Probiotic Intervention in PCOS

NCT ID: NCT04593459

Last Updated: 2024-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-03
• Study Completion Date: 2023-10-16

Brief Summary

The investigators are conducting a double-blinded randomized controlled trial to determine whether a probiotic mixture is effective in reducing PCOS-related symptoms. For this purpose, 180 participants will be recruited in three intervention arms (Probiotic, Placebo and Metformin), with 60 participants per arm. The intervention period will last 6 months, with extensive medical history, blood work, urine and stool analysis at the beginning and the conclusion of the trial.

Conditions

Polycystic Ovary Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Probiotic

Probiotic product consisting of these 7 bacterial strains:

• Lactobacillus salivarius W57
• Lactobacillus casei W56
• Lactobacillus rhamnosus W71
• Lactococcus lactis W58
• Enterococcus faecium W54
• Lactobacillus plantarum W62
• Lactobacillus acidophilus W22

Additional ingredients: Corn starch, maltodextrin, fructo-oligosaccharides, galacto-oligosaccharides, polydextrose, plant proteins, potassium chloride, magnesium sulfate, bacterial strains, manganese sulfate, lactose, 2000 IU vitamin D

Participants ingest one sachet of powder (5 grams) in 200 ml of water per day for 6 months

Group Type: EXPERIMENTAL

Probiotic

Intervention Type: DIETARY_SUPPLEMENT

See Arm description

Placebo

Similar to probiotic product in optics and smell, less ingredients and no bacterial strains or vitamin D

Ingredients: Corn starch, maltodextrin, potassium chloride, magnesium sulphate, manganese sulphate

Group Type: PLACEBO_COMPARATOR

Probiotic Placebo

Intervention Type: DIETARY_SUPPLEMENT

See Arm description

Metformin

Metformin is an established drug for treating PCOS-related symptoms. The investigators are comparing the probiotic not only to a placebo group, but also to the benchmark treatment.

Participants in the metformin arm will start treatment with 500 mg daily for the first week, then increasing the dose to 2x500 mg daily for the duration of the intervention.

Group Type: ACTIVE_COMPARATOR

Metformin Hydrochloride

Intervention Type: DRUG

See Arm description

Interventions

Probiotic

See Arm description

Intervention Type: DIETARY_SUPPLEMENT

Metformin Hydrochloride

See Arm description

Intervention Type: DRUG

Probiotic Placebo

See Arm description

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Polycystic Ovary Syndrome diagnosed based on at least two out of three rotterdam criteria: hyperandrogenism, polycystic ovarian morphology, oligo-/anovulation
• signed informed consent

Exclusion Criteria

• Missing or withdrawn consent
• Hyperandrogenism of a cause other than PCOS (Cushing´s syndrome, hyperprolactinemia, adrenal tumours, congenital adrenal hyperplasia, rare genetic disorders)
• Pregnancy or nursing period (first 6 months after giving birth)
• Soy or other allergies with respect to study procedures
• Diabetes mellitus type 1
• Chronic inflammatory bowel disease, history of cancer in the gastrointestinal tract or acute gastrointestinal infection
• Any malignancies that required treatment within the last 3 years prior to study procedures
• Any other chronic disease requiring medical check-ups or hospital treatments at least once every three months (exception: diabetes mellitus type 2)
• Major surgery in the gastrointestinal tract (e.g. colectomy, gut segment excision with stoma surgery, Whipple´s surgery.) Surgical removal of the appendix and/or the gall bladder is NOT considered major surgery.
• Therapy with antidiabetic drugs (metformin, sulfonylureas, dipeptidyl peptidase 4 (DPP-4) inhibitors, Glucagon-like peptide 1 (GLP-1) analogs, sodium-glucose-cotransporter 2 (SGLT-2) inhibitors, insulin variants) within the last six months prior to study procedures
• Therapy with proton pump inhibitors within the last six months prior to study procedures
• Therapy with hormonal contraceptives or systemic (oral) intake of steroids within the last six months prior to study procedures
• Oral or intravenous therapy with antibiotics less than three months before the onset of study procedures
• Alcohol and/or drug abuse

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Institut AllergoSan

UNKNOWN

Sponsor Role: collaborator

Winclove Probiotics B.V.

INDUSTRY

Sponsor Role: collaborator

Medical University of Graz

OTHER

Sponsor Role: lead

Responsible Party

Barbara Obermayer-Pietsch

Professor, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Barbara Obermayer-Pietsch, Prof. MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Graz, Division of Endocrinology and Diabetology

Locations

Medical University of Graz, Division of Endocrinology and Diabetology

Graz, Styria, Austria

Countries

Austria

References

Lindheim L, Bashir M, Munzker J, Trummer C, Zachhuber V, Leber B, Horvath A, Pieber TR, Gorkiewicz G, Stadlbauer V, Obermayer-Pietsch B. Alterations in Gut Microbiome Composition and Barrier Function Are Associated with Reproductive and Metabolic Defects in Women with Polycystic Ovary Syndrome (PCOS): A Pilot Study. PLoS One. 2017 Jan 3;12(1):e0168390. doi: 10.1371/journal.pone.0168390. eCollection 2017.

Reference Type: BACKGROUND

PMID: 28045919 (View on PubMed)

Haudum C, Lindheim L, Ascani A, Trummer C, Horvath A, Munzker J, Obermayer-Pietsch B. Impact of Short-Term Isoflavone Intervention in Polycystic Ovary Syndrome (PCOS) Patients on Microbiota Composition and Metagenomics. Nutrients. 2020 Jun 1;12(6):1622. doi: 10.3390/nu12061622.

Reference Type: BACKGROUND

PMID: 32492805 (View on PubMed)

Borzan V, Riedl R, Obermayer-Pietsch B. Probiotic vs. placebo and metformin: probiotic dietary intervention in polycystic ovary syndrome - A randomized controlled trial. BMC Endocr Disord. 2023 Apr 17;23(1):82. doi: 10.1186/s12902-023-01294-6.

Reference Type: DERIVED

PMID: 37062834 (View on PubMed)

Other Identifiers

2020-000228-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

160120200001

Identifier Type: -

Identifier Source: org_study_id