Completed

NCT Number: NCT04909437

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

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.

Completed

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Key information

Conditions

Abdominal Symptoms Stool Culture Positive for Candida Species

Age range

3 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NZOZ Promed, Kielce, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Mycobiotic

Dietary Supplement

2 sachet/day, 21 days, oral

Placebo

Dietary Supplement

2 sachet/day, 21 days, oral

Primary outcomes

MYCOBIOTIC® influence for the intensity of abdominal pain;

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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 outcomes

Reducuction of the rate of patients with stool culture positive for Candida sp.

Time frame: Day 42 +/-6

to assess whether administration of MYCOBIOTIC® reduces the rate of patients with stool culture positive for Candida sp. in children.

Sponsors and collaborators

Lead sponsor

Nature Science Sp. z o.o.

Industry

Collaborators

Medical Network M. Woynarowski, J. Kierkuś Spółka jawna (MED-NET)

Registry information

Official study title

Efficacy of MYCOBIOTIC® In Children and Adults With Abdominal Symptoms. Double Blind, Placebo Controlled, Prospective, Cross-over Multicenter Study.

Acronym: EMICH

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Jun 1, 2021
Registry last updated: Jan 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.