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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-19

Study Completion Date

2022-12-30

Brief Summary

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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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Detailed Description

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Conditions

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Abdominal Symptoms Stool Culture Positive for Candida Species

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

randomised, double blind, placebo controlled, parallel arm, cross-over

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Mycobiotic group

Group Type EXPERIMENTAL

Mycobiotic

Intervention Type DIETARY_SUPPLEMENT

2 sachet/day, 21 days, oral

Placebo group

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

2 sachet/day, 21 days, oral

Interventions

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Mycobiotic

2 sachet/day, 21 days, oral

Intervention Type DIETARY_SUPPLEMENT

Placebo

2 sachet/day, 21 days, oral

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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).

Minimum Eligible Age

3 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No