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Gut-Brain connection in IBS: scientists hunt for clues to anxiety and depression

NCT ID NCT07646834

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study investigates how the gut and brain communicate in people with Irritable Bowel Syndrome (IBS) who also experience anxiety or depression. Researchers will compare 100 IBS patients with anxiety or depression to 100 healthy volunteers using brain scans, stool samples, and blood tests. No treatments are given; the goal is to find biological markers that could improve diagnosis and future care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could identify biological markers that help diagnose or guide future treatments for IBS with anxiety and depression.
What could go wrong
This is an observational study, not a treatment trial. It may not lead directly to new therapies, and results may not apply to all IBS patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adults (18-60 years) with irritable bowel syndrome (IBS) meeting Rome IV criteria and healthy right-handed volunteers, all with at least 6 years of education.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Tangdu Hospital, Air Force Medical University

    RECRUITING

    Xi'an, Shaanxi, 710038, China

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