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 @ 2:30 AM
Ignite Modification Date:
2025-12-25 @ 2:30 AM
NCT ID:
NCT04491734
Eligibility Criteria:
Inclusion Criteria:
1. English-speaking male and female adults between the ages of 25 and 75, inclusive
2. Body mass index (BMI) \<35 and \>19
3. Either 3.a. or 3.b. or both, based on the Screening Phase ReQuest Short and Long Version responses:
1. At least one incidence of (a) acid complaints; (b) upper abdominal/stomach complaints and RQ Total score \>3.37 or RQ-GI score \>0.95
2. Four days or more of combined incidence of (a) acid complaints; (b) upper abdominal/stomach complaints.
4. History (minimum of three months) of GERD symptoms as defined in #3 above
5. Must be on stable doses of medications, if any, prescribed for chronic conditions other than GERD
6. If female, 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 in order to complete electronic surveys daily throughout study participation
8. Ability and willingness to give consent to participate in study
Exclusion Criteria:
1. Significant comorbidities that are not medically stable
2. History of scleroderma, diabetes, Barrett's esophagus, esophageal cancer, esophageal stricture, or esophageal scarring (fibrosis)
3. Known hiatal hernia \> 2cm
4. Positive diagnosis for Helicobacter pylori (HP) or has had an HP infection within 45 days of study entry
5. History of surgery or endoscopic treatment including fundoplication and dilation for esophageal stricture
6. History of gastric surgery (except for endoscopic removal of benign polyps) or bariatric surgery
7. BMI \>=35, BMI \<=19
8. History of diseases that have symptoms that may be confused with GERD, such as eosinophilic esophagitis, angina, gastritis, esophageal spasm, rumination, or other conditions involving the mouth, throat, chest or abdomen
9. 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
10. Taking any excluded medications listed in the protocol (e.g. metformin, antibiotics within the prior 6 months.)
11. 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
12. Primary sleep disorder including sleep apnea, restless leg syndrome, or insomnia
13. Colon prep within 30 days prior to study entry
14. Use of any investigational product within 90 days prior to study entry
15. Participation in another investigation (clinical trial) during the course of this study
16. 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
17. Diagnosis of inflammatory bowel disease, irritable bowel syndrome, or chronic diarrhea (mild chronic constipation is allowed)
18. Employment (or relative of an employee) or involvement in any way with ISOThrive Inc.
19. An investigator, key study personnel or first degree relative of anyone involved with the study
20. 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:
False
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
75 Years
Study:
NCT04491734
Study Brief:
Protocol Section:
NCT04491734