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probiotic
Sponsor study identifier
interventional
120
1 country
1
Study Start
October 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
October 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
February 28, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Chronic rhinosinusitis is a common chronic disease in otolaryngology, with a prevalence of approximately 20% in Taiwan. Patients often experience symptoms such as nasal congestion, runny nose, postnasal drip, and olfactory abnormalities, significantly impacting their quality of life. When drug treatment is ineffective, patients may require functional endoscopic sinus surgery to improve symptoms. However, proper postoperative care is often a crucial factor in the success of the surgery. Nasal irrigation is widely used to treat nasal and sinus diseases, with saline solution being the most commonly used irrigation fluid. However, recent studies have indicated that the nasal microbiome may be related to the inflammatory response in chronic rhinosinusitis; therefore, the application of probiotics as nasal irrigation additives has gradually attracted attention. Some studies suggest that certain probiotics may have the potential to regulate local immune responses and reduce inflammation. This study employs a prospective, randomized comparative study design. This study aims to enroll 120 patients undergoing functional endoscopic sinus surgery for chronic rhinosinusitis. One month post-surgery, patients will be randomly assigned to two groups: Group 1 (saline nasal irrigation group): Nasal irrigation with 240 mL of warm saline solution twice daily for eight weeks, supplemented with 3 g of maltodextrin as a placebo. Group 2 (probiotic nasal irrigation group): Nasal irrigation with 240 mL of warm saline solution containing 3 g of probiotic heat-killed probiotic LDL557 twice daily for eight weeks (concentration 10\^8 cfu/mL). The heat-killed probiotic LDL557 (Lactobacillus delbrueckii subsp. lactis LDL557) used in this study is a lactic acid bacteria strain screened from corn and developed by Taiwan Synbio Tech Co., Ltd. Two groups of subjects underwent questionnaire assessments, nasal endoscopy, olfactory testing, nasal function testing, nasal bacterial culture, and measurement of inflammatory markers of nasal irrigation fluid before and after nasal irrigation. This study aims to further evaluate the potential clinical benefits of probiotic nasal irrigation in the postoperative care of chronic rhinosinusitis, serving as a reference for future postoperative care models for chronic rhinosinusitis.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 28, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 3, 2026
Actual (reported)October 8, 2026
Actual (reported)October 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
October 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
February 28, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Taiwanese version of the 22-item Sino-Nasal Outcome Test
The Taiwanese version of the 22-item Sino-Nasal Outcome Test contains 22 items of symptoms and social/emotional consequences from nasal disorder. Patients are asked to rate their problems based on how they have been over the past two weeks. Each item is graded from 0 (no problem) to 5 (as bad as it can be) according to its severity and frequency.
From before operation to 3 months after surgery
Self-reported adverse events
Any adverse events occurring during the 2 months period of nasal irrigation
From before nasal irrigation to after 2-month nasal irrigation
Change of endoscopic score
From before operation to 3 months after surgery
Change of the second minimal cross-sectional area of the nasal cavity
From before operation to 3 months after surgery
Change of saccharine transit time
From before operation to 3 months after surgery
probiotic
normal saline
The heat-killed probiotic LDL557 (Lactobacillus delbrueckii subsp. lactis LDL557) used in this study is a lactic acid bacteria strain screened from corn and developed by Taiwan Synbio Tech Co., Ltd. Nasal irrigation with 240 mL of warm saline solution containing 3 g of probiotic heat-killed probiotic LDL557 twice daily for eight weeks (concentration 10\^8 cfu/mL)
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
Rong-San Jiang, MD, PhD
Taichung Veterans General Hospital
First Submitted
October 3, 2026
First Posted
October 8, 2026
Study Start
October 31, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
Nasal irrigation with 240 mL of warm saline solution twice daily for eight weeks, supplemented with 3 g of maltodextrin as a placebo
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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October 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
February 28, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 8, 2026
Record last verified: 2026-07
Outcome measures
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Source: ClinicalTrials.gov.
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