Sinusitis ChronicprobioticNCT07865715
Effect of Probiotic Nasal Irrigation on the Postoperative Care of Chronic Rhinosinusitis
A study testing heat-killed probiotic LDL557 (Lactobacillus delbrueckii subsp. lactis LDL557) and Normal Saline (NS) in people with Sinusitis Chronic and Postoperative Care, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sinusitis Chronic, Postoperative Care
- What is being tested?
- heat-killed probiotic LDL557 (Lactobacillus delbrueckii subsp. lactis LDL557) and Normal Saline (NS)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 31 Oct 2026to 28 Feb 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Patients with chronic rhinosinusitis who failed medical treatment 2. Patients underwent bilateral primary functional endoscopic sinus surgery.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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.
- Conditions
- Sinusitis Chronic, Postoperative Care
- Being tested
- heat-killed probiotic LDL557 (Lactobacillus delbrueckii subsp. lactis LDL557), Normal Saline (NS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| intervention arm | Active comparator | probiotic Receives: Dietary Supplement: heat-killed probiotic LDL557 (Lactobacillus delbrueckii subsp. lactis LDL557) |
| control arm | Placebo comparator | normal saline Receives: Drug: Normal Saline (NS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From before operation to 3 months after surgery
Self-reported adverse events
Any adverse events occurring during the 2 months period of nasal irrigation
Measured: From before nasal irrigation to after 2-month nasal irrigation
Secondary outcomes (3)
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.
Measured: From before operation to 3 months after surgery
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.
Measured: From before operation to 3 months after surgery
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.
Measured: From before operation to 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study start31 Oct 2026 (estimated)
- Primary completion31 Oct 2028 (estimated)
- Study completion28 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sinusitis ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rong-San Jiang, Taichung Veterans General Hospital
- Investigators
- Rong-San Jiang, MD, PhD, Principal investigator, Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07865715
- Sponsor's protocol ID
- CF26391C
- Acronym
- probiotic
- Status last verified
- Jul 2026
- First submitted
- 3 Oct 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Outcome measures