Polycystic Ovarian SyndromePhase 1/2NCT04029805
Evaluation of a Combination of a Plant Extract and a Probiotic on Glucidic Metabolism in Women With PCOS and High Insulin Levels
A Phase 1/2 study testing Combination of a plant extract (BSL_EP044) and Lactobacillus BSL_PS6 in people with Polycystic Ovarian Syndrome and Insulin Resistance, run by Biosearch S.A. at 1 site in Spain.
Trial summary
The aim of the present study is to evaluate the effect of the combination of a plant extract (BSL_EP044) and Lactobacillus BSL_PS6 on parameters of the glucidic metabolism, anthropometric parameters, hormonal levels and the menstrual cycle in women with polycystic ovary syndrome and high insulin levels. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Polycystic Ovarian Syndrome, Insulin Resistance
- What is being tested?
- Combination of a plant extract (BSL_EP044) and Lactobacillus BSL_PS6
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteSpain
- Study dates
- 29 May 2019to 30 Aug 2020
- Phase
- Phase 1/2
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being diagnosed with polycystic ovarian syndrome according to the Rotterdam criteria.
- HOMA values between 2.5 and 3.
- Body mass index of less than 35 kg/m2.
- Accept freely to participate in the study and sign the informed consent document.
Who cannot join
- Women in treatment with oral antidiabetics.
- Being pregnant or intending to get pregnant.
- Be in fertility treatment.
- To suffer from other diseases that affect the hormonal response or that could interfere with the glucidic metabolism.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effect of a Combination of a Plant Extract (BSL_EP044) and Lactobacillus BSL_PS6 on Glucidic Metabolism in Women Suffering From Polycystic Ovary Syndrome and High Insulin Levels
The aim of the present study is to evaluate the effect of the combination of a plant extract (BSL_EP044) and Lactobacillus BSL_PS6 on parameters of the glucidic metabolism, anthropometric parameters, hormonal levels and the menstrual cycle in women with polycystic ovary syndrome and high insulin levels.
Read the detailed description
Polycystic ovary syndrome (PCOS) is the most prevalent endocrinopathy in women, affecting 4-15% of those who are of childbearing age. It is a complex and heterogeneous disease in which the gynecological disorder coexist with metabolic problems such as insulin resistance.
The beneficial effect of the extract plant BSL-EP044 on glycemic metabolism in women with PCOS is widely studied and demonstrated and Lactobacillus BSL_PS6 appears to exert a synergistic effect by supplementing the effect of BSL-EP044. The hypothesis of our study is that the addition of the probiotic strain Lactobacillus BSL_PS6 to extract plant BSL-EP044 treatment may improve the beneficial effect of this one on insulin resistance and other metabolic alterations related to PCOS.
The main objective of the present study is to evaluate the effect of the combination of a Plant Extract (BSL_EP044) and Lactobacillus BSL_PS6 on parameters related to glycemic metabolism in women with polycystic ovary syndrome and high insulin levels.
- Conditions
- Polycystic Ovarian Syndrome, Insulin Resistance
- Being tested
- Combination of a plant extract (BSL_EP044) and Lactobacillus BSL_PS6, Placebo
- Keywords
- Polycystic ovarian syndrome, Extract plant, Probiotics, Insulin resistance
- Medical subject headings
- Polycystic Ovary Syndrome, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination of a plant extract (BSL_EP044) and Lactobacillus BSL_PS6Combination product
Each participant will consume 2 capsules daily, in the morning and at night without any restriction in the diet nor in their habits of life.
PlaceboCombination product
Each participant will consume 2 capsules daily, in the morning and at night without any restriction in the diet nor in their habits of life.
| Study group | Role | What they receive |
|---|---|---|
| Combination of a Plant Extract and a Probiotic | Experimental | Volunteers will take twice at day for 12 weeks a capsule containing the combination of a plant extract (BSL_EP044) and Lactobacillus BSL_PS6 Receives: Combination Product: Combination of a plant extract (BSL_EP044) and Lactobacillus BSL_PS6 |
| Placebo | Placebo comparator | Volunteers will take twice at day for 12 weeks a capsule containing maltodextrin. Receives: Combination Product: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma insulin
Levels of plasma insulin
Measured: 12 weeks
Plasma glucose
Levels of plasma glucose
Measured: 12 weeks
HOMA
Insulin sensitivity
Measured: 12 weeks
Secondary outcomes (2)
Total testosterone
Total testosterone
Measured: 12 weeks
Free testosterone
Free testosterone
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2019
- Study start29 May 2019
- Primary completion30 May 2020
- Study completion30 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovarian SyndromeStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biosearch S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicolás Mendoza, MD, PhD, Principal investigator, Professor of Gynecology at the Faculty of Medicine of the University of Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04029805
- Sponsor's protocol ID
- P044
- Status last verified
- Jul 2019
- First submitted
- 22 Jul 2019
- Last updated
- 10 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 10 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of a Combination of a Plant Extract (BSL_EP044) and Lactobacillus BSL_PS6 on Glucidic Metabolism in Women Suffering From Polycystic Ovary Syndrome and High Insulin Levels
- ClinicalTrials.gov ID
- NCT04029805
- Acronym / sponsor ID
- P044
- Conditions
- Polycystic Ovarian Syndrome, Insulin Resistance
- Keywords
- Polycystic ovarian syndrome, Extract plant, Probiotics, Insulin resistance
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Biosearch S.A.Industry (pharma, biotech, devices)
- Study start
- 29 May 2019 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 30 Aug 2020 (estimated)
- First posted
- 23 Jul 2019 (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 aim of the present study is to evaluate the effect of the combination of a plant extract (BSL_EP044) and Lactobacillus BSL_PS6 on parameters of the glucidic metabolism, anthropometric parameters, hormonal levels and the menstrual cycle in women with polycystic ovary syndrome and high insulin levels.
Detailed description
Polycystic ovary syndrome (PCOS) is the most prevalent endocrinopathy in women, affecting 4-15% of those who are of childbearing age. It is a complex and heterogeneous disease in which the gynecological disorder coexist with metabolic problems such as insulin resistance.
The beneficial effect of the extract plant BSL-EP044 on glycemic metabolism in women with PCOS is widely studied and demonstrated and Lactobacillus BSL_PS6 appears to exert a synergistic effect by supplementing the effect of BSL-EP044. The hypothesis of our study is that the addition of the probiotic strain Lactobacillus BSL_PS6 to extract plant BSL-EP044 treatment may improve the beneficial effect of this one on insulin resistance and other metabolic alterations related to PCOS.
The main objective of the present study is to evaluate the effect of the combination of a Plant Extract (BSL_EP044) and Lactobacillus BSL_PS6 on parameters related to glycemic metabolism in women with polycystic ovary syndrome and high insulin levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combination of a Plant Extract and a Probiotic | Experimental | Combination Product: Combination of a plant extract (BSL_EP044) and Lactobacillus BSL_PS6Volunteers will take twice at day for 12 weeks a capsule containing the combination of a plant extract (BSL_EP044) and Lactobacillus BSL_PS6 |
| Placebo | Placebo comparator | Combination Product: PlaceboVolunteers will take twice at day for 12 weeks a capsule containing maltodextrin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being diagnosed with polycystic ovarian syndrome according to the Rotterdam criteria.
- HOMA values between 2.5 and 3.
- Body mass index of less than 35 kg/m2.
- Accept freely to participate in the study and sign the informed consent document.
Key exclusion criteria (4 listed)
- Women in treatment with oral antidiabetics.
- Being pregnant or intending to get pregnant.
- Be in fertility treatment.
- To suffer from other diseases that affect the hormonal response or that could interfere with the glucidic metabolism.
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 |
|---|---|---|
| Combination of a plant extract (BSL_EP044) and Lactobacillus BSL_PS6Each participant will consume 2 capsules daily, in the morning and at night without any restriction in the diet nor in their habits of life. | Combination product | Combination of a Plant Extract and a Probiotic |
| PlaceboEach participant will consume 2 capsules daily, in the morning and at night without any restriction in the diet nor in their habits of life. | Combination product | Placebo |
Primary outcome
Plasma insulin
Time frame: 12 weeks
Levels of plasma insulin
Plasma glucose
Time frame: 12 weeks
Levels of plasma glucose
HOMA
Time frame: 12 weeks
Insulin sensitivity
2 secondary outcomes
Total testosterone
Time frame: 12 weeks
Free testosterone
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2020.
- 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. This study is not recruiting at the moment.
Nicolás Mendoza, MD, PhD principal investigator
Professor of Gynecology at the Faculty of Medicine of the University of Granada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Combination of a plant extract (BSL_EP044) and Lactobacillus BSL_PS6 in people with Polycystic Ovarian Syndrome and Insulin Resistance, run by Biosearch S.A. at 1 site in Spain.
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 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 10 Jul 2020. 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 Spain. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Juristo Fonollá, PhD (+34958240288, Juristo.FonollaJoya@biosearchlife.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma insulin (time frame: 12 weeks). The study lists 3 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 10 Jul 2020.