The Effect of Synbiotics on the Upper Respiratory Tract Infection

Huazhong University of Science and Technology

Status: Completed

Conditions: Gut Microbiota; Immune Function; Upper Respiratory Tract Infection

Treatments: Dietary Supplement: Synbiotic; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04960878

2020S042

Details and patient eligibility

About

Gut microbiome manipulation to alter the gut-lung axis may potentially protect humans against respiratory infections. However, clinical trials of synbiotics, one of the microbiota-targeted intervention, in this regard is few. Therefore, this study aims to examine the effect of synbiotics on the incidence and severity of upper respiratory tract infection, gut microbiota composition and function, as well as biomarkers of immune function.

Enrollment: 58 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• aged 18-65 years；
• good general health as determined by medical questionnaires;
• BMI <35 kg/m2;

Exclusion criteria

• known congenital or acquired immune defects；
• allergies and other chronic or acute diseases requiring treatment；
• subjects with chronic gastrointestinal diseases;
• alcohol or drug misuse or both；
• pregnancy or lactation；
• vaccination against influenza within the last 12 months；
• use of oral antibiotics, probiotics, prebiotics, synbiotics, drugs active on gastrointestinal motility, or a laxative of any class within the last month.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

58 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

1.5 g maltodextrin in a sachet once daily for 8 weeks.

Treatment:

Dietary Supplement: Placebo

Synbiotic

Experimental group

Description:

1.5 g synbiotics supplement of Lactobacillus rhamnosus HN001 (1.5×10\^11 CFU) , Bifidobacterium lactis HN019 (7.5×10\^10 CFU), and 500mg fructooligosaccharides in a sachet once daily for 8 weeks.

Treatment:

Dietary Supplement: Synbiotic