Overview

This trial is active, not recruiting.

Condition active ulcerative colitis
Treatment interstim ii neurostimulator model 3058
Sponsor Nantes University Hospital
Start date June 2016
End date March 2018
Trial size 12 participants
Trial identifier NCT02748590, RC15_0448

Summary

Efficacy of ulcerative colitis to induce remission in patients with moderate to severe active ulcerative colitis.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
interstim ii neurostimulator model 3058
The neuromodulation will be carried out according to the usual protocol: Hospitalization for the establishment of percutaneous electrode in the operating room under general anesthesia with fluoroscopic control. The pacemaker startup will be performed within 12h after surgery

Primary Outcomes

Measure
Efficacy of neuromodulation to induce remission at Week 8 in patients with moderate to severe active ulcerative colitis (Mayo score)
time frame: 8 weeks

Secondary Outcomes

Measure
Assess the Remission at Week 16 ( Mayo score)
time frame: 16 weeks
Assess the Response at Week 8 and Week 16 (scale Ulcerative Colitis Disease Activity Index)
time frame: 16 weeks
Assess the clinical response at Week 8 and Week 16 (scale Ulcerative Colitis Disease Activity Index)
time frame: 16 weeks
Assess the endoscopic response at Week 8 and Week 16 (scale Ulcerative Colitis Disease Activity Index)
time frame: 16 weeks
Assess the histological response at Week 8 and Week 16 (Geboes Score)
time frame: 16 weeks
Assess the biological response at Week 8 and Week 16 (C-reactive protein)
time frame: 16 weeks
Assess the biological response at Week 8 and Week 16 (Calprotectin)
time frame: 16 weeks
Evaluate the symptom's resolution at Week 3, Week 8 and Week 16 (scale Ulcerative Colitis Disease Activity Index)
time frame: 16 weeks
Evaluate the urgencies cessation at Week 3, Week 8 and Week 16 (scale Ulcerative Colitis Disease Activity Index)
time frame: 16 weeks
Evaluate the cessation of rectal bleeding at Week 8, Week 16
time frame: 16 weeks
Evaluate the immunosuppressive drugs at Week 8 and Week 16
time frame: 16 weeks
Evaluate the need for steroids at Week 8 and Week 16
time frame: 16 weeks
Evaluate the tolerance of neuromodulation in Ulcerative Colitis patients at Week 3, Week 8 and Week 16
time frame: 16 weeks
Evaluate the quality of life of the patients at Week 8 and Week 16 (Scale The Short Form 36)
time frame: 16 weeks
Assess abdominal discomfort for weeks at Week 8 and Week 16
time frame: 16 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Active Ulcerative Colitis diagnosed on criteria Lennard Jones (31) for at least 1 year - > 18 yo - E1 - E2 disease or extended to transverse colon but not beyond the hepatic flexure (endoscopic pictures) - resistant to medical treatment: active after introduction for at least 8 weeks of maintenance treatment (immunosuppressive or anti-TNF) - Activity score >5 and endoscopic score >2 - Absence of bacterial infection in progress (Clostridium difficile) - Affiliated with a social protection scheme and had signed an informed consent Exclusion Criteria: - Severe forms requiring hospitalization an intravenous treatment or immediate surgery - infectious colitis or proctitis - Prednisone> 20 mg / d - Contraindications to the use of neuromodulator - Corticosteroid therapy by intravenous route - Pregnant women - Major Trust

Additional Information

Official title Evaluation of Sacral Neuromodulation (SNM) in the Treatment of Active Ulcerative Colitis
Description Neuromodulation is a validated option for the treatment of fecal incontinence. Safety of this original approach has been confirmed by several studies. New indications for this minimally-invasive procedure are actually under evaluation particularly in the fields of irritable bowel syndrome and chronic constipation with promising results. Its mechanism of action remains partially unknown and the target of neuromodulation is not limited to the anal sphincter but the whole colonic motility seems to be influenced by this therapeutic approach. Moreover, recent experimental studies have shown that neuromodulation was able to reinforce the intestinal epithelial barrier involved in the pathophysiology of ulcerative colitis. Subsequently, preliminary results in human have shown improvement of inflammation in patients suffering from inflammatory bowel diseases. In fact, despite recent improvement in medical therapies in inflammatory bowel diseases and particularly in ulcerative colitis, several patients are suffering from disabling chronic active disease. In those cases of refractory diseases, the only alternative treatment is a pan-proctocolectomy and ileal pouch surgery. This approach is a curative option, but leads to a significant morbidity and frequent functional disorders in the long-term follow-up (permanent stoma in 7 to 10% of the cases). Moreover, in limited distal disease (left colon and rectum) the surgical option seems to be unadapted and many patients remain symptomatic and suffer chronic active disease. The aim of this study will be to assess in a prospective pilot study the efficacy of ulcerative colitis in inducing the remission of chronic active ulcerative colitis limited to the left side of the colon and improving the quality of life of the patients.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Nantes University Hospital.