Clinical trial NCT04909437: Efficacy of MYCOBIOTIC® in Children and Adults With Abdominal Symptoms.
Official title: Efficacy of MYCOBIOTIC® In Children and Adults With Abdominal Symptoms. Double Blind, Placebo Controlled, Prospective, Cross-over Multicenter Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Symptoms
Stool Culture Positive for Candida Species
Keywords: stool culture
Candida sp.
probiotic
abdominal symptoms
Lead sponsor: Nature Science Sp. z o.o.
Sponsor class: INDUSTRY
Collaborators: name: Medical Network M. Woynarowski, J. Kierkuś Spółka jawna (MED-NET)
First posted: 2021-06-01
Enrollment: 105
Sex: ALL
Minimum age (years): 3
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: randomised, double blind, placebo controlled, parallel arm, cross-over
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: MYCOBIOTIC® influence for the intensity of abdominal pain;
timeFrame: Day 21+/-3; Day 42+/-3, Day 49 +/-3
measure: MYCOBIOTIC® influence for the intensity of stool frequency and consistency
timeFrame: Day 21+/-3; Day 42+/-3, Day 49 +/-3
measure: MYCOBIOTIC® influence for the intensity of abdominal distention
timeFrame: Day 21+/-3; Day 42+/-3, Day 49 +/-3
measure: MYCOBIOTIC® influence for the intensity of vomiting
timeFrame: Day 21+/-3; Day 42+/-3, Day 49 +/-3
measure: MYCOBIOTIC® influence for the intensity of abdominal bloating
timeFrame: Day 21+/-3; Day 42+/-3, Day 49 +/-3
Secondary outcomes:
measure: Reducuction of the rate of patients with stool culture positive for Candida sp.
timeFrame: Day 42 +/-6
Other outcomes:
Locations:
city: Kielce
country: Poland
facility: NZOZ Promed
city: Kielce
country: Poland
facility: Świętokrzyskie Centrum Pediatrii - Poradnia Gastroenterologiczna dla Dzieci
city: Kielce
country: Poland
facility: Świętokrzyskie Centrum Pediatrii
city: Pruszków
country: Poland
facility: Prywatna Specjalistyczna Praktyka Lekarska, dr n. med. Małgorzata Sawicka-Parobczyk
city: Staszów
country: Poland
facility: Nowe Zdrowie - CK
city: Warszawa
country: Poland
facility: Centrum dr Ozimek
Study officials:
References: