Probiotic vs. placebo and metformin: probiotic dietary intervention in polycystic ovary syndrome - A randomized controlled trial.
Metformin
PCOS
Probiotic
RCT
Journal
BMC endocrine disorders
ISSN: 1472-6823
Titre abrégé: BMC Endocr Disord
Pays: England
ID NLM: 101088676
Informations de publication
Date de publication:
17 Apr 2023
17 Apr 2023
Historique:
received:
04
11
2022
accepted:
08
02
2023
medline:
18
4
2023
entrez:
16
4
2023
pubmed:
17
4
2023
Statut:
epublish
Résumé
Polycystic Ovary Syndrome (PCOS) is a very common endocrine disorder with a variety of symptoms. Current treatment options include the contraceptive pill as well as metformin, however both treatments are limited to specific symptoms and have common side effects. This phase IV study is a monocentric, double blinded randomized clinical trial comparing the effects of six months of probiotic intervention to a placebo, with an additional open-label metformin arm as a positive control in a total of 180 participants with PCOS. The first of three visits is the screening visit, where inclusion/exclusion criteria are assessed. At the first visit, they are randomised into one of the three treatment arms equally and receive their study medication. After six months, all assessments from the first two visits are repeated. The primary endpoint is the change in free testosterone levels after the intervention, while secondary endpoints include changes in hormonal and metabolic parameters associated with PCOS as well as the gut microbial composition and diversity after intervention. Based on new insights into the role of the gut microbiome in PCOS development, this study is exploring the potential of using probiotics to treat women with PCOS symptoms. If successful, this new therapy approach could open a new realm of possibilities for treating PCOS. To our knowledge, this is the first study comparing probiotic intervention with not only placebo treatment, but also metformin. This study has been approved by the ethics committee of the Medical University of Graz (EC number 32-230 ex 19/20). EudraCT number: 2020-000228-20. gov identifier: NCT04593459. Version 1.5 dated 29th November 2021.
Sections du résumé
BACKGROUND
BACKGROUND
Polycystic Ovary Syndrome (PCOS) is a very common endocrine disorder with a variety of symptoms. Current treatment options include the contraceptive pill as well as metformin, however both treatments are limited to specific symptoms and have common side effects.
METHODS
METHODS
This phase IV study is a monocentric, double blinded randomized clinical trial comparing the effects of six months of probiotic intervention to a placebo, with an additional open-label metformin arm as a positive control in a total of 180 participants with PCOS. The first of three visits is the screening visit, where inclusion/exclusion criteria are assessed. At the first visit, they are randomised into one of the three treatment arms equally and receive their study medication. After six months, all assessments from the first two visits are repeated. The primary endpoint is the change in free testosterone levels after the intervention, while secondary endpoints include changes in hormonal and metabolic parameters associated with PCOS as well as the gut microbial composition and diversity after intervention.
DISCUSSION
CONCLUSIONS
Based on new insights into the role of the gut microbiome in PCOS development, this study is exploring the potential of using probiotics to treat women with PCOS symptoms. If successful, this new therapy approach could open a new realm of possibilities for treating PCOS. To our knowledge, this is the first study comparing probiotic intervention with not only placebo treatment, but also metformin. This study has been approved by the ethics committee of the Medical University of Graz (EC number 32-230 ex 19/20).
REGISTRATION
BACKGROUND
EudraCT number: 2020-000228-20.
CLINICALTRIALS
RESULTS
gov identifier: NCT04593459.
PROTOCOL VERSION
METHODS
Version 1.5 dated 29th November 2021.
Identifiants
pubmed: 37062834
doi: 10.1186/s12902-023-01294-6
pii: 10.1186/s12902-023-01294-6
pmc: PMC10106320
doi:
Substances chimiques
Metformin
9100L32L2N
Banques de données
ClinicalTrials.gov
['NCT04593459']
Types de publication
Randomized Controlled Trial
Clinical Trial, Phase IV
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
82Informations de copyright
© 2023. The Author(s).
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