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

Nature Science Sp

Status: Completed

Conditions: Abdominal Symptoms; Stool Culture Positive for Candida Species

Treatments: Dietary Supplement: Mycobiotic; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT04909437

EMICH

Details and patient eligibility

About

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.

Enrollment: 105 patients

Sex: All

Ages: 3 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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105 participants in 2 patient groups, including a placebo group

Mycobiotic group

Experimental group

Treatment:

Dietary Supplement: Mycobiotic

Placebo group

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo