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

• ClinicalTrials.gov Identifier: NCT02508844
• Recruitment Status: Completed
• First Posted: July 27, 2015
• Last Update Posted: March 23, 2020
• Sponsor: Hvidovre University Hospital
• Collaborators: University of Copenhagen; Statens Serum Institut
• Information provided by (Responsible Party): Andreas Munk Petersen, Hvidovre University Hospital

Study Description

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual 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
• Actual Primary Completion Date: January 2018
• Actual Study Completion Date: March 2020

Arms and Interventions

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.

Outcome Measures

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 ]

Eligibility Criteria

• 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

Contacts and Locations

Locations

Denmark

Hvidovre University Hospital

Hvidovre, Copenhagen, Denmark, 2650

Sponsors and Collaborators

Hvidovre University Hospital

University of Copenhagen

Statens Serum Institut

Investigators

• Principal Investigator: Andreas M Petersen, MD, PhD; Hvidovre University Hospital

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

• Responsible Party: Andreas Munk Petersen, MD, clinical associate professor, Ph.D., Hvidovre University Hospital
• ClinicalTrials.gov Identifier: NCT02508844
• Other Study ID Numbers: H-2-2014-076
• First Posted: July 27, 2015
• Last Update Posted: March 23, 2020
• Last Verified: March 2020

Keywords provided by Andreas Munk Petersen, Hvidovre University Hospital:

Probiotics; Vivomixx®; Microbiota

Additional relevant MeSH terms:

Diabetes, Gestational; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases