Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2025-12-24 @ 9:16 PM
NCT ID:
NCT04132804
Eligibility Criteria:
Inclusion
1. Age 18 - 70 years
2. BMI ≤ 35
3. Rome IV criteria for IBS-C
4. Continued IBS-C throughout run-in period
5. Compliant with reporting during run-in
6. Ability to follow verbal and written instructions
7. Ability to record daily patient reported outcomes via RedCap survey
8. Ability to use the GeoPain app on a smart phone
9. Ability to use Zoom as a platform for conducting study visits virtually
10. Ability to respond to 80% of the daily diaries
11. Ability to attend at least 7 out of 8 Tai Chi classes
12. Informed consent form signed by the subjects
Exclusion
1. 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
2. Non-English speaking
3. Participation in any other clinical trial with active intervention within the last 30 days
4. Non-compliance with reporting during run-in period
5. Inability to stand without assistance for 20 minutes
6. Patients reporting any usage of a prohibited medication during the run-in period
7. History of regular opiate or narcotic pain-reliever use
8. Current use of prescribed or illicit opioids
9. Change in current medication regimen related to GI motility, laxatives, or antidepressants
10. 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
11. Severe osteoarthritis
12. Severe rheumatoid arthritis
13. Severe constipation defined as \<1 bowel movement per week without use of laxatives
14. History of GI lumen surgery (including gastric bypass) at any time or other GI or abdominal operations within 60 days prior to entry into the study
15. History of small bowel resection (except if related to appendectomy)
16. Subjects anticipating surgical intervention during the study
17. Angina, coronary bypass, or myocardial infarction within 6 months prior to Screening Visit
18. Crohn's disease or ulcerative colitis
19. History of intestinal stricture (e.g., Crohn's disease)
20. BMI \>35
21. Pregnancy (or positive urine pregnancy test(s) in females of childbearing potential)
22. Known history of diabetes (type 1 or 2)
23. History of gastroparesis
24. History of abdominal radiation treatment
25. History of pancreatitis
26. History of malabsorption or celiac disease
27. History of intestinal obstruction or subjects at high risk of intestinal obstruction including suspected small bowel adhesions
28. History of human immunodeficiency virus
29. History of cancer within the past 5 years (except adequately-treated localized basal cell skin cancer or in situ uterine cervical cancer)
30. Neurological disorders, metabolic disorders, or other significant disease that would impair their ability to participate in the study
31. Any other clinically significant disease interfering with the assessments according to the Investigator (e.g., disease requiring corrective treatment, potentially leading to study discontinuation)
32. Any relevant biochemical abnormality interfering with the assessments according to the Investigator
33. Inability to attend at least 7 out of the 8 Tai Chi classes
34. Inability to respond to 80% of the daily diaries
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04132804
Study Brief:
Protocol Section:
NCT04132804