The effect of synbiotics on airway

JRCT ID: jRCTs051200039

Registered date:30/07/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: After tracheotomy, after laryngotracheal separation
• Date of first enrollment: 30/07/2020
• Target sample size: 60
• Study type: Interventional

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 Outcome

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 Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 3age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Bitoh Yuko
• Source(s) of Monetary Support: SHINRYOKUKAI INSTITUTE,JAPAN SOCIETY FOR THE PROMOTION OF SCIENCE