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

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

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 Overview

• Status: Completed
• Conditions: Abdominal Symptoms; Stool Culture Positive for Candida Species
• Intervention / Treatment: Dietary supplement: Mycobiotic; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Kielce, Poland, 25-633
    • NZOZ Promed
  • Kielce, Poland, 25-736
    • Świętokrzyskie Centrum Pediatrii - Poradnia Gastroenterologiczna dla Dzieci
  • Kielce, Poland, 25-736
    • Świętokrzyskie Centrum Pediatrii
  • Pruszków, Poland, 05-804
    • Prywatna Specjalistyczna Praktyka Lekarska, dr n. med. Małgorzata Sawicka-Parobczyk
  • Staszów, Poland, 28-200
    • Nowe Zdrowie - CK
  • Warszawa, Poland, 02-765
    • Centrum dr Ozimek

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo group	Dietary supplement: Placebo; 2 sachet/day, 21 days, oral
Experimental: Mycobiotic group	Dietary supplement: Mycobiotic; 2 sachet/day, 21 days, oral

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Nature Science Sp. z o.o.
• Collaborators: Medical Network M. Woynarowski, J. Kierkuś Spółka jawna (MED-NET)

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2021
• Primary Completion (Actual): December 30, 2022
• Study Completion (Actual): December 30, 2022

Study Registration Dates

• First Submitted: May 28, 2021
• First Submitted That Met QC Criteria: May 28, 2021
• First Posted (Actual): June 1, 2021

Study Record Updates

• Last Update Posted (Estimate): January 16, 2023
• Last Update Submitted That Met QC Criteria: January 13, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: probiotic; stool culture; Candida sp.; abdominal symptoms
• Other Study ID Numbers: EMICH

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No