Effect of Probiotic Nasal Irrigation on the Postoperative Care of Chronic Rhinosinusitis

NCT07865715 — Not applicable, Not yet recruiting, 120 participants, Taichung Veterans General Hospital

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Registry	NCT07865715, acronym probiotic
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: quadruple, supportive care
Enrollment	120 (Estimated)
Sponsor	Taichung Veterans General Hospital (Other)
Conditions	Sinusitis Chronic, Postoperative Care
Interventions	heat-killed probiotic LDL557 (Lactobacillus delbrueckii subsp. lactis LDL557), Normal Saline (NS) (Dietary supplement, drug)
Dates	start 2026-10-31 (estimated), primary completion 2028-10-31 (estimated), completion 2029-02-28 (estimated), first posted 2026-10-08, last updated 2026-10-08
Locations	1 site in Taiwan

-Summary

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.

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+Arms and interventions

Arm	Type	Interventions	Description
intervention arm	Active comparator	Dietary Supplement: heat-killed probiotic LDL557 (Lactobacillus delbrueckii subsp. lactis LDL557)	probiotic
control arm	Placebo comparator	Drug: Normal Saline (NS)	normal saline

heat-killed probiotic LDL557 (Lactobacillus delbrueckii subsp. lactis LDL557) (Dietary supplement): 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)
Normal Saline (NS) (Drug): Nasal irrigation with 240 mL of warm saline solution twice daily for eight weeks, supplemented with 3 g of maltodextrin as a placebo

+Outcome measures

Primary outcomes

Taiwanese version of the 22-item Sino-Nasal Outcome Test [From before operation to 3 months after surgery]: 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.
Self-reported adverse events [From before nasal irrigation to after 2-month nasal irrigation]: Any adverse events occurring during the 2 months period of nasal irrigation

Secondary outcomes

Change of endoscopic score [From before operation to 3 months after surgery]: The endoscopic appearances were categorized into polyps (0: no polyps; 1: polyps present within the middle meatus; 2: polyps beyond the middle meatus); nasal secretion (0: no secretion; 1: clear, thin secretion; 2: thick, purulent secretion); mucosal edema; scarring; crusting; (0: absent; 1: mild; 2: severe). The score ranged from 0 to 20 for both nostrils together.
Change of the second minimal cross-sectional area of the nasal cavity [From before operation to 3 months after surgery]: The second minimal cross-sectional area of the nasal cavity was measured by acoustic rhinometry.
Change of saccharine transit time [From before operation to 3 months after surgery]: The saccharine transit test involved placing saccharine granules under the head of the inferior turbinate in the more severely affected nostril. The time interval (minute) between placement of saccharine granules and sensation of sweetness in the throat was recorded.

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* 1\. Patients with chronic rhinosinusitis who failed medical treatment 2. Patients underwent bilateral primary functional endoscopic sinus surgery.

Exclusion Criteria:

* 1\. Patients with a history of immunodeficiency 2. Patients with a history of sinus surgery 3. Patients who receiving antibiotic treatment within a week before functional endoscopic sinus surgery 4. Patients with a pathological diagnosis of fungal sinusitis 5. Patients with a pathological diagnosis of sinonasal tumor

+Locations (1)

Facility	City	Country	Status
Taichung Veterans General Hospital	Taichung	Taiwan

+Investigators

Rong-San Jiang, MD, PhD, Principal investigator, Taichung Veterans General Hospital