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

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ClinicalTrials.gov Identifier: NCT02768818
Recruitment Status : Unknown
Verified January 2016 by Prof. Facchinetti Fabio, University of Modena and Reggio Emilia.
Recruitment status was:  Recruiting
First Posted : May 11, 2016
Last Update Posted : May 11, 2016
Sponsor:
Information provided by (Responsible Party):
Prof. Facchinetti Fabio, University of Modena and Reggio Emilia

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).


Condition or disease Intervention/treatment Phase
Gestational Diabetes Mellitus in Pregnancy, Diet- Controlled Exercise Addiction High-Risk Pregnancy Dietary Modification Dietary Supplement: Probiotic VIVOMIXX™ Dietary Supplement: Placebo Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 205 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Modulation of the Intestinal Flora With the Probiotic VIVOMIXX™ in Pregnant Women at Risk of Metabolic Complications
Study Start Date : January 2016
Estimated Primary Completion Date : June 2016
Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
Probiotic VIVOMIXX™
Dietary Supplement: Probiotic VIVOMIXX™
The patients will be randomly assigned to the VIVOMIXX™ (intervention) or the control (placebo) group through a randomization list elaborated by a specific software.

Placebo Comparator: Control
Placebo
Dietary Supplement: Placebo
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 Measures :
  1. Maternal and newborn fecal microbiota changes (bifidobacteria and lactobacilli) and related enzymatic activity (alkaline sphingomyelinase and alkaline phosphatase) modifications [ Time Frame: At baseline, at 24-26 week, at 36-38 week, 2-3 days after delivery ]
    NMR-based metabolomics, microbiota and high performance liquid chromatography-mass spectrometry -HPLC/MS- of vitamins analysis

  2. Glucose metabolism changes [ Time Frame: At 24-26 week ]
    Positive Oral Glucose Tolerance Test


Secondary Outcome Measures :
  1. Weight changes [ Time Frame: At baseline, at 24-26 week, at 36-38 week, 2-3 days after delivery ]
    Measured in kg

  2. Maternal BMI [ Time Frame: At baseline, at 24-26 week, at 36-38 week, 2-3 days after delivery ]
    Measured in kg/m^2

  3. Waist/hip circumference ratio [ Time Frame: At baseline, at 24-26 week, at 36-38 week, 2-3 days after delivery ]
  4. Gestational weight gain [ Time Frame: At baseline, at 24-26 week, at 36-38 week, 2-3 days after delivery ]
    Measured in kg

  5. HOMA Index [ Time Frame: At baseline, at 24-26 week, at 36-38 week, 2-3 days after delivery ]
  6. HbA1c1 [ Time Frame: At baseline, at 24-26 week, at 36-38 week, 2-3 days after delivery ]
  7. glycemia [ Time Frame: At baseline, at 24-26 week, at 36-38 week, 2-3 days after delivery ]
  8. insulinemia [ Time Frame: At baseline, at 24-26 week, at 36-38 week, 2-3 days after delivery ]
  9. homocysteine plasmatic levels [ Time Frame: At baseline, at 24-26 week, at 36-38 week, 2-3 days after delivery ]
  10. Requirement for insulin therapy [ Time Frame: At baseline, at 24-26 week, at 36-38 week, 2-3 days after delivery ]
    Week of onset

  11. Requirement for insulin therapy [ Time Frame: At baseline, at 24-26 week, at 36-38 week, 2-3 days after delivery ]
    Dose of insulin

  12. Quality of sleep [ Time Frame: At baseline, at 24-26 week, at 36-38 week, 2-3 days after delivery ]
    Hours of deep sleep measured through the armband

  13. Duration of sleep [ Time Frame: At baseline, at 24-26 week, at 36-38 week, 2-3 days after delivery ]
    Measured in hours through the armband

  14. Onset of hypertension / preeclampsia [ Time Frame: At delivery ]
  15. Time of delivery [ Time Frame: At delivery ]
  16. Mode of delivery [ Time Frame: At delivery ]
  17. Complications during delivery [ Time Frame: At delivery ]
    Surgery and/or hemorrhage >500ml and/or shoulder dystocia

  18. Apgar score [ Time Frame: Within 1 hour after delivery ]
  19. Newborn's weight [ Time Frame: Within 1 hour after delivery ]
  20. Newborn's sex [ Time Frame: Within 1 hour after delivery ]
  21. Newborn's abdomen / head ratio [ Time Frame: 2-3 days after delivery ]
  22. Newborn's skinfold thickness at birth [ Time Frame: 2-3 days after delivery ]
  23. Neonatal hypoglycemia [ Time Frame: Within 24 hours from delivery ]
    Neonatal hypoglycemia (measured in mg/dl) that requires therapy

  24. Neonatal bilirubinemia [ Time Frame: At delivery, 2-3 days after delivery ]
    Measured in mg/dl

  25. Neonatal complications [ Time Frame: 2-3 days after delivery ]
    Respiratory Distress Syndrome, Necrotizing Enterocolitis, Retinopathy of prematurity, Bronchopulmonary Dysplasia, Neonatal Death

  26. Admission to Neonatal Intensive Care Unit (NICU) [ Time Frame: Within 24 hours after delivery ]
    Admission to NICU

  27. Admission to Neonatal Intensive Care Unit (NICU) [ Time Frame: Within 24 hours after delivery ]
    Duration of stay at the NICU



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

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): NCT02768818


Locations
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Italy
Mother-Infant Department, University of Modena and Reggio Emilia, Italy Recruiting
Modena, Italy, 41124
Contact: Fabio Fachhinetti, MD    0039 0594222512    facchi@unimore.it   
Sub-Investigator: Elisabetta Petrella, MD         
Sub-Investigator: Valeria Tamborrino, MD         
Sponsors and Collaborators
University of Modena and Reggio Emilia

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Responsible Party: Prof. Facchinetti Fabio, Chairman of Obstetrics and Gynecology Unit, University of Modena and Reggio Emilia
ClinicalTrials.gov Identifier: NCT02768818     History of Changes
Other Study ID Numbers: CE 91/14
First Posted: May 11, 2016    Key Record Dates
Last Update Posted: May 11, 2016
Last Verified: January 2016

Keywords provided by Prof. Facchinetti Fabio, University of Modena and Reggio Emilia:
Maternal Obesity Complicating Pregnancy

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes, Gestational
Pregnancy in Diabetics
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications