Dietary Modification Clinical Trial
Official title:
Modulation of the Intestinal Flora With the Probiotic VIVOMIXX™ in Pregnant Women at Risk of Metabolic Complications
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).
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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
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