Lactobacillus Rhamnosus and PCOS Treatment (ProjectPCOS)
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ClinicalTrials.gov Identifier: NCT03902301 |
Recruitment Status :
Completed
First Posted : April 4, 2019
Last Update Posted : April 26, 2022
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Condition or disease | Intervention/treatment | Phase |
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Insulin Resistance Polycystic Ovary Syndrome Hyperandrogenism Obesity | Dietary Supplement: Lactobacillus group Dietary Supplement: Dietary group | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 80 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Investigator) |
Primary Purpose: | Treatment |
Official Title: | The Effect of Lactobacillus Rhamnosus Supplementation on Body Mass, Hyperandrogenism and Insulin Resistance in Overweight and Obese Polycystic Ovary Syndrome Women - Randomized Nutritional Study |
Actual Study Start Date : | April 1, 2018 |
Actual Primary Completion Date : | December 31, 2020 |
Actual Study Completion Date : | December 31, 2020 |

Arm | Intervention/treatment |
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Active Comparator: Dietary group
A diet based on general recommendations for people with insulin resistance for 20 weeks.
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Dietary Supplement: Dietary group
Nutritional intervention focused on the treatment of insulin resistance (35 subjects). |
Experimental: Lactobacillus rhamnosus group
Lactobacillus rhamnosus for 20 weeks, (2x 6×10 9 CFU/per capsulex); A diet based on general recommendations for people with insulin resistance.
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Dietary Supplement: Lactobacillus group
Nutrition intervention focused on the treatment of insulin resistance + Lactobacillus rhamnosus supplementation (6x10 9 of lactobacillus rhamnosus x 2 times a day) (35 people). |
- Insulin Resistance [ Time Frame: 20 weeks ]Fasting insulin concentration (uU/ml) will be measured before and after 2 hours of 75g glucose drink. Insulin resistance will be measured before and after 20 weeks of the intervention.
- Oral glucose test OGTT [ Time Frame: 20 weeks ]Fasting glucose concentration (mg/dL) will be measured before and after 2 hours of 75g glucose drink. OGTT will be measured before and after 20 weeks of the intervention. Fating glucose and fasting insulin concentrations will be combined to report HOMA-IR index (homeostatic model assessment of insulin resistance).
- Testosterone [ Time Frame: 20 weeks ]Testosterone (ng/mL) concentrations will measured at baseline and after 20 weeks of the intervention. Results of testosterone level and SHBG level will be combined to report FAI index (index of free androgen).
- DHEA-SO4 [ Time Frame: 20 weeks ]DHEA-SO4 (umol/L) concentrations will measured at baseline and after 20 weeks of the intervention. Results of testosterone level and SHBG level will be combined to report FAI index (index of free androgen).
- SHBG [ Time Frame: 20 weeks ]SHBG (nmol/L) concentrations will measured at baseline and after 20 weeks of the intervention. Results of testosterone level and SHBG level will be combined to report FAI index (index of free androgen).
- Free androgen index FAI [ Time Frame: 20 weeks ]Results of testosterone level and SHBG level will be combined to report FAI index (index of free androgen).
- Body weight [ Time Frame: 20 weeks ]Body weight (kg) will be assessment at baseline and after 20 weeks of the intervention.
- Body height [ Time Frame: Baseline ]Body height (cm) will be assessment at baseline of the intervention.
- Body composition [ Time Frame: 20 weeks ]Fat mass (%), fat free mass (%) will be assessment at baseline and after 20 weeks of the intervention.
- Blood lipid profile: cholesterole [ Time Frame: 20 weeks ]Cholesterole (mg/dL) will be measured at baseline and after 20 weeks of the intervention
- Blood lipid profile: triglicerydes [ Time Frame: 20 weeks ]Triglicerydes (mg/dL) will be measured at baseline and after 20 weeks of the intervention
- Blood lipid profile: high density lipoprotein [ Time Frame: 20 weeks ]High density lipoprotein HDL (mg/dL) will be measured at baseline and after 20 weeks of the intervention
- Blood lipid profile: low density lipoprotein [ Time Frame: 20 weeks ]Low density lipoprotein LDL (mg/dL) will be measured at baseline and after 20 weeks of the intervention
- Assessment of qualitative and quantitative of the microbiome [ Time Frame: 20 weeks ]Qualitative and quantitative determination of the composition of gut microbiota will be assessment at baseline and after 20 weeks of the intervention
- Assessment of B-glucuronidase and B-glucosiadase activity [ Time Frame: 20 weeks ]B-glucuronidase and B-glucosiadase activity in stoolen sample will be assessment at baseline and after 20 weeks of the intervention
- Assessment of short-chain fatty acids [ Time Frame: 20 weeks ]Assessment of short-chain fatty acids will be assessment at baseline and after 20 weeks of the intervention

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Ages Eligible for Study: | 18 Years to 40 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
- patients diagnosed with PCOS,
- BMI> 28 kg/m2 (overweight or obesity),
- patients not participating in other similar research programs at the same time,
- no previous operations on ovaries such as: laparoscopy, ovarian cautery etc.,
- written agreement to take part in the research.
Exlusion criteria:
- the use of antibiotics or probiotics within 6 months before the start of the experiment,
- the use of pharmacological agents or hormones that may affect the course of the menstrual cycle or metabolic rate within 3 months,
- the use of medicament that may affect on carbohydrate metabolism within 4 weeks,
- failure to comply with dietary recommendations established during the nutritional intervention,
- the use of weight loss supplements during the study,
- clinical diagnosis of digestive disease (for example: irritable bowel syndrome, ulcerative colitis, Crohn's disease, celiac disease),
- pregnancy and breast feeding.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03902301
Poland | |
Poznan University of Life Sciences | |
Poznan, Poland, 60-624 |
Responsible Party: | Karolina Łagowska, Principal Investigator (dr inż), Poznan University of Life Sciences |
ClinicalTrials.gov Identifier: | NCT03902301 |
Other Study ID Numbers: |
Project PCOS |
First Posted: | April 4, 2019 Key Record Dates |
Last Update Posted: | April 26, 2022 |
Last Verified: | April 2022 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Lactobacillus rhamnosus Polycystic Ovary Syndrome insulin resistance nutrition intervention probiotic |
Polycystic Ovary Syndrome Hyperandrogenism Insulin Resistance Syndrome Disease Pathologic Processes Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Ovarian Cysts Cysts |
Neoplasms Ovarian Diseases Adnexal Diseases Gonadal Disorders Endocrine System Diseases 46, XX Disorders of Sex Development Disorders of Sex Development Urogenital Abnormalities Adrenogenital Syndrome Congenital Abnormalities |