PCOSNCT06761625
Changes in Hormonal Profile and Body Mass Index in Women With Polycystic Ovary Syndrome After Probiotic Intake
A study testing SanProbi® Barrier capsules in people with PCOS, run by Pomeranian Medical University Szczecin at 1 site in Poland.
Trial summary
Changes in hormonal profile and body mass index in women with polycystic ovary syndrome were analised after probiotic intake. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- PCOS
- What is being tested?
- SanProbi® Barrier capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 sitePoland
- Study dates
- 1 Dec 2019to 31 Dec 2021
- Phase
- Interventional
- 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 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women with PCOS, diagnosed based on Rotterdam ESHRE criteria
Who cannot join
- The patients with comorbidities such as diabetes mellitus type I and II, heart diseas-es, liver diseases, hypertension, hypothyroidism should be excluded from the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Changes in Hormonal Profile and Body Mass Index in Women With Polycystic Ovary Syndrome After Probiotic Intake: A 12-week Placebo Controlled and Randomized Clinical Study
Changes in hormonal profile and body mass index in women with polycystic ovary syndrome were analised after probiotic intake.
Read the detailed description
50 women with PCOS , diagnosed based on Rotterdam ESHRE criteria,were assigned to two groups - the probiotics one and the placebo one. Women from the probiotics group were given SanProbi® Barrier capsules. They were taking probiotics for 12 weeks. The placebo group received identical-looking capsules filled mainly with maize starch and maltodextrins. The study concentrates on analysing specific hormones before and after the intervention (giving the probiotics or a placebo to the patients). The serum samples were obtained on days 3-5 (early follicular phase) of menstrual cycle. In the laboratory studies, the following hormones were measured before and after 12-week intervention: Testosterone, Androstenedione, 17-hydroxyprogesterone (17(OH)P); follicle stimulating hormone (FSH), luteinising hormone (LH); estradiol (E2), prolactin (PRL), thyroid stimulating hormone (TSH), thyroxine (T4) and sex hormone binding globulin (SHBG). The weight and height were measured before and after 12-week intervention. BMI was also calculated.
- Conditions
- PCOS
- Being tested
- SanProbi® Barrier capsules, Placebo
- Keywords
- PCOS, probiotics, hormones, BMI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SanProbi® Barrier capsulesDietary supplement
The probiotic group received SanProbi® Barrier capsules
PlaceboOther
The placebo group received capsules filled mainly with maize starch and maltodextrins.
| Study group | Role | What they receive |
|---|---|---|
| Probiotics Intake | Experimental | The probiotic group received SanProbi® Barrier capsules Receives: Dietary Supplement: SanProbi® Barrier capsules |
| Placebo Intake | Placebo comparator | The placebo group received capsules filled mainly with maize starch and maltodextrins. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in hormonal profile after probiotics intake
The hormones will be measured before and after 12-week intervention: the main outcome measure will be androstenedione, prolactin, 17-hydroxyprogesterone and testosterone levels measured in ng/ml.
Measured: 12 weeks
Secondary outcomes (6)
Change in FSH and LH levels in women with polycystic ovary syndrome after probiotic intake
LH and FSH levels will be measured before and after 12 weeks of probiotics intake. They are measured in mIU/ml
Measured: 12 weeks
Change in Estradiol levels in women with polycystic ovary syndrome after probiotic intake
Estradiol levels will be measured before and after 12 weeks of probiotics intake. They are measured in pg/ml
Measured: 12 weeks
Changes in TSH levels in women with polycystic ovary syndrome after probiotic intake
TSH levels will be measured before and after 12 weeks of probiotics intake. They are measured in μIU/ml
Measured: 12 weeks
Changes in SHBG in women with polycystic ovary syndrome after probiotic intake
SHBG levels will be measured before and after 12 weeks of probiotics intake. They are measured in nmol/l
Measured: 12 weeks
Changes in DHEA-S levels in women with polycystic ovary syndrome after probiotic intake
DHEA-S levels will be measured before and after 12 weeks of probiotics intake. They are measured in μg/dl
Measured: 12 weeks
Changes in BMI in women with polycystic ovary syndrome after probiotic intake
BMI will be measured before and after 12 weeks of probiotics intake. Weight and height will be combined to report BMI in kg/m^2
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 posted7 Jan 2025
- Study start1 Dec 2019
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PCOSStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pomeranian Medical University Szczecin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06761625
- Sponsor's protocol ID
- 1/12/2024
- Status last verified
- Dec 2024
- First submitted
- 19 Dec 2024
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Hormonal Profile and Body Mass Index in Women With Polycystic Ovary Syndrome After Probiotic Intake: A 12-week Placebo Controlled and Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT06761625
- Acronym / sponsor ID
- 1/12/2024
- Conditions
- PCOS
- Keywords
- PCOS, probiotics, hormones, BMI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Pomeranian Medical University SzczecinUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 7 Jan 2025 (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.
Changes in hormonal profile and body mass index in women with polycystic ovary syndrome were analised after probiotic intake.
Detailed description
50 women with PCOS , diagnosed based on Rotterdam ESHRE criteria,were assigned to two groups - the probiotics one and the placebo one. Women from the probiotics group were given SanProbi® Barrier capsules. They were taking probiotics for 12 weeks. The placebo group received identical-looking capsules filled mainly with maize starch and maltodextrins. The study concentrates on analysing specific hormones before and after the intervention (giving the probiotics or a placebo to the patients). The serum samples were obtained on days 3-5 (early follicular phase) of menstrual cycle. In the laboratory studies, the following hormones were measured before and after 12-week intervention: Testosterone, Androstenedione, 17-hydroxyprogesterone (17(OH)P); follicle stimulating hormone (FSH), luteinising hormone (LH); estradiol (E2), prolactin (PRL), thyroid stimulating hormone (TSH), thyroxine (T4) and sex hormone binding globulin (SHBG). The weight and height were measured before and after 12-week intervention. BMI was also calculated.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotics Intake | Experimental | Dietary Supplement: SanProbi® Barrier capsulesThe probiotic group received SanProbi® Barrier capsules |
| Placebo Intake | Placebo comparator | Other: PlaceboThe placebo group received capsules filled mainly with maize starch and maltodextrins. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- women with PCOS, diagnosed based on Rotterdam ESHRE criteria
Key exclusion criteria (1 listed)
- The patients with comorbidities such as diabetes mellitus type I and II, heart diseas-es, liver diseases, hypertension, hypothyroidism should be excluded from the study
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 |
|---|---|---|
| SanProbi® Barrier capsulesThe probiotic group received SanProbi® Barrier capsules | Dietary supplement | Probiotics Intake |
| PlaceboThe placebo group received capsules filled mainly with maize starch and maltodextrins. | Other | Placebo Intake |
Primary outcome
Changes in hormonal profile after probiotics intake
Time frame: 12 weeks
The hormones will be measured before and after 12-week intervention: the main outcome measure will be androstenedione, prolactin, 17-hydroxyprogesterone and testosterone levels measured in ng/ml.
6 secondary outcomes
Change in FSH and LH levels in women with polycystic ovary syndrome after probiotic intake
Time frame: 12 weeks
Change in Estradiol levels in women with polycystic ovary syndrome after probiotic intake
Time frame: 12 weeks
Changes in TSH levels in women with polycystic ovary syndrome after probiotic intake
Time frame: 12 weeks
Changes in SHBG in women with polycystic ovary syndrome after probiotic intake
Time frame: 12 weeks
Changes in DHEA-S levels in women with polycystic ovary syndrome after probiotic intake
Time frame: 12 weeks
Changes in BMI in women with polycystic ovary syndrome after probiotic intake
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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.
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 SanProbi® Barrier capsules in people with PCOS, run by Pomeranian Medical University Szczecin at 1 site in Poland.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 7 Jan 2025. 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 Poland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in hormonal profile after probiotics intake (time frame: 12 weeks). 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 7 Jan 2025.