Ongoing clinical trials on the treatment of gut–brain axis disorders (based on clinicaltrials.gov).
| Trial ID/Phase/Type of study | Aim of the study | Intervention strategy | Status/Results |
|---|---|---|---|
| NCT03835468Phase: Not ApplicableType: RCT, single-center interventional study | To evaluate the effects of galacto-oligosaccharides (GOS) on the gut–brain axis, focusing on trait anxiety, neurochemistry (GABA/glutamate via 1H-MRS), gut microbiome composition, cognition, and nutritional outcomes in healthy young females. | Galacto-oligosaccharides (prebiotic) vs. placebo | Unknown status, was recruiting patients until 2021, no results posted |
| NCT06117930Type: Observational study | To explore how microorganisms in the gut can affect the growth and progression of the brain tumors using spatial transcriptome/proteomics/multi-omics coupled with microbiome data. | Bioinformatics analysis of multi-omics data from blood, tissue, saliva, urine, and stool samples | Recruiting patients |
| NCT07010445Phase: Not ApplicableMulticenter (Italy) | Microbiota–gut–brain axis in Resistant Epilepsy (CARE): To investigate the role of gut bacteria in drug-resistant epilepsy (DRE), exploring how gut microbiota changes influence seizures and how treatments (surgery, VNS, ketogenic diet) impact these changes. | Longitudinal stool/blood sampling in epilepsy patients | Recruiting patients |
| NCT02849028Phase: Not ApplicableType: Single-center observational study | The clinical research on the relationship between circadian rhythm and gut microbiota in TBI patients: to investigate gut microbiota differences between traumatic brain injury patients with and without sleep disorders. | Observational stool sampling in TBI patients | Status unclear, was recruiting patients till 2016 |
| NCT05628480Phase: Not ApplicableType: Single-center observational study | Multi-omics analyses reveal microbiota–gut–brain axis in ICU patients with post-cardiac surgery delirium: to investigate the microbiota–gut–brain axis mechanisms in postoperative delirium following cardiac surgery. | Multi-omics (stool/blood) in post-cardiac surgery patients | Completed (April 2024), no results posted |
| NCT04788836Phase: Not ApplicableType: Observational study(BrainFood Part 2) | To elucidate the changes in food behavior among obese adults undergoing obesity treatments, with the hypothesis that the altered gut–brain axis influences food choices.To observe the effect of obesity treatments on food purchase behavior using digital receipts from grocery shopping, with the hypothesis that bariatric surgery leads to changes in food purchase behavior in obese adults. | Looking at the digital receipts from grocery shopping to analyze the behavior of the type of food they are purchasing | Active, not recruiting patients |
| NCT04813003Phase: Not ApplicableType: Observational(BrainFood Part 1) | To elucidate the neurobehavioral underpinnings of food behavior among obese adults and how food behavior is altered by different obesity treatments. | Experimental setting combining neurobehavioral tasks, computational modelling, and functional brain imaging (surgery group vs. control group) | Completed, no results posted |
| NCT06020703Phase: Not ApplicableType: Interventional | Effects of diets rich in fermented food on adult mental health: Investigating the impact of fermented food consumption on mental health outcomes through the gut–brain axis. | Fermented food-rich diet | Active, not recruiting |
AB: Conceptualization, Writing—original draft. SS: Conceptualization, Writing—original draft. KH: Writing—original draft. VR: Conceptualization, Writing—original draft, Writing—review & editing, Supervision. All authors read and approved the submitted version.
The authors declare that there are no conflicts of interest.
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