Transcutaneous Electrical Acustimulation in the Treatment of Mild to Moderate Ulcerative Colitis

Not Applicable

Recruiting

• Conditions: Ulcerative Colitis
• Interventions: Device: transcutaneous electrical acustimulation at sham sites; Device: transcutaneous electrical acustimulation at treatment sites

• Registration Number: NCT06231264
• Lead Sponsor: Xijing Hospital

Brief Summary

The aim of this study was to evaluate the efficacy and safety of transcutaneous electrical acustimulation in patients with mild to moderate ulcerative colitis.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-10
• Study Start: 2024-01-19
• Study First Submitted QC: 2024-01-19
• Study First Posted: 2024-01-30
• Last Update Submitted: 2024-10-09
• Last Update Posted: 2024-10-14
• Primary Completion: 2025-01-01
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

1. Age ≥18 years
2. Ulcerative colitis diagnosed for at least 3 mouths.
3. Mayo score 4-10, Mayo endoscopic score 2-3 points
4. Resistant to at least one type of medical treatments

Exclusion Criteria

1. Treatment-naive ulcerative colitis (no previous treatment)
2. Acute severe ulcerative colitis
3. Previous surgical treatment or severe colitis at imminent risk of surgery infective colitis
4. Other systemic diseases
5. Pregnancy and lactation
6. Allergic to the electrode patch

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
shame group	transcutaneous electrical acustimulation at sham sites	Subjects will be trained to use the devices at the sham sites and receive sham treatment twice a day for 8 weeks.
treatment group	transcutaneous electrical acustimulation at treatment sites	Subjects will be trained to use the devices at the treatment sites and receive treatment twice a day for 8 weeks.

Primary Outcome Measures

Name	Time	Method
Clinical response	8 weeks	decrease of ≥3 points and ≥30% from baseline mayo score and decrease of ≥1 point in rectal bleeding subscore or absolute rectal bleeding subscore ≤ 1

Secondary Outcome Measures

Name	Time	Method
C reactive protein	4 and 8 weeks	blood sample
pancreatic polypeptide	4 and 8 weeks	blood sample
Endoscopic remission	8 weeks	defined as Mayo endoscopic score ≤ 1
Fecal calprotectin	4 and 8 weeks	fecal sample
Change from baseline in the Mayo score	8 weeks	Mayo score at 8 week minus the Mayo score at baseline. The range of Mayo score is 0-12, and higher scores mean worse outcome.
norepinephrine	4 and 8 weeks	blood sample
Hospital Anxiety and Depression scale score	4 and 8 weeks	anxious depression. The range of Hospital Anxiety and Depression scale score is 0-21, and higher scores mean worse outcome.
Clinical remission	8 weeks	overall score ≤2 \[and no individual subscore \>1\]
erythrocyte sedimentation rate	4 and 8 weeks	blood sample
Symptomatic remission	2, 4, 6, and 8 weeks	Stool frequence subscore = 0 (or = 1 with a ≥ 1-point decrease from baseline) and rectal bleeding subscore = 0
acetyl choline	8 weeks	Intestinal mucosal tissue sample
Inflammatory Bowel Disease Questionnaire Score	4 and 8 weeks	The range of Inflammatory Bowel Disease Questionnaire Score is 32-224, and higher scores mean worse outcome
Pittsburgh sleep quality index	4 and 8 weeks	The range of Pittsburgh sleep quality index is 0-21, and higher scores mean worse outcome.
alpha7 nicotinic acetylcholine receptor	8 weeks	Intestinal mucosal tissue sample
autonomic profile characteristics	4 and 8 weeks	heart rate variability indicating sympathetic and parasympathetic activity

Trial Locations

Locations (4)

Honghui hospital; 🇨🇳 Xi'an, Shaanxi, China

Second Affiliated Hospital of Xi 'an Jiaotong University; 🇨🇳 Xi'an, Shaanxi, China

Tangdu Hospital; 🇨🇳 Xi'an, Shaanxi, China

Xijing Hospital; 🇨🇳 Xi'an, Shaanxi, China