Effect of Probiotics (Vivomixx®) on Weight, Microbiota and Glucose Tolerance in Obese Pregnant Women and Their Newborn (POP)
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|ClinicalTrials.gov Identifier: NCT02508844|
Recruitment Status : Unknown
Verified August 2016 by Andreas Munk Petersen, Hvidovre University Hospital.
Recruitment status was: Recruiting
First Posted : July 27, 2015
Last Update Posted : August 15, 2016
|Condition or disease||Intervention/treatment||Phase|
|Pregnancy Obesity Gestational Diabetes Mellitus||Dietary Supplement: Vivomixx® Dietary Supplement: Placebo||Phase 4|
Accumulating evidence indicates that the gut microbiota plays a significant role in obesity and because the "ideal" composition of the gut microbiota remains poorly understood, modulation of the gut microbiota composition represents a potentially attractive treatment option against excessive gestational weight gain and adverse outcomes for obese pregnant women and their newborn. Dietary supplements in the form of probiotics could be an efficient treatment for controlling weight gain in pregnancy by inducing changes in the gut microbiota and could have influence on infant's microbiota, which could have important implications for infant development and health.
A pilot study including 50 obese pregnant nulliparous with BMI between 30-35 kg/m2 will, after accepting participation, be randomized to receive daily placebo or probiotics (four capsules of Vivomixx®; total of 450 billion CFU/day) from gestational age 14-20 until delivery. The infants will be followed until 9 months of age. Shortly after birth, tissue composition will be measured in the infants by DEXA-scanning. The women will be monitored by weight, blood-, fecal- and urine samples, diet questionnaires and hospital record review. Vivomixx® is a probiotic mixture of 8 probiotic strains, (Bifidobacterium breve, Bifidobacterium longum, Bifidobacterium infantis, Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus paracasei, Lactobacillus bulgaricus and Streptococcus thermophilus).
This is the first pilot study in which the probiotic Vivomixx® are added in a randomized fashion to the standard of care in obese pregnant women. 50 pregnant women are planned to be included. The aim of this group size is to clarify the feasibility, compliance and to estimate parameters such as the standard deviation which will be used in a sample size calculation for a full-scale trial.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The POP-study: Effect of Probiotics on Weight, Microbiota and Glucose Tolerance in Obese Pregnant Women and Their Newborn - a Randomized, Double-blind Placebo Controlled Trial With Vivomixx®|
|Study Start Date :||April 2015|
|Estimated Primary Completion Date :||April 2017|
|Estimated Study Completion Date :||October 2017|
Bifidobacterium breve, Bifidobacterium longum, Bifidobacterium infantis, Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus paracasei, Lactobacillus bulgaricus and Streptococcus thermophilus
Dietary Supplement: Vivomixx®
probiotics intake (four capsules of Vivomixx®; total of 450 billion CFU/day) from gestational age 14-20 until delivery
Placebo Comparator: Placebo
microcrytalline cellulose, magnesium stearate and silicon dioxide.
Dietary Supplement: Placebo
Four capsules/day from gestational age 14-20 until delivery. The placebo capsule contains microcrytalline cellulose, magnesium stearate and silicon dioxide.
- Gestational weight gain [ Time Frame: week 36-37 of pregnancy ]weight at gestational age 36-37-weeks minus self-reported pre-pregnancy weight
- Change in glucose levels (Oral glucose tolerance test) [ Time Frame: baseline (week 14-20) and 27-30 of pregnancy ]
- Change in fecal microbiota [ Time Frame: baseline (week 14-20) and week 36-37 of pregnancy ]
- Amount of fat tissue in the newborn infant [ Time Frame: at birth ]examined by a DEXA-scanning
- Change in HbA1c [ Time Frame: baseline (week 14-20) and week 36-37 of pregnancy ]
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): NCT02508844
|Contact: Andreas M Petersen, MD, PhDemail@example.com|
|Contact: Sofie I Halkjær, Mscfirstname.lastname@example.org|
|Principal Investigator:||Andreas M Petersen, MD, PhD||Hvidovre University Hospital|