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Therapeutic Potential of a Synbiotic to Improve Mental Health in Subjects With Obesity.

RecruitingNAAges 18 Years - 65 YearsAllCelia Bañuls
NCT06901739 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Obese individuals are a particularly vulnerable population for mental health problems, especially depression and anxiety. The aim of this study is to evaluate whether the intake of a synbiotic, composed of prebiotics and beneficial intestinal bacterial strains, is capable of producing changes in the gut microbiota and its functionality, improving metabolic and inflammatory parameters, intestinal function and appetite control in patients with obesity and psychological disorders. In addition, the production of neurotransmitters at the level of the gut-brain axis will be studied, as well as mood and quality of life. For this purpose, a prospective, randomized, doubleblind, placebo-controlled intervention study will be carried out in patients with obesity (BMI=30-40 kg/m2) and symptoms of anxiety and/or depression, or patients with obesity but without these psychological disorders (n=120). T

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patients with BMI 30-40kg/m2, with at least 5 years of diagnosed obesity evolution. * Patients have had stable body weight (\<5% of body weight changes) during the 3 months prior to the study. * Participants between 18 and 65 years of age. Exclusion Criteria: * All patients with acute or chronic inflammatory diseases, neoplasic disease, secondary causes of obesity (uncontrolled hypothyroidism, Cushing's syndrome), or established liver and kidney failure (according to transaminase levels ±2 SD of the mean and estimated glomerular filtration rate using the CKD-EPI formula \>60), previous bariatric surgery, and women during pregancy or lactation, will be excluded. * Participants who have been treated with antibiotics 3 months prior to inclusion. * Patients with different psychiatric disorders apart from anxiety and/or depression, and also those who are already on antidepressants before the inclusion.
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What it tests

  • Synbiotic
  • Placebo
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Where

1 site
FISABIO
Valencia, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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