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Lactobacillus Rhamnosus and PCOS Treatment (ProjectPCOS)

P

Poznan University of Life Sciences

Status

Completed

Conditions

Hyperandrogenism
Polycystic Ovary Syndrome
Insulin Resistance
Obesity

Treatments

Dietary Supplement: Dietary group
Dietary Supplement: Lactobacillus group

Study type

Interventional

Funder types

Other

Identifiers

NCT03902301
Project PCOS

Details and patient eligibility

About

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.

Enrollment

80 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

80 participants in 2 patient groups

Dietary group
Active Comparator group
Description:
A diet based on general recommendations for people with insulin resistance for 20 weeks.
Treatment:
Dietary Supplement: Dietary group
Lactobacillus rhamnosus group
Experimental 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.
Treatment:
Dietary Supplement: Lactobacillus group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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