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Not yet recruiting NCT06471894

Neural Circuit Mechanism of Inflammatory Bowel Disease Combined With Depression

Observational Inflammatory Bowel Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Magnetic resonance imaging scanning, FMT Protocol.
Who it may be relevant to
Registry conditions: Inflammatory Bowel Diseases. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Study on the Neural Circuit Mechanism of Regulating GABA by Gut Microbiota in Inflammatory Bowel Disease Combined With Depression

Overview

The goal of this observational study is to understand the effects of gut microbiota dysbiosis treatment in patients with inflammatory bowel disease (IBD) combined with depression. The main question it aims to answer is: Does fecal microbiota transplantation (FMT) improve depression symptoms in IBD patients by altering GABA levels in the medial prefrontal cortex? Participants already undergoing fecal microbiota transplantation (FMT) as part of their regular medical care for IBD and comorbid depression will undergo regular assessments of GABA levels, gut microbiota, and depression symptoms for the duration of the study.

Detailed description

The high incidence of inflammatory bowel disease (IBD) combined with depression increases the risk of disease recurrence and treatment failure. Previous research by our team has found a positive correlation between decreased levels of the inhibitory neurotransmitter γ-aminobutyric acid (GABA) in the medial prefrontal cortex of IBD patients and the severity of depression. However, the underlying pathological mechanisms remain unknown. Prior studies have suggested that GABA regulates activity within neural circuits in the brain, and the levels of GABA in the brain are influenced by the gut microbiota. Based on this premise, our study aims to treat gut microbiota dysbiosis in IBD patients with comorbid depression using fecal microbiota transplantation (FMT). Our team will analyze the correlation between changes in GABA levels in the medial prefrontal cortex and gut microbiota using techniques such as metagenomics, metabolomics, and magnetic resonance spectroscopy imaging. Additionally, resting-state functional magnetic resonance imaging (fMRI) is used to perform dynamic causal modeling of the neural circuit in the brain to elucidate the regulatory mechanism of GABA level changes on these circuits. Finally, the investigators will validate the research findings using a dextran sulfate sodium (DSS)-induced colitis mouse model to explore the neurochemical mechanisms underlying IBD comorbid with depression. The results of this study will not only provide a deeper understanding of the regulatory role of changes in brain GABA levels on neural circuits but also offer a theoretical basis for the use of fecal microbiota transplantation in treating gut microbiota dysbiosis in IBD patients and prevent complications such as depression.

Interventions

  • Radiation Magnetic resonance imaging scanning
    Perform brain diffusion imaging, magnetic resonance spectroscopy, and functional magnetic resonance imaging scans on all individuals
  • Drug FMT Protocol
    Treatment of disease groups (UC and CD) using prepared fecal microbiota transplantation solution

Primary outcome measures

  • Magnetic resonance spectroscopy [Time frame: 1 week before and 1 week after FMT]
  • Magnetic resonance spectroscopy [Time frame: 1 week before and 1 week after FMT]

Eligibility criteria

Inclusion criteria

aged 18-65 years right-handed active disease (CDAI score ≥150, Mayo score >2).

Exclusion criteria

previous brain surgery those with severe and unstable physical diseases those with contraindications for MRI who cannot tolerate long-duration MRI examinations.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06471894 · 2024A-255

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗