Gut–brain gut study in IBS with anxiety and depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study enrolls 200 adults aged 18-60, with 100 IBS patients who have anxiety or depression and 100 healthy controls, all right-handed. Participants provide stool and blood samples, complete questionnaires on bowel symptoms and mental health, and undergo a 7 Tesla MRI brain scan lasting about 45-50 minutes. The goal is to explore connections between gut microbiota and brain activity and to identify potential markers for diagnosis or future therapies. No new treatments are administered during the study. Inclusion requires Rome IV-confirmed IBS with specific symptom criteria and no prior use of anti-anxiety or antidepressant medications.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Right-handed, aged 18-60 years, with more than 6 years of education;
2. 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;
3. 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:

1. History of anti-anxiety/depressant medication use (e.g., SSRI/SNRI, Chinese patent medicines) within the past 1 month;
2. History of antibiotic or probiotic use within the past 1 month;
3. Other gastrointestinal diseases such as IBD, intestinal obstruction, or history of gastrointestinal surgery;
4. Current or past history of psychiatric or neurological disorders, such as psychosis, brain tumors, or impaired consciousness;
5. 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.

HC Group Inclusion Criteria (all must be met):

1. Right-handed, aged 18-60 years, with more than 6 years of education;
2. All physiological indicators are within normal ranges, with no signs of disease;
3. No family history of psychiatric or neurological disorders.

Where it's running

• Tangdu Hospital, Air Force Medical University
  Xi'an, Shaanxi, China Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Mindful Smartphone Use: A Mindfulness-Based Program for Teens with Sleep and Mood Challenges

  This study tests Mindwire, a mindfulness-based program, to see if it helps teens with problematic phone use who also have depression or anxiety.

  Recruiting Brown University · Providence, Rhode Island · NCT07892807

• Tele-based wellbeing centres for women's mental health in Bangladesh

  A randomized trial tests whether tele-counselling for depression and anxiety in Bangladeshi women is as effective as in-person counselling.

  Recruiting at 2 sites International Centre for Diarrhoeal Disease Research, Bangladesh · Chāndpur, Matlab Dakshin and 1 other locations · NCT07890896

• HBOT to see if it helps cognition and well‑being in first responders with prior brain injury

  This study tests whether 40 hyperbaric oxygen therapy sessions can improve thinking skills and post-concussion symptoms in current or former first responders with a history of brain injury.

  Recruiting Phase 2 Summit Hyperbarics and Wellness · Boise, Idaho · NCT07852728

• Focused ultrasound for mood and anxiety disorders

  This study tests whether repeated low-intensity focused ultrasound using the ATTN201 device can help people with subsyndromal to moderate depression, anxiety, or OCD.

  Recruiting Attune Neurosciences Inc · San Francisco, California and 1 other locations · NCT07851038

• An Ultra-Brief ICBT Intervention with Personal Feedback for Depression and Anxiety

  This trial tests whether adding personalized feedback about a person’s recent healthy actions to the Things You Do ultra-brief online CBT program helps adults with depression and anxiety do more healthy activities and feel better.

  Recruiting University of Regina · Regina, Saskatchewan · NCT07806864

• Virtual nature vs guided imagery for anxiety and well-being in hospitalized older adults

  In this study, hospitalized adults 65 and older try two ways to bring nature to them: watching 360-degree nature videos on a VR headset or listening to a guided imagery audio to imagine the same scenes, to see which helps mood and anxiety during a two-week period.

  Recruiting at 2 sites Semmelweis University · Budapest and 1 other locations · NCT07765355

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.