Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2026-02-01 @ 8:31 PM
Study NCT ID:
NCT06471894
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neural Circuit Mechanism of Inflammatory Bowel Disease Combined With Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C053075', 'term': 'FMT protocol'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Fecal collection'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2027-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-23', 'studyFirstSubmitDate': '2024-06-18', 'studyFirstSubmitQcDate': '2024-06-18', 'lastUpdatePostDateStruct': {'date': '2024-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Magnetic resonance spectroscopy', 'timeFrame': '1 week before and 1 week after FMT', 'description': 'Changes in GABA content in the prefrontal lobe of the brain'}, {'measure': 'Magnetic resonance spectroscopy', 'timeFrame': '1 week before and 1 week after FMT', 'description': 'Changes in alpha diversity and differential abundance of gut microbiota'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Inflammatory Bowel Diseases']}, 'descriptionModule': {'briefSummary': '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:\n\nDoes fecal microbiota transplantation (FMT) improve depression symptoms in IBD patients by altering GABA levels in the medial prefrontal cortex?\n\nParticipants 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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\naged 18-65 years right-handed active disease (CDAI score ≥150, Mayo score \\>2).\n\nExclusion Criteria:\n\nprevious brain surgery those with severe and unstable physical diseases those with contraindications for MRI who cannot tolerate long-duration MRI examinations.'}, 'identificationModule': {'nctId': 'NCT06471894', 'acronym': 'NCMOIBDCWD', 'briefTitle': 'Neural Circuit Mechanism of Inflammatory Bowel Disease Combined With Depression', 'organization': {'class': 'OTHER', 'fullName': 'LanZhou University'}, 'officialTitle': 'Study on the Neural Circuit Mechanism of Regulating GABA by Gut Microbiota in Inflammatory Bowel Disease Combined With Depression', 'orgStudyIdInfo': {'id': '2024A-255'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CD', 'description': "Crohn's disease", 'interventionNames': ['Radiation: Magnetic resonance imaging scanning', 'Drug: FMT Protocol']}, {'label': 'UC', 'description': 'ulcerative colitis', 'interventionNames': ['Radiation: Magnetic resonance imaging scanning', 'Drug: FMT Protocol']}, {'label': 'HC', 'description': 'healthy controls', 'interventionNames': ['Radiation: Magnetic resonance imaging scanning']}], 'interventions': [{'name': 'Magnetic resonance imaging scanning', 'type': 'RADIATION', 'description': 'Perform brain diffusion imaging, magnetic resonance spectroscopy, and functional magnetic resonance imaging scans on all individuals', 'armGroupLabels': ['CD', 'HC', 'UC']}, {'name': 'FMT Protocol', 'type': 'DRUG', 'description': 'Treatment of disease groups (UC and CD) using prepared fecal microbiota transplantation solution', 'armGroupLabels': ['CD', 'UC']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jun Wang, Doctor', 'role': 'CONTACT', 'email': 'wangj20@lzu.edu.cn', 'phone': '+8618298366202'}], 'overallOfficials': [{'name': 'Jun Wang, Doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'The Second Hospital & Clinical Medical School, Lanzhou University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Around December 31, 2026', 'ipdSharing': 'YES', 'description': 'After the data collection is completed, the collected gut microbiota data will be shared', 'accessCriteria': 'Email the corresponding author with reasonable reasons for inquiry'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LanZhou University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jun Wang', 'investigatorAffiliation': 'LanZhou University'}}}}