Gestational Diabetes Mellitus in Pregnancy, Diet- ControlledPhase 3NCT02768818
Modulation of the Intestinal Flora With the Probiotic VIVOMIXX™ in Pregnant Women at Risk of Metabolic Complications
A Phase 3 study testing Probiotic VIVOMIXX™ in people with Gestational Diabetes Mellitus in Pregnancy, Diet- Controlled and Exercise Addiction, run by University of Modena and Reggio Emilia at 1 site in Italy.
Trial summary
The investigators aimed at evaluating the effectiveness of probiotics ingestion in changing maternal microbiota and preventing gestational diabetes in overweight and obese women. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes Mellitus in Pregnancy, Diet- Controlled, Exercise Addiction, High-Risk Pregnancy
- What is being tested?
- Probiotic VIVOMIXX™
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 205 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2016to Dec 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Mother-Infant Department, University of Modena and Reggio Emilia, Italy
Modena, 41124
Fabio Fachhinetti, MD, 0039 0594222512, facchi@unimore.it
Elisabetta Petrella, MD
About this study
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).
Read the 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.
- Conditions
- Gestational Diabetes Mellitus in Pregnancy, Diet- Controlled, Exercise Addiction, High-Risk Pregnancy, Dietary Modification
- Being tested
- Probiotic VIVOMIXX™, Placebo
- Keywords
- Maternal Obesity Complicating Pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
PlaceboDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Probiotic VIVOMIXX™ Receives: Dietary Supplement: Probiotic VIVOMIXX™ |
| Control | Placebo comparator | Placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At baseline, at 24-26 week, at 36-38 week, 2-3 days after delivery
Glucose metabolism changes
Positive Oral Glucose Tolerance Test
Measured: At 24-26 week
Secondary outcomes (27)
Weight changes
Measured in kg
Measured: At baseline, at 24-26 week, at 36-38 week, 2-3 days after delivery
Maternal BMI
Measured in kg/m^2
Measured: At baseline, at 24-26 week, at 36-38 week, 2-3 days after delivery
Waist/hip circumference ratio
Measured: At baseline, at 24-26 week, at 36-38 week, 2-3 days after delivery
Gestational weight gain
Measured in kg
Measured: At baseline, at 24-26 week, at 36-38 week, 2-3 days after delivery
HOMA Index
Measured: At baseline, at 24-26 week, at 36-38 week, 2-3 days after delivery
HbA1c1
Measured: At baseline, at 24-26 week, at 36-38 week, 2-3 days after delivery
glycemia
Measured: At baseline, at 24-26 week, at 36-38 week, 2-3 days after delivery
insulinemia
Measured: At baseline, at 24-26 week, at 36-38 week, 2-3 days after delivery
homocysteine plasmatic levels
Measured: At baseline, at 24-26 week, at 36-38 week, 2-3 days after delivery
Requirement for insulin therapy
Week of onset
Measured: At baseline, at 24-26 week, at 36-38 week, 2-3 days after delivery
Requirement for insulin therapy
Dose of insulin
Measured: At baseline, at 24-26 week, at 36-38 week, 2-3 days after delivery
Quality of sleep
Hours of deep sleep measured through the armband
Measured: At baseline, at 24-26 week, at 36-38 week, 2-3 days after delivery
Duration of sleep
Measured in hours through the armband
Measured: At baseline, at 24-26 week, at 36-38 week, 2-3 days after delivery
Onset of hypertension / preeclampsia
Measured: At delivery
Time of delivery
Measured: At delivery
Mode of delivery
Measured: At delivery
Complications during delivery
Surgery and/or hemorrhage >500ml and/or shoulder dystocia
Measured: At delivery
Apgar score
Measured: Within 1 hour after delivery
Newborn's weight
Measured: Within 1 hour after delivery
Newborn's sex
Measured: Within 1 hour after delivery
Newborn's abdomen / head ratio
Measured: 2-3 days after delivery
Newborn's skinfold thickness at birth
Measured: 2-3 days after delivery
Neonatal hypoglycemia
Neonatal hypoglycemia (measured in mg/dl) that requires therapy
Measured: Within 24 hours from delivery
Neonatal bilirubinemia
Measured in mg/dl
Measured: At delivery, 2-3 days after delivery
Neonatal complications
Respiratory Distress Syndrome, Necrotizing Enterocolitis, Retinopathy of prematurity, Bronchopulmonary Dysplasia, Neonatal Death
Measured: 2-3 days after delivery
Admission to Neonatal Intensive Care Unit (NICU)
Admission to NICU
Measured: Within 24 hours after delivery
Admission to Neonatal Intensive Care Unit (NICU)
Duration of stay at the NICU
Measured: Within 24 hours after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2016 (estimated)
- Study startJan 2016
- Primary completionJun 2016 (estimated)
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes Mellitus in Pregnancy, Diet- ControlledStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 205 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Modena and Reggio Emilia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Facchinetti Fabio, University of Modena and Reggio Emilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02768818
- Sponsor's protocol ID
- CE 91/14
- Status last verified
- Jan 2016
- First submitted
- 20 Apr 2016
- Last updated
- 11 May 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of the Intestinal Flora With the Probiotic VIVOMIXX™ in Pregnant Women at Risk of Metabolic Complications
- ClinicalTrials.gov ID
- NCT02768818
- Acronym / sponsor ID
- CE 91/14
- Conditions
- Gestational Diabetes Mellitus in Pregnancy, Diet- Controlled, Exercise Addiction, High-Risk Pregnancy, Dietary Modification
- Keywords
- Maternal Obesity Complicating Pregnancy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 205 participants (estimated)
- Lead sponsor
- University of Modena and Reggio EmiliaUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Dec 2016
- First posted
- 11 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Dietary Supplement: Probiotic VIVOMIXX™Probiotic VIVOMIXX™ |
| Control | Placebo comparator | Dietary Supplement: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Dietary supplement | Intervention |
| PlaceboThe patients will be randomly assigned to the VIVOMIXX™ (intervention) or the control (placebo) group through a randomization list elaborated by a specific software. | Dietary supplement | Control |
Primary outcome
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
Glucose metabolism changes
Time frame: At 24-26 week
Positive Oral Glucose Tolerance Test
27 secondary outcomes
Weight changes
Time frame: At baseline, at 24-26 week, at 36-38 week, 2-3 days after delivery
Maternal BMI
Time frame: At baseline, at 24-26 week, at 36-38 week, 2-3 days after delivery
Waist/hip circumference ratio
Time frame: At baseline, at 24-26 week, at 36-38 week, 2-3 days after delivery
Gestational weight gain
Time frame: At baseline, at 24-26 week, at 36-38 week, 2-3 days after delivery
HOMA Index
Time frame: At baseline, at 24-26 week, at 36-38 week, 2-3 days after delivery
HbA1c1
Time frame: At baseline, at 24-26 week, at 36-38 week, 2-3 days after delivery
glycemia
Time frame: At baseline, at 24-26 week, at 36-38 week, 2-3 days after delivery
insulinemia
Time frame: At baseline, at 24-26 week, at 36-38 week, 2-3 days after delivery
homocysteine plasmatic levels
Time frame: At baseline, at 24-26 week, at 36-38 week, 2-3 days after delivery
Requirement for insulin therapy
Time frame: At baseline, at 24-26 week, at 36-38 week, 2-3 days after delivery
Requirement for insulin therapy
Time frame: At baseline, at 24-26 week, at 36-38 week, 2-3 days after delivery
Quality of sleep
Time frame: At baseline, at 24-26 week, at 36-38 week, 2-3 days after delivery
Duration of sleep
Time frame: At baseline, at 24-26 week, at 36-38 week, 2-3 days after delivery
Onset of hypertension / preeclampsia
Time frame: At delivery
Time of delivery
Time frame: At delivery
Mode of delivery
Time frame: At delivery
Complications during delivery
Time frame: At delivery
Apgar score
Time frame: Within 1 hour after delivery
Newborn's weight
Time frame: Within 1 hour after delivery
Newborn's sex
Time frame: Within 1 hour after delivery
Newborn's abdomen / head ratio
Time frame: 2-3 days after delivery
Newborn's skinfold thickness at birth
Time frame: 2-3 days after delivery
Neonatal hypoglycemia
Time frame: Within 24 hours from delivery
Neonatal bilirubinemia
Time frame: At delivery, 2-3 days after delivery
Neonatal complications
Time frame: 2-3 days after delivery
Admission to Neonatal Intensive Care Unit (NICU)
Time frame: Within 24 hours after delivery
Admission to Neonatal Intensive Care Unit (NICU)
Time frame: Within 24 hours after delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mother-Infant Department, University of Modena and Reggio Emilia, Italy
Modena, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Probiotic VIVOMIXX™ in people with Gestational Diabetes Mellitus in Pregnancy, Diet- Controlled and Exercise Addiction, run by University of Modena and Reggio Emilia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2016.