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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
Sponsor:
Collaborators:
University of Copenhagen
Statens Serum Institut
Information provided by (Responsible Party):
Andreas Munk Petersen, Hvidovre University Hospital

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.

Condition or disease Intervention/treatment Phase
Pregnancy Obesity Gestational Diabetes Mellitus Dietary Supplement: Vivomixx® Dietary Supplement: Placebo Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
Experimental: Vivomixx®
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.




Primary Outcome Measures :
  1. Gestational weight gain [ Time Frame: week 36-37 of pregnancy ]
    weight at gestational age 36-37-weeks minus self-reported pre-pregnancy weight

  2. Change in glucose levels (Oral glucose tolerance test) [ Time Frame: baseline (week 14-20) and 27-30 of pregnancy ]

Secondary Outcome Measures :
  1. Change in fecal microbiota [ Time Frame: baseline (week 14-20) and week 36-37 of pregnancy ]
  2. Amount of fat tissue in the newborn infant [ Time Frame: at birth ]
    examined by a DEXA-scanning

  3. Change in HbA1c [ Time Frame: baseline (week 14-20) and week 36-37 of pregnancy ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Contacts
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Contact: Andreas M Petersen, MD, PhD andreas.munk.petersen@regionh.dk
Contact: Sofie I Halkjær, Msc sofiehalkjaer@gmail.com

Locations
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Denmark
Hvidovre University Hospital Recruiting
Hvidovre, Copenhagen, Denmark, 2650
Contact: Andreas M Petersen, MD, PhD       andreas.munk.petersen@regionh.dk   
Contact: Sofie I Halkjær, Msc       sofiehalkjaer@gmail.com   
Sponsors and Collaborators
Hvidovre University Hospital
University of Copenhagen
Statens Serum Institut
Investigators
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Principal Investigator: Andreas M Petersen, MD, PhD Hvidovre University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Andreas Munk Petersen, MD, clinical associate professor, Ph.D., Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT02508844     History of Changes
Other Study ID Numbers: H-2-2014-076
First Posted: July 27, 2015    Key Record Dates
Last Update Posted: August 15, 2016
Last Verified: August 2016
Keywords provided by Andreas Munk Petersen, Hvidovre University Hospital:
Probiotics
Vivomixx®
Microbiota
Additional relevant MeSH terms:
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Diabetes, Gestational
Pregnancy Complications
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases