Synbiotic supplement to improve mood and gut health in adults with obesity
Official title: New Dietary Intervention Strategies on the Intestinal Microbiota to Improve Mental Health Subjects With Obesity: Therapeutic Potential of a Synbiotic.
Run by Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana · NCT06901739 · Data updated 2026-11-12
This study will test whether taking a daily synbiotic (prebiotics plus beneficial bacteria) helps mood, gut microbiota, inflammation, appetite, and metabolic markers in adults with obesity who do or do not have anxiety or depression.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana Academic / other |
| Locations | 1 site (Valencia, Valencia) |
| Status | Recruiting |
| Started | April 15, 2025 |
| Main results expected | April 30, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | September 8, 2026 |
| Trial ID | NCT06901739 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–65 years old with BMI 30–40 kg/m2, at least five years since obesity diagnosis, stable weight for the prior three months, and without excluded medical or psychiatric conditions are the intended participants.
✕Probably not a fit
People with active inflammatory or neoplastic disease, uncontrolled secondary causes of obesity, significant liver or kidney failure, recent antibiotic use, psychiatric disorders beyond anxiety/depression, current antidepressant use, pregnancy, lactation, or prior bariatric surgery were excluded and are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, randomized, double-blind, placebo-controlled intervention enrolling 120 adults with BMI 30–40 kg/m2 (age 18–65). Participants will be randomly assigned (60 per group) to receive either a synbiotic supplement or a matched placebo. The trial will measure changes in gut microbiota composition and function, neurotransmitter production related to the gut–brain axis, inflammatory and metabolic biomarkers, intestinal function, appetite control, mood, and quality of life. Key exclusions include acute or chronic inflammatory or neoplastic disease, significant liver or kidney failure, recent antibiotic use, psychiatric disorders other than anxiety/depression, current antidepressant therapy, pregnancy, lactation, or prior bariatric surgery.
Why it matters
Potential benefit: If successful, the synbiotic could provide a low-risk adjunct treatment to improve mood, gut bacterial balance, inflammation, and metabolic health in people with obesity.
How similar studies have gone: Previous small trials of probiotics and synbiotics have produced mixed but sometimes promising effects on mood and metabolic outcomes, so this approach has preliminary support but is not yet definitive.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Fisabio
Valencia, Valencia, Spain Recruiting
Study contacts
- Study coordinator: Celia Bañuls Morant, PhD
- Email: celia.banuls@fisabio.es
- Phone: 963188882
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.