PreeclampsiaNCT06700044
Probiotic Supplementation During Pregnancy in Women With High-Risk Pregnancies
A study testing GutMagnific in people with Preeclampsia and Gut Dysbiosis, run by Region Skane at 1 site in Sweden.
Trial summary
Preeclampsia (PE) is a complication during pregnancy characterized by hypertension, organ damage, and inflammation, without an effective treatment. The underlying mechanisms causing the disease also remain partly unknown. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preeclampsia, Gut Dysbiosis
- What is being tested?
- GutMagnific
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteSweden
- Study dates
- 10 Dec 2024to Dec 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnant women ≥ 18 years old
- High risk of PE (≥ 1 high-risk factor, or ≥3 moderate risk factors according to the Swedish Society of Obstetrics and Gynecology (SFOG) 2019 guidelines); or low risk of PE (no high-risk factors, or \<3 moderate risk factors):
- High risk factors are:
- Auto-immune diseases such as SLE or anti-phospholipid syndrome
- Previous preeclampsia or eclampsia
- Previous hypertension of pregnancy with preterm birth before gestational week 34, growth restriction, intrauterine fetal death or ablatio
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- Type 1 or 2 diabetes
- Duplex (or triplex) pregnancy
- Kidney disease
- Chronic hypertension
- IVF with egg donation
- Moderate risk factors are:
- Nulliparity
- Heredity for preeclampsia (at least one of mother, maternal grandmother, or sister)
- BMI\>30
- Age\>40
- Pregnancy interval \>10 years
- Systolic blood pressure \>130 mmHg or diastolic blood pressure \> 80 mmHg at admission in antenatal maternity care
- African descent
- Verified obstructive sleep apnea
- Ability to give written informed consent
Who cannot join
- Enrollment in another clinical study
- Use of other probiotic supplements in the last 2 weeks before baseline, or during the course of the study
- Use of antibiotics in the last 6 weeks
- Current treatment with metformin, progesterone, or regular medical treatment which may impact study aim (e.g. laxatives)
- Immunosuppression
- Diabetes mellitus (type I and type II)
Show all 11Show fewer
- Inflammatory bowel disease
- Celiac disease
- Bad obstetric history
- Other serious conditions that might affect gut flora or capability of the subject to participate
- Language difficulties or difficulties understanding informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Region Skåne
Lund, 221 85
Stefan Hansson, +46706024476, stefan.hansson@med.lu.se
About this study
Official title: Assessing the Effects of Probiotic Supplementation in Women With High-Risk Pregnancies: A Randomized Controlled Trial
Preeclampsia (PE) is a complication during pregnancy characterized by hypertension, organ damage, and inflammation, without an effective treatment. The underlying mechanisms causing the disease also remain partly unknown. In this double-blind placebo-controlled study, the effects of probiotic dietary supplement GutMagnific during pregnancy will be assessed in pregnancies with a high risk of PE as well as low risk. The hypothesis is that probiotic dietary supplement GutMagnific can prevent or reduce the inflammatory response and clinical manifestations associated with PE through counteracting imbalances in the oral and gut microbiome composition.
Read the detailed description
PE is a leading cause of maternal and fetal morbidity and mortality worldwide, affecting 3-7% of pregnant women. PE is characterized by hypertension and organ damage manifesting after 20 gestational weeks, and is associated with an increased systemic inflammatory response in the mother. The clinical manifestations may vary greatly and are often more severe in early-onset PE (onset <34 gestational weeks) than late-onset PE (onset ≥34 gestational weeks). Severe features include blood-pressure ≥160/110 mmHg, severe organ dysfunction, stroke, and eclampsia. Placental failure is central in the pathophysiology of PE, although the underlying mechanisms causing the disease remain partly unknown. Current research, including a previous study conducted by the investigators, suggests that disturbances in the gut microbiome might be involved in the pathogenesis of PE, leading to a dysfunctional immune response and damaged gut barrier functions. The investigators' previous study also indicated that PE is associated with gastrointestinal symptoms.
GutMagnific is an evidence-based probiotic dietary supplement, shown to be effective in correcting disturbances in the gut microbiome, reduce inflammation and repair a damaged gut barrier. It was originally developed for treatment of irritable bowel syndrome (IBS). There is an overlap in immunological responses involved in PE and IBS, and women with IBS have a higher risk of developing PE. Therefore, the investigators expect that the product might also have positive effects in pregnant women with a high risk of PE.
- Conditions
- Preeclampsia, Gut Dysbiosis
- Being tested
- GutMagnific, Placebo
- Keywords
- preeclampsia, probiotics, microbiome, lactobacillus, pregnancy, GutMagnific
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GutMagnificDietary supplement
Participants will take one stick/10^9 CFU of probiotic dietary supplement GutMagnific per day from gestational week 12 until gestational week 37
PlaceboDietary supplement
Participants will take one stick/placebo per day from gestational week 12 until partus.
| Study group | Role | What they receive |
|---|---|---|
| High-risk probiotic | Active comparator | 50 pregnant women with high risk of developing PE will take one stick/10^9 CFU of probiotic dietary supplement GutMagnific per day from gestational week 12 until partus. Receives: Dietary Supplement: GutMagnific |
| High-risk placebo | Placebo comparator | 50 pregnant women with high risk of developing PE will take one stick/placebo per day from gestational week 12 until partus. Receives: Dietary Supplement: Placebo |
| Low-risk probiotic | Active comparator | 25 pregnant women with low risk of developing PE will take one stick/10^9 CFU of probiotic dietary supplement GutMagnific per day from gestational week 12 until partus. Receives: Dietary Supplement: GutMagnific |
| Low-risk placebo | Placebo comparator | 25 pregnant women with low risk of developing PE will take one stick/placebo per day from gestational week 12 until partus. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in oral and gut microbiota composition
Fecal and salivary samples will be analyzed using next-generation sequencing techniques to monitor possible changes related to probiotic supplement, and possible associations with obstetric outcome (especially PE incidence) will be assessed. Samples taken prior to, during and after probiotic treatment in the same participant will be compared.
Measured: Around gestational week 12 (baseline), 28, 37, and 6-8 weeks postpartum. In the event of a participant developing PE, samples will be taken at PE diagnosis as well.
Secondary outcomes (8)
Changes in gastrointestinal symptoms
A modified questionnaire for irritable bowel syndrome (IBS) symptoms will be filled in by participants grading different gastrointestinal symptoms from 1-10. Higher score indicates better condition.
Measured: At the baseline and every two weeks until 6-8 weeks postpartum.
Changes in blood pressure
Blood pressure measurements at standard midwife appointments in antenatal care.
Measured: At the baseline and continuously every 2-3 weeks from gestational week 24 throughout the pregnancy, and 6-8 weeks postpartum.
Differences in obstetric outcome
Incidence of adverse events during pregnancy, including PE, fetal growth restriction, gestational hypertension, gestational diabetes mellitus, and preterm birth.
Measured: Data will be collected from the Swedish Pregnancy Register (Graviditetsregistret) and/or medical records through study completion, an average of 6 months for term pregnancies.
Changes in oral glucose tolerance test results
Blood glucose levels before (fasting) and after standard oral glucose tolerance test will be assessed to study possible effects of probiotic supplementation.
Measured: Gestational week 28
Changes in circulatory Short-chain fatty acids (SCFAs) levels
Analysis of SCFAs levels in blood samples will be assessed to study possible effects of probiotic supplementation.
Measured: Around gestational week 12 (baseline), 28, 37, and 6-8 weeks postpartum. In the event of a participant developing PE, samples will be taken at PE diagnosis as well.
Changes in circulatory Lipopolysaccharide (LPS) levels
Analysis of LPS levels in blood samples will be assessed to study possible effects of probiotic supplementation.
Measured: Around gestational week 12 (baseline), 28, 37, and 6-8 weeks postpartum. In the event of a participant developing PE, samples will be taken at PE diagnosis as well.
Changes in metabolic parameters
Analysis of metabolic parameters such as ferritin will be assessed to study possible effects of probiotic supplementation.
Measured: Around gestational week 12 (baseline), 28, 37, and 6-8 weeks postpartum. In the event of a participant developing PE, samples will be taken at PE diagnosis as well.
Change in systemic cytokine levels
Cytokines relevant in PE including IL6, IL1, IL10, IL17, TNF-alfa and interferon-gamma will be measured in blood samples to monitor possible effects of probiotic supplementation on the maternal inflammatory response.
Measured: Around gestational week 12 (baseline), 28, 37, and 6-8 weeks postpartum. In the event of a participant developing PE, samples will be taken at PE diagnosis as well.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start10 Dec 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- More trials run by Region SkaneThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- ImmuneBiotech Medical Sweden AB
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06700044
- Sponsor's protocol ID
- Dnr 2024-03036-02
- Status last verified
- Dec 2024
- First submitted
- 10 Oct 2024
- Last updated
- 27 Dec 2024
- 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 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effects of Probiotic Supplementation in Women With High-Risk Pregnancies: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06700044
- Acronym / sponsor ID
- Dnr 2024-03036-02
- Conditions
- Preeclampsia, Gut Dysbiosis
- Keywords
- preeclampsia, probiotics, microbiome, lactobacillus, pregnancy, GutMagnific
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- ImmuneBiotech Medical Sweden AB
- Study start
- 10 Dec 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 21 Nov 2024 (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.
Preeclampsia (PE) is a complication during pregnancy characterized by hypertension, organ damage, and inflammation, without an effective treatment. The underlying mechanisms causing the disease also remain partly unknown. In this double-blind placebo-controlled study, the effects of probiotic dietary supplement GutMagnific during pregnancy will be assessed in pregnancies with a high risk of PE as well as low risk. The hypothesis is that probiotic dietary supplement GutMagnific can prevent or reduce the inflammatory response and clinical manifestations associated with PE through counteracting imbalances in the oral and gut microbiome composition.
Detailed description
PE is a leading cause of maternal and fetal morbidity and mortality worldwide, affecting 3-7% of pregnant women. PE is characterized by hypertension and organ damage manifesting after 20 gestational weeks, and is associated with an increased systemic inflammatory response in the mother. The clinical manifestations may vary greatly and are often more severe in early-onset PE (onset <34 gestational weeks) than late-onset PE (onset ≥34 gestational weeks). Severe features include blood-pressure ≥160/110 mmHg, severe organ dysfunction, stroke, and eclampsia. Placental failure is central in the pathophysiology of PE, although the underlying mechanisms causing the disease remain partly unknown. Current research, including a previous study conducted by the investigators, suggests that disturbances in the gut microbiome might be involved in the pathogenesis of PE, leading to a dysfunctional immune response and damaged gut barrier functions. The investigators' previous study also indicated that PE is associated with gastrointestinal symptoms.
GutMagnific is an evidence-based probiotic dietary supplement, shown to be effective in correcting disturbances in the gut microbiome, reduce inflammation and repair a damaged gut barrier. It was originally developed for treatment of irritable bowel syndrome (IBS). There is an overlap in immunological responses involved in PE and IBS, and women with IBS have a higher risk of developing PE. Therefore, the investigators expect that the product might also have positive effects in pregnant women with a high risk of PE.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| High-risk probiotic | Active comparator | Dietary Supplement: GutMagnific50 pregnant women with high risk of developing PE will take one stick/10^9 CFU of probiotic dietary supplement GutMagnific per day from gestational week 12 until partus. |
| High-risk placebo | Placebo comparator | Dietary Supplement: Placebo50 pregnant women with high risk of developing PE will take one stick/placebo per day from gestational week 12 until partus. |
| Low-risk probiotic | Active comparator | Dietary Supplement: GutMagnific25 pregnant women with low risk of developing PE will take one stick/10^9 CFU of probiotic dietary supplement GutMagnific per day from gestational week 12 until partus. |
| Low-risk placebo | Placebo comparator | Dietary Supplement: Placebo25 pregnant women with low risk of developing PE will take one stick/placebo per day from gestational week 12 until partus. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Pregnant women ≥ 18 years old
- High risk of PE (≥ 1 high-risk factor, or ≥3 moderate risk factors according to the Swedish Society of Obstetrics and Gynecology (SFOG) 2019 guidelines); or low risk of PE (no high-risk factors, or \<3 moderate risk factors):
- Ability to give written informed consent
Key exclusion criteria (11 listed)
- Enrollment in another clinical study
- Use of other probiotic supplements in the last 2 weeks before baseline, or during the course of the study
- Use of antibiotics in the last 6 weeks
- Current treatment with metformin, progesterone, or regular medical treatment which may impact study aim (e.g. laxatives)
- Immunosuppression
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 |
|---|---|---|
| GutMagnificParticipants will take one stick/10^9 CFU of probiotic dietary supplement GutMagnific per day from gestational week 12 until gestational week 37 | Dietary supplement | High-risk probiotic, Low-risk probiotic |
| PlaceboParticipants will take one stick/placebo per day from gestational week 12 until partus. | Dietary supplement | High-risk placebo, Low-risk placebo |
Primary outcome
Changes in oral and gut microbiota composition
Time frame: Around gestational week 12 (baseline), 28, 37, and 6-8 weeks postpartum. In the event of a participant developing PE, samples will be taken at PE diagnosis as well.
Fecal and salivary samples will be analyzed using next-generation sequencing techniques to monitor possible changes related to probiotic supplement, and possible associations with obstetric outcome (especially PE incidence) will be assessed. Samples taken prior to, during and after probiotic treatment in the same participant will be compared.
8 secondary outcomes
Changes in gastrointestinal symptoms
Time frame: At the baseline and every two weeks until 6-8 weeks postpartum.
Changes in blood pressure
Time frame: At the baseline and continuously every 2-3 weeks from gestational week 24 throughout the pregnancy, and 6-8 weeks postpartum.
Differences in obstetric outcome
Time frame: Data will be collected from the Swedish Pregnancy Register (Graviditetsregistret) and/or medical records through study completion, an average of 6 months for term pregnancies.
Changes in oral glucose tolerance test results
Time frame: Gestational week 28
Changes in circulatory Short-chain fatty acids (SCFAs) levels
Time frame: Around gestational week 12 (baseline), 28, 37, and 6-8 weeks postpartum. In the event of a participant developing PE, samples will be taken at PE diagnosis as well.
Changes in circulatory Lipopolysaccharide (LPS) levels
Time frame: Around gestational week 12 (baseline), 28, 37, and 6-8 weeks postpartum. In the event of a participant developing PE, samples will be taken at PE diagnosis as well.
Changes in metabolic parameters
Time frame: Around gestational week 12 (baseline), 28, 37, and 6-8 weeks postpartum. In the event of a participant developing PE, samples will be taken at PE diagnosis as well.
Change in systemic cytokine levels
Time frame: Around gestational week 12 (baseline), 28, 37, and 6-8 weeks postpartum. In the event of a participant developing PE, samples will be taken at PE diagnosis as well.
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 27 Dec 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GutMagnific in people with Preeclampsia and Gut Dysbiosis, run by Region Skane at 1 site in Sweden.
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 21 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 27 Dec 2024. 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 Sweden. 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.
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?
Contact Stefan R Hansson, Professor (+46 70 6024476, stefan.hansson@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in oral and gut microbiota composition (time frame: Around gestational week 12 (baseline), 28, 37, and 6-8 weeks postpartum. In the event of a participant developing PE, samples will be taken at PE diagnosis as well.). 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 27 Dec 2024.