Clinical trial NCT02508844: Effect of Probiotics (Vivomixx®) on Weight, Microbiota and Glucose Tolerance in Obese Pregnant Women and Their Newborn
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pregnancy
Obesity
Gestational Diabetes Mellitus
Keywords: Probiotics
Vivomixx®
Microbiota
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
name: Statens Serum Institut
First posted: 2015-07-27
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to investigate if the probiotics Vivomixx® can affect gestational weight gain, microbiota and pregnancy complications in pregnant obese women and birth weight body composition of their infants.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* BMI ≥ 30 and ≤35 kg/m2- calculated from pre-pregnancy weight
* Primiparous singleton pregnancy
* Able to read and speak Danish
* Normal ultrasound scan of the fetus at gestational age 12-14
* Oral glucose tolerance test at gestational age 14-20

Exclusion Criteria:

* Pregnancy at \> 20 weeks gestation at recruitment
* Pre-gestational diabetes or other serious diseases
* Multiple pregnancy
* Previous bariatric surgery
* Ingestion of probiotics \< 1 month before the inclusion or ingestion of other kinds of probiotics than the study probiotics

Primary outcomes:
measure: Gestational weight gain
timeFrame: week 36-37 of pregnancy
measure: Change in glucose levels (Oral glucose tolerance test)
timeFrame: baseline (week 14-20) and 27-30 of pregnancy
Secondary outcomes:
measure: Change in fecal microbiota
timeFrame: baseline (week 14-20) and week 36-37 of pregnancy
measure: Amount of fat tissue in the newborn infant
timeFrame: at birth
measure: Change in HbA1c
timeFrame: baseline (week 14-20) and week 36-37 of pregnancy
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre University Hospital
state: Copenhagen
Study officials:
affiliation: Hvidovre University Hospital
name: Andreas M Petersen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Halkjaer SI, de Knegt VE, Lo B, Nilas L, Cortes D, Pedersen AE, Mirsepasi-Lauridsen HC, Andersen LO, Nielsen HV, Stensvold CR, Johannesen TB, Kallemose T, Krogfelt KA, Petersen AM. Multistrain Probiotic Increases the Gut Microbiota Diversity in Obese Pregnant Women: Results from a Randomized, Double-Blind Placebo-Controlled Study. Curr Dev Nutr. 2020 May 27;4(7):nzaa095. doi: 10.1093/cdn/nzaa095. eCollection 2020 Jul.
citation: Halkjaer SI, Nilas L, Carlsen EM, Cortes D, Halldorsson TI, Olsen SF, Pedersen AE, Krogfelt KA, Petersen AM. Effects of probiotics (Vivomixx(R)) in obese pregnant women and their newborn: study protocol for a randomized controlled trial. Trials. 2016 Oct 11;17(1):491. doi: 10.1186/s13063-016-1617-5.