Anxiety and Depression in IBS: A Brain-Gut Axis Study (NCT07646834) | Clinical Trial Compass
RecruitingNot Applicable
Anxiety and Depression in IBS: A Brain-Gut Axis Study
China200 participantsStarted 2025-12-21
Plain-language summary
This study aims to understand how the gut and the brain communicate in people with Irritable Bowel Syndrome (IBS) who also experience anxiety and depression. We want to see if changes in gut bacteria are linked to changes in brain function, and to find potential markers that could help in diagnosis or future treatments.
We are looking for two groups of volunteers aged 18 to 60 years: 1) 100 patients diagnosed with IBS who also have symptoms of anxiety or depression, and 2) 100 healthy volunteers for comparison. All participants must be right-handed.
Participants in this observational study will not receive any new drug or treatment. Instead, they will be asked to:
Complete questionnaires about their bowel symptoms, anxiety, depression, sleep, and thinking skills.
Provide a stool sample (about 5 grams) and a blood sample (about 5 ml).
Undergo a brain scan using a 7 Tesla MRI machine, which will take about 45-50 minutes. They will need to lie still during the scan.
Some IBS patients may be invited for a follow-up visit after 3 months to repeat the questionnaires and sample collection.
There are minimal risks involved. The MRI scan is non-radioactive and considered very safe, but some people may feel uncomfortable or claustrophobic inside the machine. Giving blood may cause brief pain, bruising, or, very rarely, infection. Your privacy is protected. All personal information and data will be coded and kept confidential, and will only be used for this research.
The main benefit to participants is receiving a detailed health assessment, including advanced brain imaging and analysis of gut bacteria, at no cost. There is no direct therapeutic benefit from participating, but the knowledge gained may help improve the understanding and future care of IBS.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Right-handed, aged 18-60 years, with more than 6 years of education;
. Meeting the Rome IV diagnostic criteria for IBS: Symptoms have been present for at least 6 months, and for the last 3 months, the following criteria are met: recurrent abdominal pain or discomfort, with symptoms occurring on at least 3 days per month in the last 3 months, associated with two or more of the following: 1) Improvement with defecation; 2) Onset associated with a change in frequency of stool; 3) Onset associated with a change in form (appearance) of stool;
. The following symptoms support the diagnosis of IBS: 1) Abnormal stool frequency: \<3 bowel movements per week or \>3 bowel movements per day; 2) Abnormal stool form: lumpy/hard stool or mushy/watery stool; 3) Straining during defecation; 4) Urgency or a feeling of incomplete evacuation; 5) Passage of mucus; 6) Bloating.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Alteration in Brain-Gut Axis Functional Connectivity
Timeframe: To assess the change in the severity of irritable bowel syndrome (IBS) symptoms, including abdominal pain, bloating, and bowel habit disturbances, as measured by validated scoring systems (e.g., IBS-SSS) from baseline to the end of the 3-month follow-up
. History of anti-anxiety/depressant medication use (e.g., SSRI/SNRI, Chinese patent medicines) within the past 1 month;
. History of antibiotic or probiotic use within the past 1 month;
. Other gastrointestinal diseases such as IBD, intestinal obstruction, or history of gastrointestinal surgery;
. Current or past history of psychiatric or neurological disorders, such as psychosis, brain tumors, or impaired consciousness;
. Concurrent severe hepatic or renal insufficiency, cardiovascular or cerebrovascular diseases, or malignant tumors; 7.0T MRI Contraindications: Presence of ferromagnetic implants (e.g., cardiac pacemakers, defibrillators, neurostimulators, aneurysm clips, cochlear implants, or any metallic foreign bodies); Non-ferromagnetic implants (e.g., titanium alloy, orthopedic implants), various types of intrauterine devices, various types of non-removable dentures (including dental implants); Presence of metallic foreign bodies (e.g., metal fragments, shrapnel, or filings in the eyes or body), such as in individuals engaged in welding work or with a history of metal item trauma; Tattoos or permanent makeup (e.g., eyebrows, lips) applied within the past month; Claustrophobia; Fever.
. Right-handed, aged 18-60 years, with more than 6 years of education;
. All physiological indicators are within normal ranges, with no signs of disease;
. No family history of psychiatric or neurological disorders.