Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Mucosave® on Gastrointestinal Discomfort

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04119817
Recruitment Status : Completed
First Posted : October 8, 2019
Last Update Posted : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
Azienda Ospedaliera Universitaria Policlinico "G. Martino"

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 to GI discomfort usually have a huge impact on the quality of life. Current treatment for GERD are associated with side effects. In this study, researchers designed a randomized double-blind placebo-controlled trial to assess the effect of Mucosave® on the symptoms and quality of life of healthy adults with gastrointestinal discomfort. One hundred healthy subjects with GI discomfort were enrolled in the study and divided in two groups: 60 and 40 taking for 8 weeks Mucosave® (400 mg/day) or placebo (400 mg/day). To evaluate the effects of treatment, the questionnaires Gastrointestinal Quality of Life index (GIQLI) and GERD Symptom Assessment Scale (GSAS) were self-administered by participants before the beginning of period of supplementation (T0), after four weeks (T4) during the period of supplementation and after 8 weeks (T8) at the end of supplementation.

Condition or disease Intervention/treatment Phase
Gastrointestinal Discomfort Dietary Supplement: Mucosave® capsules Dietary Supplement: Placebo Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, controlled, double blind study
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Clinical Study on the Effects of the Product Mucosave® on Gastrointestinal Discomfort and the Quality of Life in Healthy Volunteers
Actual Study Start Date : February 9, 2019
Actual Primary Completion Date : May 22, 2019
Actual Study Completion Date : July 22, 2019

Arm Intervention/treatment
Experimental: Mucosave® capsules
60 healthy volunteers taking 400 mg/day of Mucosave® capsules for a period of 8 weeks, once a day after dinner before going to bed.
Dietary Supplement: Mucosave® capsules
400 mg/day of Mucosave® capsules for a period of 8 weeks, once a day.

Placebo Comparator: Placebo
40 healthy volunteers taking capsules of placebo for a period of 8 weeks, once a day after dinner before going to bed.
Dietary Supplement: Placebo
400 mg/day of placebo capsules for a period of 8 weeks, once a day.




Primary Outcome Measures :
  1. Evaluation of relief of gastrointestinal disorders with the Gastrointestinal Quality of Life Index (GIQLI) questionnaire. [ Time Frame: 8 weeks ]
    The Gastrointestinal Quality of Life Index (GIQLI) questionnaire contains questions on gastrointestinal symptoms, each with 5 answers in the "Likert scale" style (technique for measuring the attitude), according to the meaning "higher score, better quality of life".

  2. GSAS: an evaluation scale of gastrointestinal symptoms. [ Time Frame: 8 weeks ]
    The GSAS is a 15-item tool designed to evaluate various aspects including stress about gastrointestinal symptoms before and after treatments. It is a simple and easy to understand tool that can be administered in a relatively short time. GSAS is valid, stable and sensitive to changes in symptom over time.


Secondary Outcome Measures :
  1. Satisfaction of supplementation. [ Time Frame: 15 days ]
    Each participant received a daily diary in which they found a few simple multiple choice questions, which helped the investigators to establish the individual degree of satisfaction of treatment. Each participant was asked to answer for the first 15 days of treatment with Mucosave® or placebo to the following questions: How are you today?, How are you compared to yesterday?, Have you had heartburn today?, have you had abdominal swelling today?, Have you had belching today?, Which symptoms were improved today?.

  2. Intestinal microbiota investigation on stool samples [ Time Frame: 8 weeks ]
    Each participant will collect a stool sample before and another at the end of period of supplementation for intestinal microbiota investigation .



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • to be healthy men and women aged between 30 and 50 years; to be able to read, to understand and to sign approval of informed consent; do not use food supplements for gastro-intestinal well-being; to be available to continue own habitual diet; to be a subject without diagnosis of clinical diseases with relevant effects on the gastrointestinal system or visceral motility; to be a subject with reduced bowel movements defined as an average of > 1 and ≤ 3.5 stools per week in the last 6 months; having a BMI = 18-30 kg/m2; to be non-smoker.

Exclusion Criteria:

  • medical 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, participation to the study); people taking drugs that the investigator believes 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, are 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04119817


Locations
Layout table for location information
Italy
Gioacchino Calapai
Messina, Me, Italy, 98125
Sponsors and Collaborators
Azienda Ospedaliera Universitaria Policlinico "G. Martino"
Investigators
Layout table for investigator information
Principal Investigator: Gioacchino Calapai, MD Azienda Ospedaliera Universitaria "G Martino", Messina, Italy.

Publications:

Layout table for additonal information
Responsible Party: Azienda Ospedaliera Universitaria Policlinico "G. Martino"
ClinicalTrials.gov Identifier: NCT04119817     History of Changes
Other Study ID Numbers: MUCOGASDISCOMFORT
First Posted: October 8, 2019    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Azienda Ospedaliera Universitaria Policlinico "G. Martino":
Gastrointestinal symptoms
Nausea
Heartburn
Reflux