After tracheotomy, after laryngotracheal separation After tracheotomy, after laryngotracheal separation
Conditions
Interventions
Synprotec
1.0 g of food containing lactic acid bacteria and bifidobacterial live bacteria
Oligosaccharide food 1 package 6.8g
After meals, one package once for 1 to 3 times daily for 8 weeks.
synbiotic
Sponsors
Bitoh Yuko
Eligibility
Sex/Gender
All
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Exam 1 Bacterial flora in the lower respiratory tract before administration of synbiotics Exam 2 Change in Bifidobacterium bacteria amount after 8 weeks, based on baseline before administration of synbiotics | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in other flora in the lower respiratory tract Oral bacterial flora / faecal flora / blood flora Prevention of pneumonia Defecation status Lower respiratory tract / oral / intestinal environment | — |
Contacts
Public ContactYuichiro Tomioka
Kobe University Hospital
Outcome results
None listed