Status:
COMPLETED
Efficacy of MYCOBIOTIC® in Children and Adults With Abdominal Symptoms.
Lead Sponsor:
Nature Science Sp. z o.o.
Collaborating Sponsors:
Medical Network M. Woynarowski, J. Kierkuś Spółka jawna (MED-NET)
Conditions:
Abdominal Symptoms
Stool Culture Positive for Candida Species
Eligibility:
All Genders
3-75 years
Phase:
NA
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 ou...
Eligibility Criteria
Inclusion
- 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).
Exclusion
Key Trial Info
Start Date :
May 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2022
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT04909437
Start Date
May 19 2021
End Date
December 30 2022
Last Update
January 17 2023
Active Locations (6)
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1
NZOZ Promed
Kielce, Poland, 25-633
2
Świętokrzyskie Centrum Pediatrii - Poradnia Gastroenterologiczna dla Dzieci
Kielce, Poland, 25-736
3
Świętokrzyskie Centrum Pediatrii
Kielce, Poland, 25-736
4
Prywatna Specjalistyczna Praktyka Lekarska, dr n. med. Małgorzata Sawicka-Parobczyk
Pruszków, Poland, 05-804