# Omega-3-Based Nutraceutical Supplementation as Adjunctive Therapy in Adults With Otitis Media With Effusion: A Multicenter, Double-Blind, Randomized Placebo-Controlled Trial

> **NCT07721610** · PHASE4 · COMPLETED · sponsor: **Isola Tiberina - Gemelli Isola Hospital, Rome, Italy** · enrollment: 501 (actual)

## Conditions studied

- Otits Media With Effusion

## Interventions

- **DIETARY_SUPPLEMENT:** Omega-3-based nutraceutical combination (Otoair Flogo)
- **DRUG:** Bilastine 20 mg
- **DRUG:** Placebo Tablet or Capsule
- **DRUG:** Intranasal mometasone furoate spray
- **DRUG:** Oral deflazacort 30 mg

## Key facts

- **NCT ID:** NCT07721610
- **Lead sponsor:** Isola Tiberina - Gemelli Isola Hospital, Rome, Italy
- **Sponsor class:** OTHER
- **Phase:** PHASE4
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2025-10-01
- **Primary completion:** 2026-04-01
- **Final completion:** 2026-05-01
- **Target enrollment:** 501 (ACTUAL)
- **Last updated:** 2026-07-23


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT07721610

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT07721610, "Omega-3-Based Nutraceutical Supplementation as Adjunctive Therapy in Adults With Otitis Media With Effusion: A Multicenter, Double-Blind, Randomized Placebo-Controlled Trial". Retrieved via MORVS 2026-10-20 from https://api.morvs.ai/clinical/NCT07721610. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*