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

Not Applicable

Completed

• Conditions: Abdominal Symptoms; Stool Culture Positive for Candida Species
• Interventions: Dietary Supplement: Mycobiotic; Dietary Supplement: Placebo

• Registration Number: NCT04909437
• Lead Sponsor: Nature Science Sp. z o.o.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-19
• Study First Submitted: 2021-05-28
• Study First Submitted QC: 2021-05-28
• Study First Posted: 2021-06-01
• Primary Completion: 2022-12-30
• Study Completion: 2022-12-30
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-13
• Last Update Posted: 2023-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

Not provided

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Mycobiotic group	Mycobiotic	-
Placebo group	Placebo	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (6)

Świętokrzyskie Centrum Pediatrii; 🇵🇱 Kielce, Poland

Centrum dr Ozimek; 🇵🇱 Warszawa, Poland

NZOZ Promed; 🇵🇱 Kielce, Poland

Prywatna Specjalistyczna Praktyka Lekarska, dr n. med. Małgorzata Sawicka-Parobczyk; 🇵🇱 Pruszków, Poland

Nowe Zdrowie - CK; 🇵🇱 Staszów, Poland

Świętokrzyskie Centrum Pediatrii - Poradnia Gastroenterologiczna dla Dzieci; 🇵🇱 Kielce, Poland