Testing a gut bacteria supplement for binge eating and obesity in adults
Tests a daily probiotic supplement against a placebo in adults with binge eating.
Plain-language title generated from the registry record
Registry title: Investigation of the Mechanisms of the Gut-brain Axis in Binge Eating and Obesity.
Key facts
- Where
- Porto, PortugalSee the site
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 20 and 45 years old?
Source: NCT06823557, who can take part
Where in Portugal
- Center for Psychology at University of PortoPorto, PortugalNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Universidade do Porto
- Trial code
- NCT06823557
- Record updated
- 28 March 2025
- Original description
Binge Eating Disorder (BED) is a recently recognized eating disorder, characterized by recurrent episodes of overeating with a loss of control. Highly comorbid with obesity, BED is associated with poor outcomes in weight loss treatments and presents unique challenges due to its distinct neuro-psycho-biological mechanisms, which remain poorly understood. The Microbiota-Gut-Brain Axis (MGBA) is a bidirectional communication system linking the gut microbiota with the central nervous system, that plays a critical role in regulating appetite, mood, and eating behavior. Dysregulations in MGBA may contribute to the development and maintenance of BED, offering a novel framework for understanding its complex mechanisms and identifying new therapeutic targets. Psychobiotics -pre-, pro-, or symbiotics that modulate the microbiota- emerge as a promising treatment strategy to address BED symptoms by influencing MGBA activity.Read full original descriptionShow less
Gut2Brain: Investigation of the Mechanisms of the Gut-brain Axis in Binge Eating and Obesity
Binge Eating Disorder (BED) is a recently recognized eating disorder, characterized by recurrent episodes of overeating with a loss of control. Highly comorbid with obesity, BED is associated with poor outcomes in weight loss treatments and presents unique challenges due to its distinct neuro-psycho-biological mechanisms, which remain poorly understood. The Microbiota-Gut-Brain Axis (MGBA) is a bidirectional communication system linking the gut microbiota with the central nervous system, that plays a critical role in regulating appetite, mood, and eating behavior. Dysregulations in MGBA may contribute to the development and maintenance of BED, offering a novel framework for understanding its complex mechanisms and identifying new therapeutic targets. Psychobiotics -pre-, pro-, or symbiotics that modulate the microbiota- emerge as a promising treatment strategy to address BED symptoms by influencing MGBA activity.
The goal of this randomized clinical trial (RCT) is to investigate the role of psychobiotics in modulating the gut-brain axis and improving binge eating in adults, with a particular focus on evaluating these effects independently of obesity status. This project stands out for its comprehensive approach to understanding BED, integrating psychological, neurofunctional, hormonal, and microbiota factors that contribute to this complex disorder.
The main questions it aims to answer are:
* What specific alterations in the MGBA pathways are associated with BED? * Can psychobiotic supplementation effectively reverse microbiota alterations and modulate MGBA activity, ultimately improving BED symptoms? Researchers will compare participants receiving psychobiotics to those receiving a look-alike substance that contains no drug (a placebo) to evaluate whether psychobiotics impact endocrine hormones, neurofunction, psychological and behavioral factors related to eating regulation, and BED symptoms.
Participants will:
* Undergo an assessment protocol that includes microbiota sampling, blood tests for hormone analysis, neurofunctional evaluations, and psychological/behavioral assessments before and after the psychobiotics/ placebo intervention. * Take psychobiotics or a placebo daily for 12 weeks and receive well-being monitoring * Participate in follow-up visits three months after the intervention to monitor changes in BED symptoms and related parameters.
Inclusion: Portuguese adults (25 with normal weight; 25 with obesity only (30 ≤ BMI < 40) and BED; 54 with BED); Residents in Portugal for the past 10 years.
Exclusion: Use of medications that impact weight; Have metal implants or pacemakers; History of surgery or medical/psychiatric diseases; History of drug use or dependence; Significant weight loss (>5% of body weight) in the past 2 years; Antibiotic use in the past 6 months; Pregnant or breastfeeding.