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Transcutaneous Auricular Vagus Nerve Stimulation for Liver Qi Stagnation and Spleen Deficiency Type Irritable Bowel Syndrome: Efficacy and Mechanism Exploration of Brain-Gut-Microbiota Axis

Transcutaneous Auricular Vagus Nerve Stimulation for Liver Qi Stagnation and Spleen Deficiency Type Irritable Bowel Syndrome: Efficacy and Mechanism Exploration of Brain-Gut-Microbiota Axis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026001350
Enrollment
Unknown
Registered
2026-05-26
Start date
2026-01-09
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Diarrhea-predominant Irritable Bowel Syndrome

Interventions

Experimental group:Electro-neurostimulation therapy on the distribution area of the auricular branch of the vagus nerve
Control Group:Electro-neurostimulation therapy in the non-vagal nerve distribution area

Sponsors

Jiangsu Province Integrated Chinese and Western Medicine Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1) Sign a written informed consent to participate in the trial; 2) Be male or female, at least 18 years old or older and under 70 years old on the day of signing the informed consent; 3) Be patients who meet both the Western diagnostic criteria for IBS-D and the Chinese medicine symptom diagnostic criteria.

Exclusion criteria

Exclusion criteria: 1) Those with heart, brain, liver, kidney, hematopoietic system diseases, or other severe conditions significantly affecting survival; 2) Individuals with mental health disorders; 3) Those diagnosed with organic lesions via digestive endoscopy, or with a history of abdominal surgery; 4) Patients with endocrine diseases, such as diabetes or hyperthyroidism, that may impact gastrointestinal motility; 5) Women who are planning to conceive, are pregnant, or are breastfeeding; 6) Individuals with severe skin damage in the earlobe area or those with absent earlobes; 7) Those with claustrophobia, implanted metallic devices, or other conditions preventing MRI scans.

Design outcomes

Primary

MeasureTime frame
IBS symptom severity scale;Visual Analogue Scale;Heart Rate Variability;functional magnetic resonance imaging;Brain-gut peptide;inflammatory biomarkers;gut microbiota;

Secondary

MeasureTime frame
Hamilton Anxiety Rating Scale;Hamilton Depression Rating Scale;Irritable Bowel Syndrome Quality of Life Scale;Pittsburgh Sleep Quality Index Scale;

Countries

China

Contacts

Public ContactLi Hui

Jiangsu Province Integrated Chinese and Western Medicine Hospital

32260890@qq.com17601558686

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Jun 11, 2026