Effect of Probiotics (Vivomixx®) on Weight, Microbiota and Glucose Tolerance in Obese Pregnant Women and Their Newborn

Obesity Clinical Trial

— POP  

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®

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02508844
• Other study ID #: H-2-2014-076
• Status: Completed
• Phase: Phase 4
• Start date: April 2015
• Est. completion date: March 2020

Study information

• Verified date: March 2020
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2020
• Est. primary completion date: January 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes, Gestational
• Gestational Diabetes Mellitus
• Obesity
• Pregnancy

Intervention

Dietary Supplement:
• Vivomixx®
probiotics intake (four capsules of Vivomixx®; total of 450 billion CFU/day) from gestational age 14-20 until delivery
• Placebo
Four capsules/day from gestational age 14-20 until delivery. The placebo capsule contains microcrytalline cellulose, magnesium stearate and silicon dioxide.

Locations

Country	Name	City	State
Denmark	Hvidovre University Hospital	Hvidovre	Copenhagen

Sponsors (3)

Lead Sponsor	Collaborator
Hvidovre University Hospital	Statens Serum Institut, University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gestational weight gain	weight at gestational age 36-37-weeks minus self-reported pre-pregnancy weight	week 36-37 of pregnancy
Primary	Change in glucose levels (Oral glucose tolerance test)		baseline (week 14-20) and 27-30 of pregnancy
Secondary	Change in fecal microbiota		baseline (week 14-20) and week 36-37 of pregnancy
Secondary	Amount of fat tissue in the newborn infant	examined by a DEXA-scanning	at birth
Secondary	Change in HbA1c		baseline (week 14-20) and week 36-37 of pregnancy