Moxibustion for Diarrhea-predominant Irritable Bowel Syndrome

Study Overview
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Brief Summary
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To observe the safety and efficacy of moxibustion on diarrhea-predominant irritable bowel syndrome and evaluation by Magnetic Resonance Imaging (MRI), Event related potential (ERP).

Detailed Description
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A randomized controlled trial Moxibustion treatment, sham control To observe the safety and efficacy of moxibustion treatment versus placebo control Evaluation by intestinal microbial structural and diversity changes using 16S rDNA sequencing Evaluation by structural MRI and resting state-functional MRI Evaluation by ERP

Official Title
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Study on the Mechanism of Moxibustion Effect on Treating Diarrhea-predominant Irritable Bowel Syndrome

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Device: moxibustion
* Device: Sham moxibustion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diarrhea-predominant IBS patients who met the Rome III diagnostic criteria; Age 18-65 years old, male or female; Volunteered for the trial, signed the informed consent Exclusion Criteria: Intestinal organic disease; Constipation-predominant IBS; Alternating diarrhea and constipation IBS; Unstructured IBS; At the same time, application of smecta, dicetel, cisapride or traditional Chinese medicine; Combined liver, kidney, heart or mental disease patients; Pregnant or lactating women.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Moxibustion group<br>Receiving moxibustion treatment | Device: moxibustion<br>* Acupoints: Tianshu (ST25，bilateral), Zusanli (ST36，bilateral). using mild-warm moxibustion，the surface temperature of acupoints were maintained at 43 ℃ ± 1 ℃, 30min for each acupoint, once every other day, three times a week, a total of six weeks treatment. After the treatment, subjects were followed up at weeks 12, 18 and 24.<br>|
| Sham Comparator: Sham moxibustion group<br>Receiving sham moxibustion. | Device: Sham moxibustion<br>* Acupoints: Tianshu (ST25，bilateral), Zusanli (ST36，bilateral); using sham mild-warm moxibustion，the surface temperature of acupoints were maintained at 37 ℃ ± 1 ℃, 30min for each acupoint, once every other day, three times a week, a total of six weeks treatment. After the treatment, subjects were followed up at weeks 12, 18 and 24.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total efficacy (Adequate relief responder) | The ratio of the number of responders and the total number of participants in each group. Adequate relief responder is the participant who considered effective treatment in the self-assessment. | Week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total efficacy (Adequate relief responder) | Differences in Adequate relief responder between groups | Week 12, 18 and 24 | 
| Symptom severity score (SSS) | Differences in the mean changes of SSS score from baseline between groups | Week 6, 12, 18 and 24 | 
| The proportion of responder to SSS | The differences of the proportion of responders between groups. Defined the SSS score decreased more than 50 points from baseline as responder. | Week 6, 12, 18 and 24 | 
| Bristol stool form scale (BSS) | Differences in the mean changes of BSS score from baseline between groups | Week 6, 12, 18 and 24 | 
| Quality of life questionnaire (IBS-QOL) | Differences in the mean changes of IBS-QOL score from baseline between groups | Week 6 | 
| hospital anxiety and depression score (HADS) | Differences in the mean changes of HADS score from baseline between groups | Week 6 | 
| Self-rating anxiety scale (SAS) | Differences in the mean changes of SAS score from baseline between groups | Week 6 | 
| Self-rating Depression Scale (SDS) | Differences in the mean changes of SDS score from baseline between groups | Week 6 | 
| Diarrhea frequency per day | Differences in the mean changes of Diarrhea frequency per day from baseline between groups | Week 6, 12, 18 and 24 | 
| Urgency of defecation | Differences in the mean changes of Urgency of defecation from baseline | Week 6, 12, 18 and 24 | 
| Safety evaluation (Number of participants with treatment-related adverse events as assessed by CTCAE v4.0) | Eg.moxibustion related burns, blistering, etc | Week 6, 12, 18 and 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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moxibustion, irritable bowel syndrome, Magnetic Resonance Imaging