Trans-cutaneous Vagal Nerve Electrical Stimulation and Irritable Bowel Syndrome (StVSII)

Civil Hospices of Lyon

Status: Completed

Conditions: Irritable Bowel Syndrome

Treatments: Device: Trans-cutaneous vagal nerve electrical stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02420158

2014.844

Details and patient eligibility

About

This pilot study plan to investigate the sympathovagal balance in women affected by Irritable Bowel Syndrome (IBS), and to evaluate the effect of 6 months of trans-cutaneous vagal nerve electrical stimulation on digestive physiology (intestinal transit time, intestinal mucosal permeability, systemic and local inflammation), symptoms and quality of life.

The safety of the electrical stimulation of the left vagal nerve will also be evaluated.

Ten women, age between 18 and 60, will be included.

Enrollment: 18 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• women aged 18-60,
• clinical Rome III criteria for IBS

Exclusion criteria

• pregnancy,
• low intensity symptoms (Francis score between 75-150)
• IBD, coeliac disease
• past history of abdominal surgery (appendectomy and cholecystectomy allowed)
• chronic use of analgesics, anti-depressants

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Vagal nerve stimulation

Experimental group

Description:

Trans-cutaneous vagal nerve electrical stimulation during 6 months

Treatment:

Device: Trans-cutaneous vagal nerve electrical stimulation