A food supplement based on probiotics, vitamin PP and vitamin B2 can improve heartburn symptoms/dyspeptic disorders and heartburn-related quality of life in subjects with mild to moderate gastroesophageal reflux disease (GERD)

Not Applicable

Completed

• Conditions: Mild to moderate Gastro-Esophageal Reflux Disease (GERD); Digestive System

• Registration Number: ISRCTN96068143
• Lead Sponsor: utratech Srl

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-12-01
• Study Start: 2024-01-31
• Last Update Posted: 12 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 56

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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified