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 @ 2:53 PM
Ignite Modification Date:
2025-12-24 @ 2:53 PM
NCT ID:
NCT01444859
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥18 years
2. Body mass index between 18.5 through 39.9 kg/m2
3. At least three symptoms rated between 4 to 6 in severity (moderate to severe discomfort) on a 1 to 7 scale, one of which must be acid indigestion as determined by the "Reflux Syndrome" score
4. Self-reported "acid indigestion" symptoms (including pain/discomfort beneath the breastbone, bitter fluid in the mouth, or bloating/nausea after eating) at least 3 times per week over the previous 4 weeks
5. Agree to use contraception throughout study period, unless postmenopausal or surgically sterile (females only)
6. Able to understand and voluntarily consent to the study and understand it's nature and purpose including potential risks, and side effects
Exclusion Criteria:
1. Any GSRS symptom rated a 7 in severity (very severe discomfort) on a 1 to 7 scale
2. Diagnosed gastrointestinal disease/complication or functional bowel disorder (e.g. IBS, functional constipation, IBD, ulcer, etc.) based on physical examination or documented medical history that, in the investigator's opinion, may affect subject safety or confound the evaluation of the study endpoints
3. Any non-gastrointestinal disease/complication that, in the investigator's opinion, may affect subject safety or confound the evaluation of the study endpoints
4. Regular (\>3 days per week) prescription medication use for any gastrointestinal disease/condition
5. Recent (\<6 months) abdominal surgery for any reason
6. Immunodeficiency
7. Recent change in anti-psychotic medication within the previous 3 months
8. Systemic steroid use within the prior month, excluding regular use of asthma medication
9. Pregnant female or breastfeeding
10. Eating disorder
11. Recent (within 2 weeks) antibiotic administration
12. History of alcohol, drug, or medication abuse
13. Daily consumption of probiotics, fermented milk, and/or yogurt
14. Known allergies to any substance in the study product
15. Participation in another study with any investigational product within 30 days of screening
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01444859
Study Brief:
Protocol Section:
NCT01444859