Clinical trial NCT02421627: Moxibustion for Diarrhea-predominant Irritable Bowel Syndrome
Official title: Study on the Mechanism of Moxibustion Effect on Treating Diarrhea-predominant Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Keywords: moxibustion
irritable bowel syndrome
Magnetic Resonance Imaging
Lead sponsor: Shanghai Institute of Acupuncture, Moxibustion and Meridian
Sponsor class: OTHER
First posted: 2015-04-20
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 1. A randomized controlled trial
2. Moxibustion treatment, sham control
3. To observe the safety and efficacy of moxibustion treatment versus placebo control
4. Evaluation by intestinal microbial structural and diversity changes using 16S rDNA sequencing
5. Evaluation by structural MRI and resting state-functional MRI
6. Evaluation by ERP

Eligibility criteria: Inclusion Criteria:

1. Diarrhea-predominant IBS patients who met the Rome III diagnostic criteria;
2. Age 18-65 years old, male or female;
3. Volunteered for the trial, signed the informed consent

Exclusion Criteria:

1. Intestinal organic disease;
2. Constipation-predominant IBS;
3. Alternating diarrhea and constipation IBS;
4. Unstructured IBS;
5. At the same time, application of smecta, dicetel, cisapride or traditional Chinese medicine;
6. Combined liver, kidney, heart or mental disease patients;
7. Pregnant or lactating women.

Primary outcomes:
measure: Total efficacy (Adequate relief responder)
timeFrame: Week 6
Secondary outcomes:
measure: Total efficacy (Adequate relief responder)
timeFrame: Week 12, 18 and 24
measure: Symptom severity score (SSS)
timeFrame: Week 6, 12, 18 and 24
measure: The proportion of responder to SSS
timeFrame: Week 6, 12, 18 and 24
measure: Bristol stool form scale (BSS)
timeFrame: Week 6, 12, 18 and 24
measure: Quality of life questionnaire (IBS-QOL)
timeFrame: Week 6
measure: hospital anxiety and depression score (HADS)
timeFrame: Week 6
measure: Self-rating anxiety scale (SAS)
timeFrame: Week 6
measure: Self-rating Depression Scale (SDS)
timeFrame: Week 6
measure: Diarrhea frequency per day
timeFrame: Week 6, 12, 18 and 24
measure: Urgency of defecation
timeFrame: Week 6, 12, 18 and 24
measure: Safety evaluation (Number of participants with treatment-related adverse events as assessed by CTCAE v4.0)
timeFrame: Week 6, 12, 18 and 24
Other outcomes:
measure: Brain structures （gray matter, white matter）MRI
timeFrame: Week 6
measure: resting-state functional MRI
timeFrame: Week 6
measure: Magnetic Resonance Spectroscopy (MRS)
timeFrame: Week 6
measure: Event-related potentials (ERP)
timeFrame: Week 6
measure: Intestinal microbiota changes
timeFrame: Week 6
measure: Brain-gut microbiota interaction
timeFrame: Week 6
Locations:
city: Shanghai
country: China
facility: Shanghai Institute of Acupuncture, Moxibustion and Meridian
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Traditional Chinese Medicine-Integrated Hospital, Shanghai University of Traditional Chinese Medicine
state: Shanghai
city: Shanghai
country: China
facility: Yueyang Integrated Chinese and Western Medicine Hospital, Shanghai University of Traditional Chinese Medicine
state: Shanghai
Study officials:
affiliation: Shanghai University of TCM
name: Huangan Wu, MD,PhD
role: STUDY_CHAIR
References:
citation: Bao C, Wu L, Shi Y, Shi Z, Jin X, Shen J, Li J, Hu Z, Chen J, Zeng X, Zhang W, Ma Z, Weng Z, Li J, Liu H, Wu H. Long-term effect of moxibustion on irritable bowel syndrome with diarrhea: a randomized clinical trial. Therap Adv Gastroenterol. 2022 Feb 23;15:17562848221075131. doi: 10.1177/17562848221075131. eCollection 2022.
citation: Bao C, Zhang J, Liu J, Liu H, Wu L, Shi Y, Li J, Hu Z, Dong Y, Wang S, Zeng X, Wu H. Moxibustion treatment for diarrhea-predominant irritable bowel syndrome: study protocol for a randomized controlled trial. BMC Complement Altern Med. 2016 Oct 24;16(1):408. doi: 10.1186/s12906-016-1386-4.