Clinical trial · Interventional
Lactobacillus Rhamnosus and PCOS Treatment
The Effect of Lactobacillus Rhamnosus Supplementation on Body Mass, Hyperandrogenism and Insulin Resistance in Overweight and Obese Polycystic Ovary Syndrome Women - Randomized Nutritional Study
NCT03902301CI-TRIAL-00058049ProjectPCOScompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The effect of Lactobacillus rhamnosus supplementation on body weight, hyperandrogenism and insulin resistance in overweight and obesity women with Polycystic Ovary Syndrome will be analysed.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hyperandrogenism | — | UNRESOLVED | — |
| Insulin Resistance | — | UNRESOLVED | — |
| Obesity | — | UNRESOLVED | — |
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dietary group | Dietary Supplement | — | UNRESOLVED |
| Lactobacillus group | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Dietary group
- description
- A diet based on general recommendations for people with insulin resistance for 20 weeks.
- interventionNames
- Dietary Supplement: Dietary group
- type
- EXPERIMENTAL
- label
- Lactobacillus rhamnosus group
- description
- Lactobacillus rhamnosus for 20 weeks, (2x 6×10 9 CFU/per capsulex); A diet based on general recommendations for people with insulin resistance.
- interventionNames
- Dietary Supplement: Lactobacillus group
Primary outcomes (13)
- measure
- Insulin Resistance
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.