Efficacy of MYCOBIOTIC® in Children and Adults With Abdominal Symptoms.

Study Overview
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Brief Summary
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This is a prospective, randomised, double blind, placebo controlled, parallel arm, cross-over, multicentre study conducted in a population of children and adults with abdominal symptoms observed at outpatient primary health care centres.

Official Title
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Efficacy of MYCOBIOTIC® In Children and Adults With Abdominal Symptoms. Double Blind, Placebo Controlled, Prospective, Cross-over Multicenter Study.

Conditions
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Abdominal Symptoms, Stool Culture Positive for Candida Species

Intervention / Treatment
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* Dietary Supplement: Mycobiotic
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Children and adults age >3 up to ≤ 75 years old. Boys and girls aged 3-15 years Presence of abdominal symptoms Informed consent for participation in the study signed by children' parents/ legal caregivers and child above 13 years old, all adults patients. Exclusion Criteria: Chronic intestinal disease, immunodeficiency or immunosuppressive treatment. Chronic or acute diarrheal disease. Use of laxatives or antydiarrhoeal treatment within the week before inclusion in the study. Antibiotic treatment for the last four weeks before inclusion in the study. Intake of probiotic products for the last two weeks before inclusion in the study Known hypersensitivity to any of the ingredients in the probiotic product or the placebo (corn starch, magnesium stearate ± bacterial culture).

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: randomised, double blind, placebo controlled, parallel arm, cross-over
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mycobiotic group<br> | Dietary Supplement: Mycobiotic<br>* 2 sachet/day, 21 days, oral<br>|
| Placebo Comparator: Placebo group<br> | Dietary Supplement: Placebo<br>* 2 sachet/day, 21 days, oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MYCOBIOTIC® influence for the intensity of abdominal pain; | to assess if administration of MYCOBIOTIC® have influence to the intensity of the abdominal symptoms reported by parents or caregivers in questionaire- abdominal pain; | Day 21+/-3; Day 42+/-3, Day 49 +/-3 | 
| MYCOBIOTIC® influence for the intensity of stool frequency and consistency | to assess if administration of MYCOBIOTIC® have influence to the intensity of the abdominal symptoms reported by parents or caregivers in questionaire- stool frequency and consistency | Day 21+/-3; Day 42+/-3, Day 49 +/-3 | 
| MYCOBIOTIC® influence for the intensity of abdominal distention | to assess if administration of MYCOBIOTIC® have influence to the intensity of the abdominal symptoms reported by parents or caregivers in questionaire- abdominal distention | Day 21+/-3; Day 42+/-3, Day 49 +/-3 | 
| MYCOBIOTIC® influence for the intensity of vomiting | to assess if administration of MYCOBIOTIC® have influence to the intensity of the abdominal symptoms reported by parents or caregivers in questionaire- vomiting | Day 21+/-3; Day 42+/-3, Day 49 +/-3 | 
| MYCOBIOTIC® influence for the intensity of abdominal bloating | to assess if administration of MYCOBIOTIC® have influence to the intensity of the abdominal symptoms reported by parents or caregivers in questionaire- abdominal bloating | Day 21+/-3; Day 42+/-3, Day 49 +/-3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reducuction of the rate of patients with stool culture positive for Candida sp. | to assess whether administration of MYCOBIOTIC® reduces the rate of patients with stool culture positive for Candida sp. in children. | Day 42 +/-6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stool culture, Candida sp., probiotic, abdominal symptoms