The effect of synbiotics on airway

Phase 4

Recruiting

• Conditions: After tracheotomy, after laryngotracheal separation; D014139

• Registration Number: JPRN-jRCTs051200039
• Lead Sponsor: Bitoh Yuko

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified