time of recruitment (gestation week 12) and until delivery.
Dietary Supplement: Probiotics
Bifidobacterium BB12 and Lactobacillus Rhamosus LGG (50%:50%) capsules.
Other Name: live cultures
Placebo Comparator: Placebo
Participants in this group will take one capsule containing microcrystalline cellulose, maltodextrin, silicon dioxide and magnesium stearate (all ingredients listed in the probiotic capsules except the culture) . Participants in this group will take one daily capsule orally starting at the time of recruitment (gestation week 12) and until delivery.
Dietary Supplement: Placebo
capsule manufactured to mimic probiotic capsules.
- Change in acceptance of probiotic supplementation throughout pregnancy in obese women. [ Time Frame: Self-administered questionnaires will be done at gestation weeks 12,14, 18, 22, 26, 30 and 36 ]Participants will answer acceptability questionnaires in which they will have to rate (1= poor, 2= fair, 3= good, 4= very good, and 5= excellent ) their experience with capsule supplementation and study procedures.
- Change in compliance with probiotic supplementation throughout pregnancy in obese women. [ Time Frame: Pill count will be done at gestation weeks 12,14, 18, 22, 26, 30 and 36 ]Change in compliance with capsule supplementation will be assessed during pregnancy via pill-count.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03240419
|Contact: Eva C Diaz Fuentes, MDfirstname.lastname@example.org|
|Contact: Aline Andres, PhD||501-364-3301||AndresAline@uams.edu|
|United States, Arkansas|
|Arkansas Children's Nutrition Center||Recruiting|
|Little Rock, Arkansas, United States, 72202|
|Contact: Eva C Diaz Fuentes, MD 501-364-3056 email@example.com|
|Contact: Aline Andres, MD 501-364-3301 AndresAline@uams.edu|
|Principal Investigator:||Eva C Diaz Fuentes, MD||University of Arkansas|