Modulation of the Intestinal Flora With the Probiotic VIVOMIXX™ in Pregnant Women at Risk of Metabolic Complications

NCT02768818 | Unknown Phase 3

• 1 other identifier: CE 91/14
• Study Type: interventional
• Target: 205
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators aimed at evaluating the effectiveness of probiotics ingestion in changing maternal microbiota and preventing gestational diabetes in overweight and obese women. To achieve these goals, obese (BMI\> 30 kg/m\^2) or overweight (BMI\> 25 kg/m\^2) pregnant women with risk factors were enrolled in the study and randomized to the supplementation with the probiotic VIVOMIXX® or with placebo. The endpoints of this study are to evaluate if the dietary supplementation with the probiotic VIVOMIXX® modifies the maternal fecal microbiota (bifidobacteria and lactobacilli) and related enzymatic activity (alkaline sphingomyelinase and alkaline phosphatase), and if this if this is linked to an improvement of the intermediate metabolism (positive Oral Glucose Tolerance Test at 24-26 weeks).

Conditions

Gestational Diabetes Mellitus in Pregnancy, Diet- Controlled; Exercise Addiction; High-Risk Pregnancy; Dietary Modification

Keywords

Maternal Obesity Complicating Pregnancy

Outcome Measures

Primary Outcomes (2)

• Maternal and newborn fecal microbiota changes (bifidobacteria and lactobacilli) and related enzymatic activity (alkaline sphingomyelinase and alkaline phosphatase) modifications

  NMR-based metabolomics, microbiota and high performance liquid chromatography-mass spectrometry -HPLC/MS- of vitamins analysis

  At baseline, at 24-26 week, at 36-38 week, 2-3 days after delivery

• Glucose metabolism changes

  Positive Oral Glucose Tolerance Test

  At 24-26 week

Secondary Outcomes (27)

• Weight changes

  At baseline, at 24-26 week, at 36-38 week, 2-3 days after delivery

• Maternal BMI

  At baseline, at 24-26 week, at 36-38 week, 2-3 days after delivery

• Waist/hip circumference ratio

  At baseline, at 24-26 week, at 36-38 week, 2-3 days after delivery

• Gestational weight gain

  At baseline, at 24-26 week, at 36-38 week, 2-3 days after delivery

• HOMA Index

  At baseline, at 24-26 week, at 36-38 week, 2-3 days after delivery

Study Arms (2)

Intervention

EXPERIMENTAL

Probiotic VIVOMIXX™

Dietary Supplement: Probiotic VIVOMIXX™

Control

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo

Interventions

Probiotic VIVOMIXX™ DIETARY_SUPPLEMENT

The patients will be randomly assigned to the VIVOMIXX™ (intervention) or the control (placebo) group through a randomization list elaborated by a specific software.

Intervention

Placebo DIETARY_SUPPLEMENT

The patients will be randomly assigned to the VIVOMIXX™ (intervention) or the control (placebo) group through a randomization list elaborated by a specific software.

Control

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women aged between 20 and 40 with singleton pregnancies and BMI at recruitment \> 30 kg/m\^2 or a BMI\> 25 kg/m\^2 and the simultaneous presence of at least 1 of the following risk factors: age\> 35 years, previous fetal macrosomia (\> 4500gr), family history of diabetes (first-degree relative with type 2 diabetes mellitus), previous gestational diabetes mellitus.
• Adherence to lifestyle prescription including dietary counselling and physical activity stimulation

You may not qualify if:

• Subjects who require intervention in addition to the lifestyle changes women with diet and habits much different from the Mediterranean area (Central Africa, Asian, etc..). In such subgroup it will be difficult to obtain adherence to diet prescription since their cultural attitudes and dietary habits.
• Pre-pregnancy BMI\> 40 kg/m\^2
• Chronic hypertension
• Fasting glycemia in the first trimester of\> 126 mg / dl or random glycemia \> 200 mg/dl

Sponsors & Collaborators

• University of Modena and Reggio Emilia: lead

Study Sites (1)

Mother-Infant Department, University of Modena and Reggio Emilia, Italy

Modena, 41124, Italy

RECRUITING

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman of Obstetrics and Gynecology Unit

Study Record Dates

• First Submitted: April 20, 2016
• First Posted: May 11, 2016
• Study Start: January 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: December 1, 2016
• Last Updated: May 11, 2016

Record last verified: 2016-01

Locations

IT (1)