NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs051200039

Registered date:30/07/2020

The effect of synbiotics on airway

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedAfter tracheotomy, after laryngotracheal separation
Date of first enrollment12/02/2021
Target sample size60
Countries of recruitment
Study typeInterventional
Intervention(s)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.

Outcome(s)

Primary OutcomeExam 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 OutcomeChanges 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

Key inclusion & exclusion criteria

Age minimum>= 3age old
Age maximumNot applicable
GenderBoth
Include criteriaSelection 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
Exclude criteria1. 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

Related Information

Contact

Public contact
Name Yuichiro Tomioka
Address 7-5-2 Kusunoki-cho,chuuou-ku,kobe,JAPAN Hyogo Japan 650-0017
Telephone +81-78-382-5942
E-mail tomyking9821@gmail.com
Affiliation Kobe University Hospital
Scientific contact
Name Yuko Bitoh
Address 7-5-2 Kusunoki-cho,chuuou-ku,kobe,JAPAN Hyogo Japan 650-0017
Telephone +81-78-382-5942
E-mail byuko1023@gmail.com
Affiliation Kobe University Hospital