Obesity Clinical Trial - Effect of Probiotics (Vivomixx®) on Weight,

Status Completed

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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02508844
Study type	Interventional
Source	Hvidovre University Hospital
Contact
Status	Completed
Phase	Phase 4
Start date	April 2015
Completion date	March 2020

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04101669` - EndoBarrier System Pivotal Trial(Rev E v2)	N/A
Recruiting	`NCT04243317` - Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults	N/A
Terminated	`NCT03772886` - Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball	N/A
Completed	`NCT03640442` - Modified Ramped Position for Intubation of Obese Females.	N/A
Completed	`NCT04506996` - Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2	N/A
Recruiting	`NCT06019832` - Analysis of Stem and Non-Stem Tibial Component	N/A
Active, not recruiting	`NCT05891834` - Study of INV-202 in Patients With Obesity and Metabolic Syndrome	Phase 2
Active, not recruiting	`NCT05275959` - Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI)	N/A
Recruiting	`NCT04575194` - Study of the Cardiometabolic Effects of Obesity Pharmacotherapy	Phase 4
Completed	`NCT04513769` - Nutritious Eating With Soul at Rare Variety Cafe	N/A
Withdrawn	`NCT03042897` - Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer	N/A
Completed	`NCT03644524` - Heat Therapy and Cardiometabolic Health in Obese Women	N/A
Recruiting	`NCT05917873` - Metabolic Effects of Four-week Lactate-ketone Ester Supplementation	N/A
Active, not recruiting	`NCT04353258` - Research Intervention to Support Healthy Eating and Exercise	N/A
Completed	`NCT04507867` - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III	N/A
Recruiting	`NCT03227575` - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control	N/A
Completed	`NCT01870947` - Assisted Exercise in Obese Endometrial Cancer Patients	N/A
Recruiting	`NCT06007404` - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Recruiting	`NCT05972564` - The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function	Phase 1/Phase 2
Recruiting	`NCT05371496` - Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms