JPRN-jRCTs051200039
Recruiting
Phase 4
on-control clinical trial of the effect on airway endocrine products by synbiotic administration
Bitoh Yuko0 sites60 target enrollmentJuly 30, 2020
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Bitoh Yuko
- Enrollment
- 60
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Selection criteria Observation only
- •A person who has a tracheotomy or laryngotracheal separation
- •Persons over 3 years old upon obtaining consent
- •A person who has obtained the written consent of the person or his or her proxy for their participation in this clinical study.
- •Person with good general condition (Fever of 38 degrees or more does not last for more than 48 hours, WBC\<12000 or CRP\<2\.0, etc. will be judged by the attending physician)
- •Airway disease ; Including cerebral palsy ,upper airway obstruction ,laryngeal stenosis, tracheal stenosis, and tracheomalacia ,etc.
- •Selection criterion Intervention with study drug
- •Those who can orally administer the test drug in Selection Criteria Observation only
Exclusion Criteria
- •1\. Those who have undergone tracheotomy or laryngeal trachea within 6 months prior to obtaining consent
- •2\. Those who received antibiotics within one month before obtaining consent
- •3\. Persons with severe liver and renal dysfunction
- •4\. Anyone who is allergic to drugs such as allergies or dairy products
- •5\. Pregnant women and patients who may be pregnant or breastfeeding
- •6\. Other persons who are judged inappropriate by the person in charge of this clinical study
Outcomes
Primary Outcomes
Not specified
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