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

Nature Science Sp. z o.o.105 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

105

Conditions

Abdominal Symptoms Stool Culture Positive for Candida Species

Interventions

MycobioticDIETARY_SUPPLEMENT

2 sachet/day, 21 days, oral

PlaceboDIETARY_SUPPLEMENT

2 sachet/day, 21 days, oral

Eligibility

Sex: ALLMin age: 3 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion criteria 1. Children and adults age \>3 up to ≤ 75 years old. Boys and girls aged 3-15 years 2. Presence of abdominal symptoms 3. Informed consent for participation in the study signed by children' parents/ legal caregivers and child above 13 years old, all adults patients. Exclusion Criteria: 1. Chronic intestinal disease, immunodeficiency or immunosuppressive treatment. 2. Chronic or acute diarrheal disease. 3. Use of laxatives or antydiarrhoeal treatment within the week before inclusion in the study. 4. Antibiotic treatment for the last four weeks before inclusion in the study. 5. Intake of probiotic products for the last two weeks before inclusion in the study 6. Known hypersensitivity to any of the ingredients in the probiotic product or the placebo (corn starch, magnesium stearate ± bacterial culture).

Locations (6)

NZOZ Promed

Kielce, Poland

Świętokrzyskie Centrum Pediatrii - Poradnia Gastroenterologiczna dla Dzieci

Kielce, Poland

Świętokrzyskie Centrum Pediatrii

Kielce, Poland

Prywatna Specjalistyczna Praktyka Lekarska, dr n. med. Małgorzata Sawicka-Parobczyk

Pruszków, Poland

Outcomes

Primary Outcomes

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;