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

Launched by CELIA BAÑULS · Mar 23, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how a special blend of prebiotics and beneficial bacteria, called a synbiotic, can help improve mental health in people with obesity who also experience anxiety or depression. The goal is to see if taking this synbiotic for 12 weeks can positively affect gut health, appetite control, and overall mood. Researchers will study 120 participants, ages 18 to 65, who have a body mass index (BMI) between 30 and 40. To participate, individuals should have had stable weight for the past three months and a history of obesity for at least five years. However, those with certain health conditions, like chronic diseases or who have had recent antibiotic treatment, will not be eligible.

Participants in the trial will be divided into two groups: one group will take the synbiotic, while the other will receive a placebo (a pill that looks the same but has no active ingredients). Throughout the study, participants will receive personalized support for their mental and nutritional health and will undergo various assessments to measure changes in their weight, gut health, and mood. This trial aims to understand the connection between gut health and mental well-being, which could lead to new treatments for those struggling with obesity and mental health issues.

Gender

ALL

Eligibility criteria

• 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.