Fish oil cocktail takes on stubborn ear fluid in adults
NCT ID NCT07721610
First seen Jul 23, 2026 · Last updated Jul 24, 2026 · Updated 1 time
Summary
This trial tests whether a daily supplement containing omega-3s, Spirulina, magnesium, and vitamin B6 can help adults with persistent middle ear fluid — a condition that can cause hearing loss and ear fullness. Over 500 adults aged 18 to 70 with confirmed otitis media with effusion will receive the supplement, an antihistamine, or a placebo, all on top of standard anti-inflammatory treatment. The goal is to see if the supplement improves ear pressure and hearing more than the other options.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a nutraceutical combination of omega-3 fatty acids, Spirulina, magnesium, and vitamin B6
- What this could lead to
- If effective, this supplement could offer a well-tolerated option to help clear middle ear fluid and improve hearing in adults, reducing the need for more invasive treatments.
- What could go wrong
- This is a Phase 4 trial, but the supplement is tested as an add-on to standard therapy, so its standalone benefit is unclear. Results may not apply to all patients, and side effects from the supplement are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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501 people
The number who actually took part.
- Started
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Oct 2025
- Finished
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May 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age 18 to 70 years * Confirmed diagnosis of unilateral or bilateral otitis media with effusion (OME), established by otoscopic examination and tympanometry (type B curve) * Duration of symptoms of at least 4 weeks prior to enrollment * Ability to provide written informed consent * Willingness to comply with the study protocol and attend all scheduled visits Exclusion Criteria: Pregnancy or breastfeeding Uncontrolled asthma Chronic obstructive or restrictive pulmonary disease Autoimmune or connective tissue disease Acute sinusitis or acute upper respiratory tract infection at the time of enrollment Cardiovascular, hepatic, or renal disease Use of medications known to affect immune response History of nasal or sinus surgery Receipt of immunotherapy within 3 years prior to enrollment or planned immunotherapy during the study period Any other condition that, in the investigator's judgement, would preclude safe participation or compromise the integrity of the trial
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Isola Tiberina - Gemelli Isola Hospital Rome, Italy
Roma, Italy, 00100, Italy