Abdominal Symptoms, Stool Culture Positive for Candida Species
Conditions
Keywords
stool culture, Candida sp., probiotic, abdominal symptoms
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.
Interventions
DIETARY_SUPPLEMENTMycobiotic
2 sachet/day, 21 days, oral
DIETARY_SUPPLEMENTPlacebo
2 sachet/day, 21 days, oral
Sponsors
Medical Network M. Woynarowski, J. Kierkuś Spółka jawna (MED-NET)
Nature Science Sp. z o.o.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
randomised, double blind, placebo controlled, parallel arm, cross-over
Eligibility
Sex/Gender
ALL
Age
3 Years to 75 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 |
| 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 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Poland
Outcome results
None listed