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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. Identifier: NCT04119817
Recruitment Status : Completed
First Posted : October 8, 2019
Last Update Posted : February 5, 2020
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

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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". The GIQLI is an appropriate, validated and potentially useful tool to assess health-related quality of life in clinical studies of patients with gastrointestinal disease.

    Each of the 36 items is scored on a five-point scale (0 to 4) denoting the burden of the particular symptom or dysfunction. The total score ranged from 0 (worst) to 144 (best quality of life) with higher scores representing better quality of life. Subscales can be summarized or averaged.

  2. Evaluation of relief of gastrointestinal symptoms with the Gastroesophageal Reflux Disease Symptom Assessment Scale (GSAS): an evaluation scale of gastrointestinal symptoms. [ Time Frame: 8 weeks ]

    GSAS is a 15-item tool designed to evaluate various aspects including stress about gastrointestinal symptoms before and after treatments. GSAS is a self-administered questionnaire that asks patients to report about the previous week for 15 specific symptoms: heartburn, a feeling of pressure inside chest, food coming back into mouth, an acid in mouth, frequent gurgling, feeling of lump in throat, nausea, burning pain in throat, bloating, belching, flatulence, feeling full after eating, bad breath, coughing, and hoarseness.

    Scoring of the GSAS distress subscale is based on the presence of the symptoms and their bother ratings. Specifically, patients first indicate whether they had the symptom in the past week. If they did not have the symptom, their score for the symptom is 0. If they did have the symptom, they then report how bothered they were by it on a 4-point scale (0 ? not at all, 1 ? somewhat, 2 ? quite a bit, 3 ? very much). Subscales can be summarized or averaged.

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

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Ages Eligible for Study:   30 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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 Criteria:

  • 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.

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 identifier (NCT number): NCT04119817

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Gioacchino Calapai
Messina, Me, Italy, 98125
Sponsors and Collaborators
Azienda Ospedaliera Universitaria Policlinico "G. Martino"
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Principal Investigator: Gioacchino Calapai, MD Azienda Ospedaliera Universitaria "G Martino", Messina, Italy.

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Responsible Party: Azienda Ospedaliera Universitaria Policlinico "G. Martino" Identifier: NCT04119817    
First Posted: October 8, 2019    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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