Trans-cutaneous Vagal Nerve Electrical Stimulation and Irritable Bowel Syndrome

Not Applicable

Completed

• Conditions: Irritable Bowel Syndrome
• Interventions: Device: Trans-cutaneous vagal nerve electrical stimulation

• Registration Number: NCT02420158
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-04-14
• Study First Submitted QC: 2015-04-16
• Study First Posted: 2015-04-17
• Study Start: 2015-05
• Primary Completion: 2018-08
• Study Completion: 2018-08
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-03
• Last Update Posted: 2019-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 18

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vagal nerve stimulation	Trans-cutaneous vagal nerve electrical stimulation	Trans-cutaneous vagal nerve electrical stimulation during 6 months

Primary Outcome Measures

Name	Time	Method
Improvement of clinical symptoms of IBS, based on the evolution of symptom score (Francis) and symptom scale (UCLA-SSS)	3 and 6 months after the beginning of electrical stimulation

Secondary Outcome Measures

Name	Time	Method
Effect of vagal nerve stimulation on quality of life	3 and 6 months	Quality of life and psychological questionnaires
Evaluation of sympatho-vagal balance	0, 3 and 6 months	Measurement by nocturnal EKG Holter of the variability of the interval RR, as a marker of the sympatho-vagal balance
Safety and tolerance of trans-cutaneous nerve stimulation as measured by any symptom occurring in relation with electrical stimulation, number of hours per day of system use	6 months	Any symptom occurring in relation with electrical stimulation, number of hours per day of system use
Evolution of digestive physiology during vagal nerve stimulation	3 and 6 months	Digestive physiology is evaluated by intestinal transit time with Smartpill capsule, lactuose/mannitol intestinal permeability test, fecal calprotectin and blood cytokines

Trial Locations

Locations (2)

Service d'Exploration Fonctionnelle Digestive - Hôpital Edouard Herriot - Hospices Civils de Lyon; 🇫🇷 LYON Cedex 03, France

Clinique Universitaire d'Hépato-Gastroentérologie - CHU de Grenoble; 🇫🇷 Grenoble, France