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| Name | Class |
|---|---|
| Medical Network M. Woynarowski, J. Kierkuś Spółka jawna (MED-NET) | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mycobiotic group | Experimental |
| |
| Placebo group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mycobiotic | Dietary Supplement | 2 sachet/day, 21 days, oral |
| |
| 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 |
| 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 |
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Inclusion criteria
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NZOZ Promed | Kielce | 25-633 | Poland | |||
| Świętokrzyskie Centrum Pediatrii - Poradnia Gastroenterologiczna dla Dzieci |
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randomised, double blind, placebo controlled, parallel arm, cross-over
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| Placebo |
| Dietary Supplement |
2 sachet/day, 21 days, oral |
|
| Kielce |
| 25-736 |
| Poland |
| Świętokrzyskie Centrum Pediatrii | Kielce | 25-736 | Poland |
| Prywatna Specjalistyczna Praktyka Lekarska, dr n. med. Małgorzata Sawicka-Parobczyk | Pruszków | 05-804 | Poland |
| Nowe Zdrowie - CK | Staszów | 28-200 | Poland |
| Centrum dr Ozimek | Warsaw | 02-765 | Poland |