Mild to moderate Gastro-Esophageal Reflux Disease (GERD) Digestive System
Conditions
Interventions
Healthy male and female subjects aged from 18 to 50 years old (included) were enrolled and equally allocated to the placebo and food supplement group by using a computer-generated restricted randomize
Sponsors
Nutratech Srl
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy male and female subjects aged 18 to 50 years old (inclusive), aware of the study procedures and having signed an informed consent form 2. Subjects who experienced mild or moderate heartburn according to Dyspepsia questionnaire (modified Leeds card) 3. Subjects used over-the-counter (OTC) products for heartburn, food supplements, or dietary manipulation to relieve heartburn symptoms during the previous 3 months 4. Willingness not to use products apart from the product tested throughout the study period and antiacids** 5. Willingness not to vary the normal daily routine (i.e. lifestyle, physical activity, usual diet, fluid intake etc) 6. Subjects under effective contraception (oral/not oral) therapy 7. Available and willing to follow the procedure of the study protocol 8. Subjects who have not been recently involved in any other similar study (at least 2 months of wash-out) 9. Subjects registered with the National Health Service (NHS) 10. Willingness to respect the instructions given by the investigator as well as to respect the study constraints and specific requirements 11. The pharmacological therapy (except for the pharmacological therapy in the non-inclusion criteria) should be stable for at least 1 month without any changes expected or planned during the study
Exclusion criteria
Exclusion criteria: 1. Subjects not fulfilling the inclusion criteria above 2. Alimentary/eating disorders (i.e. bulimia, psychogenic eating disorders, etc) 3. Severe heartburn problem during the week prior to the study 4. Previous or current treatment for any gastrointestinal diseases or illnesses 5. Diagnosis of Barrett’s esophagus 6. Previous upper gastrointestinal surgery 7. Clinically significant GI bleeding within the last 3 months 8. Esophagitis not related to acid reflux 9. Known hypersensitivity or allergy to one of the active ingredients 10. Bleeding disorder, Zollinger–Ellison Syndrome, duodenal/gastric ulcer and upper gastrointestinal malignancy 11. Alcohol or drug abuse 12. Under pharmacological treatments (abuse of FANS, antibiotics, etc) known to interfere with the tested product 13. Clinical history with relevant presence of any disorder or administration of drugs/food supplement that can potentially interfere with the treatment under study 14. Pregnant or breastfeeding women 15. Known food intolerance or food allergy 16. Unstable medical diseases (cardiac arrhythmias or ischemia, uncontrolled hypertension and hypotension, diabetes mellitus, kidney failure) 17. History of paralysis or cerebral vascular accident 18. Subjects participating or planning to participate in other clinical trials 19. Adult protected by the law (under guardianship, or hospitalized in a public or private institution, for a reason other than the research, or incarcerated)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Heartburn episodes in adult subjects with mild to moderate GERD, measured using a questionnaire evaluating the severity and frequency of episodes on a daily basis for 28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life in subjects with mild to moderate GERD, measured using a questionnaire (GERD QOL) at T0-T14 and T28 | — |
Countries
Italy
Contacts
Public ContactAmelia Spina
Outcome results
None listed