N/A
Completed N=31
Effect of Tai Chi as Treatment for IBS-C
Irritable Bowel Syndrome With Constipation
Source: ClinicalTrials.gov NCT04132804 ↗
Enrolled (actual)
31
Serious AEs
3.2%
Results posted
Oct 2021
Primary outcomePrimary: IBS Symptom Severity Score at 12 Weeks — 184.7 score on a scale
Summary
The purpose of the study is to evaluate the efficacy of Tai Chi practice in reducing symptoms of Irritable Bowel Syndrome with Constipation (IBS-C).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY IBS Symptom Severity Score at 12 Weeks |
184.7 | — |
| SECONDARY Likelihood of Continuing Treatment |
4.2 | — |
| SECONDARY Treatment Satisfaction |
4 | — |
| SECONDARY IBS Quality of Life (IBS-QOL) at 12 Weeks |
79.8 | — |
| SECONDARY Daily Bowel Movement Frequency at 12 Weeks |
1.4 | — |
| SECONDARY Bloating Scale Score at 12 Weeks |
4.1 | — |
| SECONDARY Abdominal Discomfort Scale Score at 12 Weeks |
3.3 | — |
| SECONDARY Constipation Severity Scale Score at 12 Weeks |
3.4 | — |
| SECONDARY Hospital Anxiety and Depression Scale (HADS) Score at 12 Weeks |
13.3 | — |
| SECONDARY Visceral Sensitivity Index (VSI) Score at 12 Weeks |
53.6 | — |
| SECONDARY Stool Microbiome |
— | — |
| SECONDARY Global Assessment of Relief at 12 Weeks |
3.4 | — |
Eligibility Criteria
Inclusion
- Age 18 - 70 years
- BMI ≤ 35
- Rome IV criteria for IBS-C
- Continued IBS-C throughout run-in period
- Compliant with reporting during run-in
- Ability to follow verbal and written instructions
- Ability to record daily patient reported outcomes via RedCap survey
- Ability to use the GeoPain app on a smart phone
- Ability to use Zoom as a platform for conducting study visits virtually
- Ability to respond to 80% of the daily diaries
- Ability to attend at least 7 out of 8 Tai Chi classes
- Informed consent form signed by the subjects
Exclusion
- Unwilling to abstain from participation in Tai Chi (other than that provided for the study) or other mind-body practices (i.e. yoga that is new to regimen) until completion of the study
- Non-English speaking
- Participation in any other clinical trial with active intervention within the last 30 days
- Non-compliance with reporting during run-in period
- Inability to stand without assistance for 20 minutes
- Patients reporting any usage of a prohibited medication during the run-in period
- History of regular opiate or narcotic pain-reliever use
- Current use of prescribed or illicit opioids
- Change in current medication regimen related to GI motility, laxatives, or antidepressants
- Abdominal pain severity of 4 on a 0-4 visual analogue scale, where 4 is the worst possible pain, during pre-screen or run-in
- Severe osteoarthritis
- Severe rheumatoid arthritis
- Severe constipation defined as 35
- Pregnancy (or positive urine pregnancy test(s) in females of childbearing potential)
- Known history of diabetes (type 1 or 2)
- History of gastroparesis
- History of abdominal radiation treatment
- History of pancreatitis
- History of malabsorption or celiac disease
- History of intestinal obstruction or subjects at high risk of intestinal obstruction including suspected small bowel adhesions
- History of human immunodeficiency virus
- History of cancer within the past 5 years (except adequately-treated localized basal cell skin cancer or in situ uterine cervical cancer)
- Neurological disorders, metabolic disorders, or other significant disease that would impair their ability to participate in the study
- Any other clinically significant disease interfering with the assessments according to the Investigator (e.g., disease requiring corrective treatment, potentially leading to study discontinuation)
- Any relevant biochemical abnormality interfering with the assessments according to the Investigator
- Inability to attend at least 7 out of the 8 Tai Chi classes
- Inability to respond to 80% of the daily diaries
Data sourced from ClinicalTrials.gov (NCT04132804). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.