search
Back to results

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

Primary Purpose

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

Status
Unknown status
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Probiotic VIVOMIXX™
Placebo
Sponsored by
University of Modena and Reggio Emilia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gestational Diabetes Mellitus in Pregnancy, Diet- Controlled focused on measuring Maternal Obesity Complicating Pregnancy

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Mother-Infant Department, University of Modena and Reggio Emilia, ItalyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention

Control

Arm Description

Probiotic VIVOMIXX™

Placebo

Outcomes

Primary Outcome Measures

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
Glucose metabolism changes
Positive Oral Glucose Tolerance Test

Secondary Outcome Measures

Weight changes
Measured in kg
Maternal BMI
Measured in kg/m^2
Waist/hip circumference ratio
Gestational weight gain
Measured in kg
HOMA Index
HbA1c1
glycemia
insulinemia
homocysteine plasmatic levels
Requirement for insulin therapy
Week of onset
Requirement for insulin therapy
Dose of insulin
Quality of sleep
Hours of deep sleep measured through the armband
Duration of sleep
Measured in hours through the armband
Onset of hypertension / preeclampsia
Time of delivery
Mode of delivery
Complications during delivery
Surgery and/or hemorrhage >500ml and/or shoulder dystocia
Apgar score
Newborn's weight
Newborn's sex
Newborn's abdomen / head ratio
Newborn's skinfold thickness at birth
Neonatal hypoglycemia
Neonatal hypoglycemia (measured in mg/dl) that requires therapy
Neonatal bilirubinemia
Measured in mg/dl
Neonatal complications
Respiratory Distress Syndrome, Necrotizing Enterocolitis, Retinopathy of prematurity, Bronchopulmonary Dysplasia, Neonatal Death
Admission to Neonatal Intensive Care Unit (NICU)
Admission to NICU
Admission to Neonatal Intensive Care Unit (NICU)
Duration of stay at the NICU

Full Information

First Posted
April 20, 2016
Last Updated
May 9, 2016
Sponsor
University of Modena and Reggio Emilia
search

1. Study Identification

Unique Protocol Identification Number
NCT02768818
Brief Title
Modulation of the Intestinal Flora With the Probiotic VIVOMIXX™ in Pregnant Women at Risk of Metabolic Complications
Official Title
Modulation of the Intestinal Flora With the Probiotic VIVOMIXX™ in Pregnant Women at Risk of Metabolic Complications
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
December 2016 (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Modena and Reggio Emilia

4. Oversight

5. Study Description

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).
Detailed Description
This is a prospective, multicenter, randomized, double-blind, placebo-controlled trial. 208 pregnant women from the recruiting centers will be enrolled as follow: Women eligible to participate, prior informed consent, will be randomized to 2 capsules twice daily before breakfast and before dinner from randomization until delivery. The boxes will be given to the patients coded and blinded to investigators and participants, and will contain either the active ingredient (VIVOMIXX®, a mixture of 112 billion of eight strains for each capsule, namely Streptococcus thermophilus, bifidobacteria (B. breve, B. longum, B. infantis) and lactobacilli (L. paracasei, L. acidophilus, L. delbrueckii subsp bulgaricus, L. plantarum) or placebo. The protocol includes a screening visit (Visit 1) at 10-12 weeks, two visits during pregnancy (at 26-28 weeks= Visit 2, and at 36-38 weeks=Visit 3) and a postnatal visit (2-3 days after delivery=Visit 4). Eligible women should take two capsules twice daily (2 in the morning and 2 in the evening). Patients will be randomly assigned to the control or the VIVOMIXX® group. The study agent VIVOMIXX® as well as the placebo will be supplied by "Mendes SA" for the whole study period. During Visit 1 (at 10-12 weeks) written consent will be obtained, after information on expected benefits and possible inconveniences related to participation in the trial. Furthermore, eligible women will be asked to complete two questionnaires, one on dietary habits and one on gastrointestinal symptoms. The questionnaire on gastrointestinal symptoms will be submitted to the patients at each visit. Height will be assessed at Visit 1, while the following parameters will be measured at each visit: weight, waits/hip circumference ratio, arterial blood pressure, plasma hemoglobin (Hb), hematocrit (Ht), fasting glycemia, fasting insulin and fasting glycated hemoglobin (HbA1c1). A blood sample for the evaluation of homocysteine will be taken as well as urine and a faeces sample will be collected for nuclear-magnetic-resonance (NMR)-based metabolomics and intestinal microbiota analysis. Furthermore, an Arm-band will be positioned for monitoring sleep and physical activities for one week at each visit. At Visit 2 and 3 data regarding ultrasound examinations (Amniotic fluid index, abdominal circumference, cephalic circumference ratio) will be also collected. Two-three days after delivery (Visit 4) data regarding the delivery (mode of delivery, gestational age at delivery) as well as the newborn (Apgar score, glycemia and serum bilirubin) were collected. Moreover, a sample of colostrum (for NMR-based metabolomics, microbiota and high performance liquid chromatography-mass spectrometry -HPLC/MS- of vitamins analysis) and newborn faeces (for NMR-based metabolomics and microbiota analysis) sample will be collected.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes Mellitus in Pregnancy, Diet- Controlled, Exercise Addiction, High-Risk Pregnancy, Dietary Modification
Keywords
Maternal Obesity Complicating Pregnancy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
205 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Probiotic VIVOMIXX™
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic VIVOMIXX™
Intervention Description
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 Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
The patients will be randomly assigned to the VIVOMIXX™ (intervention) or the control (placebo) group through a randomization list elaborated by a specific software.
Primary Outcome Measure Information:
Title
Maternal and newborn fecal microbiota changes (bifidobacteria and lactobacilli) and related enzymatic activity (alkaline sphingomyelinase and alkaline phosphatase) modifications
Description
NMR-based metabolomics, microbiota and high performance liquid chromatography-mass spectrometry -HPLC/MS- of vitamins analysis
Time Frame
At baseline, at 24-26 week, at 36-38 week, 2-3 days after delivery
Title
Glucose metabolism changes
Description
Positive Oral Glucose Tolerance Test
Time Frame
At 24-26 week
Secondary Outcome Measure Information:
Title
Weight changes
Description
Measured in kg
Time Frame
At baseline, at 24-26 week, at 36-38 week, 2-3 days after delivery
Title
Maternal BMI
Description
Measured in kg/m^2
Time Frame
At baseline, at 24-26 week, at 36-38 week, 2-3 days after delivery
Title
Waist/hip circumference ratio
Time Frame
At baseline, at 24-26 week, at 36-38 week, 2-3 days after delivery
Title
Gestational weight gain
Description
Measured in kg
Time Frame
At baseline, at 24-26 week, at 36-38 week, 2-3 days after delivery
Title
HOMA Index
Time Frame
At baseline, at 24-26 week, at 36-38 week, 2-3 days after delivery
Title
HbA1c1
Time Frame
At baseline, at 24-26 week, at 36-38 week, 2-3 days after delivery
Title
glycemia
Time Frame
At baseline, at 24-26 week, at 36-38 week, 2-3 days after delivery
Title
insulinemia
Time Frame
At baseline, at 24-26 week, at 36-38 week, 2-3 days after delivery
Title
homocysteine plasmatic levels
Time Frame
At baseline, at 24-26 week, at 36-38 week, 2-3 days after delivery
Title
Requirement for insulin therapy
Description
Week of onset
Time Frame
At baseline, at 24-26 week, at 36-38 week, 2-3 days after delivery
Title
Requirement for insulin therapy
Description
Dose of insulin
Time Frame
At baseline, at 24-26 week, at 36-38 week, 2-3 days after delivery
Title
Quality of sleep
Description
Hours of deep sleep measured through the armband
Time Frame
At baseline, at 24-26 week, at 36-38 week, 2-3 days after delivery
Title
Duration of sleep
Description
Measured in hours through the armband
Time Frame
At baseline, at 24-26 week, at 36-38 week, 2-3 days after delivery
Title
Onset of hypertension / preeclampsia
Time Frame
At delivery
Title
Time of delivery
Time Frame
At delivery
Title
Mode of delivery
Time Frame
At delivery
Title
Complications during delivery
Description
Surgery and/or hemorrhage >500ml and/or shoulder dystocia
Time Frame
At delivery
Title
Apgar score
Time Frame
Within 1 hour after delivery
Title
Newborn's weight
Time Frame
Within 1 hour after delivery
Title
Newborn's sex
Time Frame
Within 1 hour after delivery
Title
Newborn's abdomen / head ratio
Time Frame
2-3 days after delivery
Title
Newborn's skinfold thickness at birth
Time Frame
2-3 days after delivery
Title
Neonatal hypoglycemia
Description
Neonatal hypoglycemia (measured in mg/dl) that requires therapy
Time Frame
Within 24 hours from delivery
Title
Neonatal bilirubinemia
Description
Measured in mg/dl
Time Frame
At delivery, 2-3 days after delivery
Title
Neonatal complications
Description
Respiratory Distress Syndrome, Necrotizing Enterocolitis, Retinopathy of prematurity, Bronchopulmonary Dysplasia, Neonatal Death
Time Frame
2-3 days after delivery
Title
Admission to Neonatal Intensive Care Unit (NICU)
Description
Admission to NICU
Time Frame
Within 24 hours after delivery
Title
Admission to Neonatal Intensive Care Unit (NICU)
Description
Duration of stay at the NICU
Time Frame
Within 24 hours after delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
Mother-Infant Department, University of Modena and Reggio Emilia, Italy
City
Modena
ZIP/Postal Code
41124
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabio Fachhinetti, MD
Phone
0039 0594222512
Email
facchi@unimore.it
First Name & Middle Initial & Last Name & Degree
Elisabetta Petrella, MD
First Name & Middle Initial & Last Name & Degree
Valeria Tamborrino, MD

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs