Trans-cutaneous Vagal Nerve Electrical Stimulation and Irritable Bowel Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2018-08-31

Brief Summary

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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.

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Healthy Volunteer

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Detailed Description

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Conditions

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Irritable Bowel Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vagal nerve stimulation

Trans-cutaneous vagal nerve electrical stimulation during 6 months

Group Type EXPERIMENTAL

Trans-cutaneous vagal nerve electrical stimulation

Intervention Type DEVICE

Interventions

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Trans-cutaneous vagal nerve electrical stimulation

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No