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:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2025-12-25 @ 2:39 AM
NCT ID:
NCT04677634
Eligibility Criteria:
Inclusion Criteria:
1. English-speaking male and female adults between the ages of 18 and 75, inclusive
2. Body mass index (BMI) \<35 and \>19, inclusive
3. IBS-C or CIC based on the Rome IV criteria (see Appendix 1) determined via phone interview with the study coordinator and via responses to the questionnaire responses during the Screening Phase
4. History (minimum of three months) of constipation as defined in appendix #1
5. Must be on stable doses of medications, if any, prescribed for chronic conditions other than IBS-C or CIC
6. If female of child-bearing age, must be on an active contraceptive measure or have male partner(s) with suitable protective measures
7. Have access to a computer/tablet/phone with internet access and active e-mail account to complete electronic surveys daily throughout study participation
8. Complete at least 5 of 7 daily BSS daily questionnaires and complete PAC-QOL and PAC-SYM questionnaires during the Screening Phase to enter the Tolerability Phase
9. Complete 5 of 7 BSS daily questionnaires each week and PAC-QOL and PAC-SYM questionnaires at the end of weeks 2 and 4 of the Tolerability Phase to remain in the study
10. Ability and willingness to give consent to participate in study
Exclusion Criteria:
1. Significant comorbidities that are not medically stable
2. History of any abdominal surgery involving the stomach, small or large intestine including appendectomy, cholecystectomy, pancreatic surgery, and any surgery involving abdominal trauma
3. History of diabetes (type I or type II)
4. History of any process that has resulted in abdominal adhesions, thus affecting gut motility
5. History of defecatory or rectal evacuation disorders, which may be based on specific tests such as colonic transition time, manometry evaluation and defecography, such as pelvic floor dyssynergia or a reduction in intra-abdominal pressure (act of bearing down), rectal sensory perception, and rectal contraction (Ohkusa et al. 2019)
6. History of diarrhea predominant or alternating diarrhea/constipation predominant IBS
7. BMI \>=35, BMI \<=19
8. Active history of nicotine use, cannabis use or alcohol abuse (as defined by: greater than 14 drinks/week or 4 drinks/day for men, 7 drinks/week or 3 drinks/day for women). Has used any tobacco, nicotine or cannabis products in the last 6 months or has abused alcohol in the last 6 months
9. Taking any opioids or any other constipating medications within the prior month
10. Must not take, and must not have taken within 3 weeks prior to commencing the Screening Phase, commercially available medications or supplements marketed as prebiotics or probiotics (Supplements such as Metamucil and Citrucel are acceptable in this study)
11. Having taken a 10 day course of a single antibiotic within the past 3 months, \>10 day course of a single antibiotics during the past 5 months, or course of \>1 specific antibiotic within the past 5 months;
12. Has any clinically significant finding which would confound the results, based on a physical exam or clinical laboratory testing after signing the consent but before receiving the first dose of study medication, based on determination by investigator;
13. Reports using a prohibited medication or dietary supplement during the Screening Phase, or is not willing or able to abide by the restrictions regarding use of prohibited medications or dietary supplements;
14. Reports using prokinetics, metformin, regular or frequent antibiotics, systemic glucocorticosteroids, regular non-steroidal anti-inflammatory drugs, sucralfate, ketoconazole, anticholinergics, or misoprostol. The regular intake of acetylsalicylic acid at doses up to 162 mg/day is permitted.
15. Has used an antimicrobial mouth rinse within 1 month of enrollment (e.g. Listerene, etc.);
16. Having ever taken ISOThrive previously
17. History of recurrent infectious condition that requires intermittent antibiotic use
18. If female, is pregnant, lactating, or intending to become pregnant before, during or within 4 weeks after participating in this study or intending to donate ova during such time period
19. Primary sleep disorder including sleep apnea, restless leg syndrome, or insomnia
20. Colon prep or high colonic within 30 days prior to study entry
21. Use of any investigational product within 90 days prior to study entry
22. Participation in another investigation (clinical trial) during the course of this study
23. Participation in a rigorous weight loss program or have any planned changes in diet or lifestyle, such as getting married, change in residence, change in job, or other highly stressful event at any time during the study
24. Diagnosis of inflammatory bowel disease or chronic diarrhea, although a diagnosis of IBS-C or CIC with intermittent short-term diarrhea is acceptable
25. Employment (or relative of an employee) or involvement in any way with ISOThrive Inc.
26. An investigator, key study personnel or first degree relative of anyone involved with the study
27. Other conditions or situations that, in the investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04677634
Study Brief:
Protocol Section:
NCT04677634