Effects of Mucosave® on Gastrointestinal Discomfort

NCT04119817 | Completed

• 1 other identifier: MUCOGASDISCOMFORT
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Discomfort

Keywords

Gastrointestinal symptoms; Nausea; Heartburn; Reflux

Outcome Measures

Primary Outcomes (2)

• Evaluation of relief of gastrointestinal disorders with the Gastrointestinal Quality of Life Index (GIQLI) questionnaire.

  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.

  8 weeks

• Evaluation of relief of gastrointestinal symptoms with the Gastroesophageal Reflux Disease Symptom Assessment Scale (GSAS): an evaluation scale of gastrointestinal symptoms.

  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.

  8 weeks

Secondary Outcomes (2)

• Satisfaction of supplementation.

  15 days

• Intestinal microbiota investigation on stool samples

  8 weeks

Study Arms (2)

Mucosave® capsules

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Mucosave® capsules DIETARY_SUPPLEMENT

400 mg/day of Mucosave® capsules for a period of 8 weeks, once a day.

Mucosave® capsules

Placebo DIETARY_SUPPLEMENT

400 mg/day of placebo capsules for a period of 8 weeks, once a day.

Placebo

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Policlinico "G. Martino": lead

Study Sites (1)

Gioacchino Calapai

Messina, Me, 98125, Italy

Location

Related Publications (17)

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MeSH Terms

Conditions

Nausea; Heartburn; Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Gioacchino Calapai, MD

  Azienda Ospedaliera Universitaria "G Martino", Messina, Italy.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, controlled, double blind study

Study Record Dates

• First Submitted: September 19, 2019
• First Posted: October 8, 2019
• Study Start: February 9, 2019
• Primary Completion: May 22, 2019
• Study Completion: July 22, 2019
• Last Updated: February 5, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)