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The influence of bifidobacteria on the brain fMRI characteristics of patients with irritable bowel syndrome: a single-center, double-blind, placebo randomized controlled trial

The influence of bifidobacteria on the brain fMRI characteristics of patients with irritable bowel syndrome: a single-center, double-blind, placebo randomized controlled trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200055173
Enrollment
Unknown
Registered
2022-01-02
Start date
2022-01-10
Completion date
Unknown
Last updated
2023-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable bowel syndrome (IBS)

Interventions

Experimental group:Bifidobacterium quadruple viable tablet
Control group:Placebo

Sponsors

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Adult patients aged 18 years and older and less than 65 years old diagnosed with IBS (Rome III criteria); 2. Have undergone colonoscopy in a tertiary hospital within 2 years before screening, and keep the inspection report; 3. Those who can understand and accept the research program and voluntarily sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Additional MRI-related exclusion criteria include claustrophobia and ferromagnetic implants; 2. Patients with cardiac pacemakers or implantable cardiac pacemakers or other implanted electronic medical devices; 3. Those who are pregnant or who cannot be used for effective contraception during the research period; 4. Long-term use of immunosuppressants, glucocorticoids, opioids, antidepressants or anxiolytics; or alcohol or illegal drugs and other drugs that may affect the study; 5. Other diseases that can cause changes in brain magnetic resonance such as cerebral hemorrhage and cerebral infarction; 6. Those who have been diagnosed with organic diseases of the digestive system in the past, such as inflammatory bowel disease, intestinal tuberculosis, intestinal polyps (polyps < 0.5cm can still be added), intestinal diverticulum, intestinal tumor, etc. or currently combined with peptic ulcer, infectious diarrhea, etc.; 7. Hyperthyroidism, diabetes, myasthenia gravis and other systemic diseases that may affect the function of the gastrointestinal tract; 8. Previously diagnosed with diseases similar to irritable bowel syndrome symptoms, such as eosinophilic enteritis, microscopic colitis (including collagenous colitis and lymphocytic colitis), lactose intolerance, malabsorption syndrome, etc.; 9. History of previous digestive system surgery (except appendectomy and intestinal polypectomy 7), such as cholecystectomy; 10. Severe mental illness or language barrier, unable to fully understand this research and sign the informed consent; 11. The researcher believes that there are other circumstances that are not suitable for this study.

Design outcomes

Primary

MeasureTime frame
Functional magnetic resonance imaging of the brain;Serum cortisol;Corticotropin;Fecal microbiome and metabolome;

Countries

China

Contacts

Public ContactHou Xiaohua

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

houxh@hust.edu.cn+86 27 85726057

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026