Effect of Probiotic Nasal Irrigation on the Postoperative Care of Chronic Rhinosinusitis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTaichung Veterans General Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1. Patients with chronic rhinosinusitis who failed medical treatment 2. Patients underwent bilateral primary functional endoscopic sinus surgery.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
heat-killed probiotic LDL557 (Lactobacillus delbrueckii subsp. lactis LDL557)
Dietary supplementThe 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)
DrugNasal irrigation with 240 mL of warm saline solution twice daily for eight weeks, supplemented with 3 g of maltodextrin as a placebo
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: intervention armActive comparator 1 intervention
Group B: control armPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From before operation to 3 months after surgery2
Self-reported adverse events
Any adverse events occurring during the 2 months period of nasal irrigation
Time frame
From before nasal irrigation to after 2-month nasal irrigationSecondary outcomes
1
Change of endoscopic score
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.
Time frame
From before operation to 3 months after surgery2
Change of the second minimal cross-sectional area of the nasal cavity
The second minimal cross-sectional area of the nasal cavity was measured by acoustic rhinometry.
Time frame
From before operation to 3 months after surgery3
Change of saccharine transit time
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.
Time frame
From before operation to 3 months after surgerySponsors and contacts
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Source ClinicalTrials.gov
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