Neural Circuit Mechanism of Inflammatory Bowel Disease Combined With Depression

NCT06471894 | Not Yet Recruiting

• 1 other identifier: 2024A-255
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (2)

• Magnetic resonance spectroscopy

  Changes in GABA content in the prefrontal lobe of the brain

  1 week before and 1 week after FMT

• Magnetic resonance spectroscopy

  Changes in alpha diversity and differential abundance of gut microbiota

  1 week before and 1 week after FMT

Study Arms (3)

CD

Crohn's disease

Radiation: Magnetic resonance imaging scanning; Drug: FMT Protocol

UC

ulcerative colitis

Radiation: Magnetic resonance imaging scanning; Drug: FMT Protocol

HC

healthy controls

Radiation: Magnetic resonance imaging scanning

Interventions

Magnetic resonance imaging scanning RADIATION

Perform brain diffusion imaging, magnetic resonance spectroscopy, and functional magnetic resonance imaging scans on all individuals

CD; HC; UC

FMT Protocol DRUG

Treatment of disease groups (UC and CD) using prepared fecal microbiota transplantation solution

CD; UC

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The inflammatory bowel disease (IBD) combined with depression have increased psychological stress. Individuals with IBD often face prolonged physical discomfort and treatment challenges, which can lead to increased emotional burden and susceptibility to depression. IBD is a chronic condition requiring long-term management and treatment. These ongoing lifestyle changes and medical burdens may contribute to feelings of sadness and depression. In summary, depression is common among individuals with inflammatory bowel disease. It is important to monitor the mental health of patients during treatment and provide proactive psychological support and intervention when needed.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• LanZhou University: lead

Biospecimen

Retention: SAMPLES WITH DNA

Fecal collection

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

FMT protocol

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Jun Wang, Doctor

  The Second Hospital & Clinical Medical School, Lanzhou University

  STUDY CHAIR

Central Study Contacts

Jun Wang, Doctor

CONTACT

+8618298366202; wangj20@lzu.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 18, 2024
• First Posted: June 24, 2024
• Study Start: July 1, 2024
• Primary Completion: July 1, 2024
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 25, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Around December 31, 2026
• Access Criteria: Email the corresponding author with reasonable reasons for inquiry