Effects of Mucosave® on Gastrointestinal Discomfort
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|ClinicalTrials.gov Identifier: NCT04119817|
Recruitment Status : Completed
First Posted : October 8, 2019
Last Update Posted : February 5, 2020
|Condition or disease||Intervention/treatment||Phase|
|Gastrointestinal Discomfort||Dietary Supplement: Mucosave® capsules Dietary Supplement: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized, controlled, double blind study|
|Masking:||Double (Participant, Care Provider)|
|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|
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.
- 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.
- 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.
- 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?.
- 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 .
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
|Messina, Me, Italy, 98125|
|Principal Investigator:||Gioacchino Calapai, MD||Azienda Ospedaliera Universitaria "G Martino", Messina, Italy.|