Abdominal SymptomsEMICHNCT04909437
Efficacy of MYCOBIOTIC® in Children and Adults With Abdominal Symptoms.
A study testing Mycobiotic in people with Abdominal Symptoms and Stool Culture Positive for Candida Species, run by Nature Science Sp. z o.o. at 6 sites in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 75 years
- Conditions the study is for
- Abdominal Symptoms, Stool Culture Positive for Candida Species
- What is being tested?
- Mycobiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 6 sitesPoland
- Study dates
- 19 May 2021to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Poland6 sites
NZOZ Promed
Kielce, 25-633
Świętokrzyskie Centrum Pediatrii - Poradnia Gastroenterologiczna dla Dzieci
Kielce, 25-736
Świętokrzyskie Centrum Pediatrii
Kielce, 25-736
Prywatna Specjalistyczna Praktyka Lekarska, dr n. med. Małgorzata Sawicka-Parobczyk
Pruszków, 05-804
Nowe Zdrowie - CK
Staszów, 28-200
Centrum dr Ozimek
Warsaw, 02-765
About this study
Official title: Efficacy of MYCOBIOTIC® In Children and Adults With Abdominal Symptoms. Double Blind, Placebo Controlled, Prospective, Cross-over Multicenter Study.
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.
- Being tested
- Mycobiotic, Placebo
- Keywords
- stool culture, Candida sp., probiotic, abdominal symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MycobioticDietary supplement
2 sachet/day, 21 days, oral
PlaceboDietary supplement
2 sachet/day, 21 days, oral
| Study group | Role | What they receive |
|---|---|---|
| Mycobiotic group | Experimental | Not described Receives: Dietary Supplement: Mycobiotic |
| Placebo group | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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;
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Day 21+/-3; Day 42+/-3, Day 49 +/-3
Secondary outcomes (1)
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.
Measured: Day 42 +/-6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start19 May 2021
- Primary completion30 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- randomised, double blind, placebo controlled, parallel arm, cross-over
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nature Science Sp. z o.o.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medical Network M. Woynarowski, J. Kierkuś Spółka jawna (MED-NET)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04909437
- Sponsor's protocol ID
- EMICH
- Acronym
- EMICH
- Status last verified
- Jan 2023
- First submitted
- 28 May 2021
- Last updated
- 17 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of MYCOBIOTIC® In Children and Adults With Abdominal Symptoms. Double Blind, Placebo Controlled, Prospective, Cross-over Multicenter Study.
- ClinicalTrials.gov ID
- NCT04909437
- Acronym / sponsor ID
- EMICH / EMICH
- Keywords
- stool culture, Candida sp., probiotic, abdominal symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Nature Science Sp. z o.o.Industry (pharma, biotech, devices)
- Collaborators
- Medical Network M. Woynarowski, J. Kierkuś Spółka jawna (MED-NET)
- Study start
- 19 May 2021 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 1 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomised, double blind, placebo controlled, parallel arm, cross-over
| Arm | Type | Receives |
|---|---|---|
| Mycobiotic group | Experimental | Dietary Supplement: Mycobiotic |
| Placebo group | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 3 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mycobiotic2 sachet/day, 21 days, oral | Dietary supplement | Mycobiotic group |
| Placebo2 sachet/day, 21 days, oral | Dietary supplement | Placebo group |
Primary outcome
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
1 secondary outcome
Reducuction of the rate of patients with stool culture positive for Candida sp.
Time frame: Day 42 +/-6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mycobiotic in people with Abdominal Symptoms and Stool Culture Positive for Candida Species, run by Nature Science Sp. z o.o. at 6 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MYCOBIOTIC® influence for the intensity of abdominal pain; (time frame: Day 21+/-3; Day 42+/-3, Day 49 +/-3). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2023.