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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02508844
Other study ID # H-2-2014-076
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


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
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