Status:
COMPLETED
Effects of Mucosave® on Gastrointestinal Discomfort
Lead Sponsor:
Azienda Ospedaliera Universitaria Policlinico "G. Martino"
Conditions:
Gastrointestinal Discomfort
Eligibility:
All Genders
30-50 years
Phase:
NA
Brief Summary
Gastrointestinal (GI) discomfort, which often includes gastroesophageal reflux disease (GERD) is a common disorder in healthy adults affecting 20% of people particularly women. The disorders related t...
Detailed Description
Gastrointestinal (GI) discomfort is a common disorder in healthy adults with a prevalence of 20%, particularly affecting women. Gut health is gaining more interest nowadays for a variety of reasons in...
Eligibility Criteria
Inclusion
- healthy men and women aged between 30 and 50 years;
- subjects able to read, to understand and to sign approval of informed consent;
- subjects not using food supplements for gastro-intestinal well-being;
- subjects available to continue own habitual diet;
- subjects without diagnosis of clinical diseases with relevant effects on the gastrointestinal system or visceral motility;
- subjects with reduced bowel movements defined as an average of \> 1 and ≤ 3.5 stools per week in the last 6 months;
- subjects with BMI = 18-30 kg/m2;
- non-smoker subjects.
Exclusion
- history of gastroesophageal surgery or endoscopic therapy due to severe erosive esophagitis;
- presence of Barrett's esophagus;
- subjects with uncontrolled or severe medical problems such as asthma, angina, hepatic or kidney diseases;
- subjects aged \< 30 or \> 50 years;
- presence of acute or chronic inflammatory processes requiring therapy;
- presence of acute or chronic coexisting diseases (cardiovascular, gastrointestinal, endocrinological, immunological, metabolic or any other condition that contraindicates, in the opinion of the investigators, the participation to the study);
- subjects taking drugs that, in the opinion of the investigator, may interfere with the objectives of the study or represent a safety risk or can confuse the interpretation of the study results including heartburn medication, probiotics and prebiotics;
- subjects that, in the opinion of the investigator, can be considered as potential participants, but for whatever reason are not able to respect the protocol of the study;
- pregnant or nursing women;
- subjects who cannot receive treatment with experimental drugs; subject participating in a recent experimental study (this must have been performed no less than 30 days prior to this study);
- subjects affected by neoplasms.
Key Trial Info
Start Date :
February 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 22 2019
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04119817
Start Date
February 9 2019
End Date
July 22 2019
Last Update
February 5 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Gioacchino Calapai
Messina, Me, Italy, 98125