Obesity & OverweightNCT07921940
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
A study testing OMNi-BiOTiC® METAtox in people with Obesity & Overweight and Gestational Diabetes Mellitus (GDM), run by Medical University of Vienna at 1 site in Austria.
Trial summary
The goal of this clinical trial is to learn if taking a probiotic supplement during pregnancy improves the body's response to insulin (insulin sensitivity) in pregnant women who were overweight or obese before pregnancy (body mass index ≥25 kg/m2). Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Obesity & Overweight, Gestational Diabetes Mellitus (GDM), Insulin Resistance
- What is being tested?
- OMNi-BiOTiC® METAtox
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteAustria
- Study dates
- 8 Oct 2024to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women aged 18 to 50 years
- Gestational age 12+0 to 15+6 at inclusion
- Preconceptional body mass index ≥25 kg/m2
- Written informed consent
Who cannot join
- Any acute illness within 2 weeks prior to the study
- Preconceptional diabetes (type 1, type 2 or others)
- Preconceptional endocrine disorder (Cushing Syndrome, M. Addison)
- Status post bariatric surgery
- HIV or hepatitis infection
- Severe liver or kidney dysfunction
- Current malignant tumors
- Participation in another interventional study
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Obstetrics and Gynecology, Division of Obstetrics and Feto-maternal Medicine, Medical University of Vienna
Vienna, 1090
About this study
Official title: To Assess the Possible Influence of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy - a Pilot Study
The goal of this clinical trial is to learn if taking a probiotic supplement during pregnancy improves the body's response to insulin (insulin sensitivity) in pregnant women who were overweight or obese before pregnancy (body mass index ≥25 kg/m2). Reduced insulin sensitivity is common in these women and increases the risk of gestational diabetes mellitus and excessive fetal growth. Growing evidence suggests that the bacteria in the gut (gut microbiome) play a role in regulating blood sugar and insulin action.
The main questions it aims to answer are:
Read more
- Does a daily probiotic supplement improve insulin sensitivity in mid-pregnancy?
- Does it affect blood sugar levels, insulin production, the development of gestational diabetes mellitus, fetal growth and the gut bacteria of mothers and newborns?
Participants will:
- Take one sachet of the probiotic OMNi-BiOTiC® METAtox twice daily from early pregnancy until delivery (probiotic group only)
- Attend three study visits in early, mid and late pregnancy with blood tests, an oral glucose tolerance test (early and mid pregnancy), measurements of weight and blood pressure, and questionnaires on diet and physical activity
- Wear a glucose sensor on the upper arm for 10 days after each visit
- Provide stool samples at each visit and a first stool sample of their newborn
- Have fetal growth checked by ultrasound and pregnancy and birth outcomes recorded
Read the detailed description
Single-center, open-label, randomized controlled pilot study at the Department of Obstetrics and Gynecology, Division of Obstetrics and Feto-Maternal Medicine, Medical University of Vienna. Participants are randomized 1:1 using minimization method to balance groups according to preconceptional body mass index (25-29.9 vs. ≥30 kg/m2).
Study visits take place at 12+0 to 15+6 weeks of gestation (V1), 24+0 to27+6 (V2) and 35+0 to 37+6 (V3).
V1: anthropometric measurements of the mother including information on weight gain during gestation, fasting blood samples, oral glucose tolerance test (OGTT), continuous glucose monitoring (CGM) for 10 days, dietary and physical activity questionnaires, maternal stool sample, randomization to intervention and control group. Women in the intervention group will take probiotics (OMNi-BiOTiC® METAtox) twice a day starting from V1 until delivery.
V2: anthropometric measurement, fasting blood samples, OGTT, fetal ultrasound, CGM for 10 days, dietary and physical activity questionnaires, maternal stool sample.
V3: anthropometric measurements, fasting blood samples, fetal ultrasound, CGM for 10 days, dietary and physical activity questionnaires, maternal stool sample.
At delivery: recording of obstetric and neonatal outcomes (mode of delivery, birth weight and length with percentiles, APGAR score, shoulder dystocia, neonatal hypoglycemia, admission to neonatal intensive care unit, umbilical cord sampling (blood glucose, insulin, c-peptide, pH, base excess), collection of the first neonatal stool (meconium).
As a pilot study, all analyses are exploratory and intended to generate effect estimates and hypotheses for future trials.
- Conditions
- Obesity & Overweight, Gestational Diabetes Mellitus (GDM), Insulin Resistance, Maternal Obesity Complicating Pregnancy
- Being tested
- OMNi-BiOTiC® METAtox
- Keywords
- probiotics, gut microbiome, pregnancy, insulin sensitivity, gestational diabetes mellitus, oral glucose tolerance test, continuous glucose monitoring
- Medical subject headings
- Obesity, Overweight, Diabetes, Gestational, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OMNi-BiOTiC® METAtoxDietary supplement
Multispecies probiotic containing 9 specially selected bacterial strains (Lactobacillus casei W56, Lactobacillus acidophilus 5 W37, Lactobacillus brevis W63, Lactococcus lactis W58, Lactococcus lactis W19, Bifidobacterium lactis W52, Lactobacillus salivarius W24, Bifidobacterium lactis W51, Bifidobacterium bifidum W23) at a concentration of 7.5 * 109 cfu (colony forming units) per portion (= 3 g). The intervention group will take one sachet of OMNi-BiOTiC® METAtox twice daily (in the morning and in the evening) before a meal. The dosing interval should be approximately 12 hours, and the intake is to be carried out continuously until delivery. The contents of one sachet must be stirred into a minimum of 100 ml of water. After an activation time of at least 1 minute, the suspension must be stirred again and then consumed.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic supplementation | Experimental | Women with a preconceptional BMI ≥25 kg/m2 taking one sachet of OMNi-BiOTiC® METAtox twice a day starting from randomization (12+0 to 15+6 weeks of gestation) until delivery. Receives: Dietary Supplement: OMNi-BiOTiC® METAtox |
| Control | No intervention | Women with a preconceptional BMI ≥25 kg/m2 receiving standard prenatal care without probiotic supplementation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity assessed by the PREDIM index
Insulin sensitivity will be assessed by the Predicted M index (PREDIM), derived from a 2-h 75g oral glucose tolerance test and compared between groups.
Measured: 12+0 to 15+6 (V1) and 24+0 to 27+6 (V2) weeks of gestation
Secondary outcomes (12)
Further insulin sensitivity and insulin resistance indices
Insulin sensitivity and insulin resistance indices (OGIS, Matsuda Index, HOMA-IR, QUICKI) derived from a 2-h 75g oral glucose tolerance test and compared between groups.
Measured: 12+0 to 15+6 (V1) and 24+0 to 27+6 (V2) weeks of gestation
Insulin secretion and beta-cell function indices
Insulin secretion and beta-cell function indices (insulinogenic index, oral disposition index) derived from a 2-h 75g oral glucose tolerance test and compared between groups.
Measured: 12+0 to 15+6 (V1) and 24+0 to 27+6 (V2) weeks of gestation
Glycemic profile assessed by continuous glucose monitoring
Mean glucose and percentage of time in range (63-140mg/dL), above, range and below range over 10 days continuous glucose monitoring
Measured: 12+0 to 15+6 (V1), 24+0 to 27+6 (V2) and 35+0 to 37+6 (V3) weeks of gestation
Fetal growth parameters assessed by ultrasound
Head circumference, biparietal diameter, abdominal circumference, abdominal fat thickness, femur length, and estimated fetal weight, expressed as absolute values and gestational age-specific percentiles.
Measured: 24+0 to 27+6 (V2) and 35+0 to 37+6 (V3) weeks of gestation
Umbilical cord blood glucose
Glucose concentration (mg/dL) in umbilical cord blood.
Measured: At delivery
Umbilical cord blood insulin
Insulin concentration (µU/ml) in umbilical cord blood.
Measured: At delivery.
Umbilical cord blood C-peptide
C-peptide concentration (ng/ml) in umbilical cord blood.
Measured: At delivery.
Umbilical cord blood pH
Arterial umbilical cord blood pH.
Measured: At delivery.
Umbilical cord blood base excess
Arterial umbilical cord blood base excess (mmol/L).
Measured: At delivery.
Birth weigth percentile and proportion of large- and small-for-gestational-age newborns
Sex- and gestational age-adjusted birth weight percentile, large for gestational age defined as >90th percentile, small for gestational age as <10th percentile
Measured: At delivery
Obstetric and neonatal outcomes
Mode of delivery, APGAR score, shoulder dystocia, neonatal hypoglycemia, admission to neonatal intensive care unit
Measured: From delivery up to 48 hours postpartum
Maternal and neonatal gut microbiome composition
Bacterial and fungal composition of maternal stool and neonatal meconiumassessed by 16S rRNA and ITS amplicon sequencing
Measured: Maternal: 12+0 to 15+6 (V1), 24+0 to 27+6 (V2) and 35+0 to 37+6 (V3) weeks of gestation Neonatal: first stool after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start8 Oct 2024
- Primary completion26 Oct 2026
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- Institut AllergoSan Pharma GmbH, Istituto di Neuroscienze Consiglio Nazionale delle Ricerche
- Responsible party
- Principal investigator, Christian Göbl, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07921940
- Sponsor's protocol ID
- EK-Nr. 1813/2024
- Status last verified
- Nov 2026
- First submitted
- 16 Oct 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Assess the Possible Influence of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy - a Pilot Study
- ClinicalTrials.gov ID
- NCT07921940
- Acronym / sponsor ID
- EK-Nr. 1813/2024
- Conditions
- Obesity & Overweight, Gestational Diabetes Mellitus (GDM), Insulin Resistance, Maternal Obesity Complicating Pregnancy
- Keywords
- probiotics, gut microbiome, pregnancy, insulin sensitivity, gestational diabetes mellitus, oral glucose tolerance test, continuous glucose monitoring
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- Institut AllergoSan Pharma GmbH, Istituto di Neuroscienze Consiglio Nazionale delle Ricerche
- Study start
- 8 Oct 2024 (actual)
- Primary completion
- 26 Oct 2026 (actual)
- Study completion
- Feb 2027 (estimated)
- First posted
- 6 Nov 2026 (actual)
- 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 goal of this clinical trial is to learn if taking a probiotic supplement during pregnancy improves the body's response to insulin (insulin sensitivity) in pregnant women who were overweight or obese before pregnancy (body mass index ≥25 kg/m2). Reduced insulin sensitivity is common in these women and increases the risk of gestational diabetes mellitus and excessive fetal growth. Growing evidence suggests that the bacteria in the gut (gut microbiome) play a role in regulating blood sugar and insulin action.
The main questions it aims to answer are:
- Does a daily probiotic supplement improve insulin sensitivity in mid-pregnancy?
- Does it affect blood sugar levels, insulin production, the development of gestational diabetes mellitus, fetal growth and the gut bacteria of mothers and newborns?
Participants will:
- Take one sachet of the probiotic OMNi-BiOTiC® METAtox twice daily from early pregnancy until delivery (probiotic group only)
- Attend three study visits in early, mid and late pregnancy with blood tests, an oral glucose tolerance test (early and mid pregnancy), measurements of weight and blood pressure, and questionnaires on diet and physical activity
- Wear a glucose sensor on the upper arm for 10 days after each visit
- Provide stool samples at each visit and a first stool sample of their newborn
- Have fetal growth checked by ultrasound and pregnancy and birth outcomes recorded
Detailed description
Single-center, open-label, randomized controlled pilot study at the Department of Obstetrics and Gynecology, Division of Obstetrics and Feto-Maternal Medicine, Medical University of Vienna. Participants are randomized 1:1 using minimization method to balance groups according to preconceptional body mass index (25-29.9 vs. ≥30 kg/m2).
Study visits take place at 12+0 to 15+6 weeks of gestation (V1), 24+0 to27+6 (V2) and 35+0 to 37+6 (V3).
V1: anthropometric measurements of the mother including information on weight gain during gestation, fasting blood samples, oral glucose tolerance test (OGTT), continuous glucose monitoring (CGM) for 10 days, dietary and physical activity questionnaires, maternal stool sample, randomization to intervention and control group. Women in the intervention group will take probiotics (OMNi-BiOTiC® METAtox) twice a day starting from V1 until delivery.
V2: anthropometric measurement, fasting blood samples, OGTT, fetal ultrasound, CGM for 10 days, dietary and physical activity questionnaires, maternal stool sample.
V3: anthropometric measurements, fasting blood samples, fetal ultrasound, CGM for 10 days, dietary and physical activity questionnaires, maternal stool sample.
At delivery: recording of obstetric and neonatal outcomes (mode of delivery, birth weight and length with percentiles, APGAR score, shoulder dystocia, neonatal hypoglycemia, admission to neonatal intensive care unit, umbilical cord sampling (blood glucose, insulin, c-peptide, pH, base excess), collection of the first neonatal stool (meconium).
As a pilot study, all analyses are exploratory and intended to generate effect estimates and hypotheses for future trials.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic supplementation | Experimental | Dietary Supplement: OMNi-BiOTiC® METAtoxWomen with a preconceptional BMI ≥25 kg/m2 taking one sachet of OMNi-BiOTiC® METAtox twice a day starting from randomization (12+0 to 15+6 weeks of gestation) until delivery. |
| Control | No intervention | –Women with a preconceptional BMI ≥25 kg/m2 receiving standard prenatal care without probiotic supplementation. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Pregnant women aged 18 to 50 years
- Gestational age 12+0 to 15+6 at inclusion
- Preconceptional body mass index ≥25 kg/m2
- Written informed consent
Key exclusion criteria (8 listed)
- Any acute illness within 2 weeks prior to the study
- Preconceptional diabetes (type 1, type 2 or others)
- Preconceptional endocrine disorder (Cushing Syndrome, M. Addison)
- Status post bariatric surgery
- HIV or hepatitis infection
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 |
|---|---|---|
| OMNi-BiOTiC® METAtoxMultispecies probiotic containing 9 specially selected bacterial strains (Lactobacillus casei W56, Lactobacillus acidophilus 5 W37, Lactobacillus brevis W63, Lactococcus lactis W58, Lactococcus lactis W19, Bifidobacterium lactis W52, Lactobacillus salivarius W24, Bifidobacterium lactis W51, Bifidobacterium bifidum W23) at a concentration of 7.5 * 109 cfu (colony forming units) per portion (= 3 g). The intervention group will take one sachet of OMNi-BiOTiC® METAtox twice daily (in the morning and in the evening) before a meal. The dosing interval should be approximately 12 hours, and the intake is to be carried out continuously until delivery. The contents of one sachet must be stirred into a minimum of 100 ml of water. After an activation time of at least 1 minute, the suspension must be stirred again and then consumed. | Dietary supplement | Probiotic supplementation |
Primary outcome
Insulin sensitivity assessed by the PREDIM index
Time frame: 12+0 to 15+6 (V1) and 24+0 to 27+6 (V2) weeks of gestation
Insulin sensitivity will be assessed by the Predicted M index (PREDIM), derived from a 2-h 75g oral glucose tolerance test and compared between groups.
12 secondary outcomes
Further insulin sensitivity and insulin resistance indices
Time frame: 12+0 to 15+6 (V1) and 24+0 to 27+6 (V2) weeks of gestation
Insulin secretion and beta-cell function indices
Time frame: 12+0 to 15+6 (V1) and 24+0 to 27+6 (V2) weeks of gestation
Glycemic profile assessed by continuous glucose monitoring
Time frame: 12+0 to 15+6 (V1), 24+0 to 27+6 (V2) and 35+0 to 37+6 (V3) weeks of gestation
Fetal growth parameters assessed by ultrasound
Time frame: 24+0 to 27+6 (V2) and 35+0 to 37+6 (V3) weeks of gestation
Umbilical cord blood glucose
Time frame: At delivery
Umbilical cord blood insulin
Time frame: At delivery.
Umbilical cord blood C-peptide
Time frame: At delivery.
Umbilical cord blood pH
Time frame: At delivery.
Umbilical cord blood base excess
Time frame: At delivery.
Birth weigth percentile and proportion of large- and small-for-gestational-age newborns
Time frame: At delivery
Obstetric and neonatal outcomes
Time frame: From delivery up to 48 hours postpartum
Maternal and neonatal gut microbiome composition
Time frame: Maternal: 12+0 to 15+6 (V1), 24+0 to 27+6 (V2) and 35+0 to 37+6 (V3) weeks of gestation Neonatal: first stool after birth
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No
Related trials for Obesity & Overweight
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
A Pilot Factorial Trial of an Integrated Lifestyle Intervention
Physical Inactivity, Overweight and Obesity
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OMNi-BiOTiC® METAtox in people with Obesity & Overweight and Gestational Diabetes Mellitus (GDM), run by Medical University of Vienna at 1 site in Austria.
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 4 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 6 Nov 2026. 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 Austria. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin sensitivity assessed by the PREDIM index (time frame: 12+0 to 15+6 (V1) and 24+0 to 27+6 (V2) weeks of gestation). 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 6 Nov 2026.