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Nasal microbe modulation to manage chronic inflammatory conditions of the nose and paranasal sinuses

The effect of modulation of the nasal microbiome in managing chronic inflammatory conditions of the nose and paranasal sinuses

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/02/040464
Enrollment
90
Registered
2022-02-21
Start date
Unknown
Completion date
Unknown
Last updated
2022-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J328- Other chronic sinusitis

Interventions

Intervention1: NasoBiome - Composition of the nasal spray: mixture of prebiotics and postbiotics in normal saline. The composition comprises Zymosan A, Laminarin, Cellulose, Lactose N fucopentose, Cel

Sponsors

AIIMS Bhubaneswar
Lead Sponsor
Government of Odisha Science and Technology Department
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Adults (more than 18 years); Diagnosis of CRS based on American Academy of Otolaryngology-Head Neck Surgery guidelines, refractory CRS, Atrophic Rhinitis based on clinical examination

Exclusion criteria

Exclusion criteria: Pregnancy, comorbidities that preclude travel for follow up, declining to be included in the study, a SNOT22 score of less than 10, LM score of less than 4 in cases of CRS.

Design outcomes

Primary

MeasureTime frame
1. Microbiome profile of patients with chronic inflammatory diseases of the nose and PNS 2. Improved quality of life of patients with chronic inflammation of the nose and PNS (in CRS and Atrophic Rhinitis)Timepoint: 3 years

Secondary

MeasureTime frame
1. Normal nasal microbiome profile across age and gender 2. The CT scan picture of the patients with the disease and following intervention 3. The histopathological changes following intervention in Chronic inflammatory diseases 4. To assess the change in the microbiome in these patients following intervention Timepoint: 3 years

Countries

India

Contacts

Public ContactSAURAV SARKAR

All India Institute of Medical Sciences, Bhubaneswar

biochem_ramadass@aiimsbhubaneswar.edu.in8547805341

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026