Phase 4 Chronic Rhinosinusitis Trial, Completed NCT00396162 Sponsor: University of Michigan Condition: Chronic Rhinosinusitis
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Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial involved 77 people in total — 39 in the probiotic group and 38 in the placebo (dummy pill) group. The trial ran for eight weeks and was measuring nasal and sinus symptoms using a tool called the SNOT-20, which is a questionnaire where a score of 0 means no symptoms and 100 means the worst possible symptoms. The trial also tracked side effects, antibiotic use, and steroid nasal spray use during the eight weeks. The reported data shows that, on average, people in the probiotic group had a reduction of 1.8 points in their SNOT-20 symptom score over the eight weeks, while people in the placebo group had a reduction of 5.5 points. For side effects, 14 participants in the probiotic group and 17 in the placebo group reported at least one side effect. Regarding antibiotic use, the placebo group used antibiotics for an average of 1.9 days, compared to 0.8 days in the probiotic group. For steroid nasal spray use, the probiotic group averaged 2.8 days of use, while the placebo group averaged 0.4 days. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 4 Chronic Rhinosinusitis Trial, Completed

NCT00396162
Completed Phase 4

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are between 15 and 70 years old.
  • You have had a blocked nose on more than half of days over the last 3 months, lasting at least 12 weeks in a row.
  • You have had a runny nose on more than half of days over the last 3 months, lasting at least 12 weeks in a row.
  • An ear, nose, and throat (ENT) specialist has diagnosed you with chronic inflammatory rhinosinusitis (long-term swelling in the nose and sinuses, with thickened nasal lining or nasal polyps, and no active bacterial infection).
  • You have access to a telephone, either at home or a personal mobile phone.

Who may not be able to join:

  • You have had sinus surgery within the last 3 months.
  • You have had an illness in the last 2 weeks that required antibiotics, such as an ear infection, sore throat, bronchitis, or laryngitis.
  • You have a weakened immune system, whether due to medications (such as steroid tablets), or conditions such as autoimmune disease, HIV, cystic fibrosis, uncontrolled diabetes, chronic kidney failure, or cancer (confirm with trial site).
  • You have been diagnosed with a bacterial sinus infection, either ongoing or recent.
  • You have had an allergic reaction to a probiotic supplement in the past, such as chest tightness, difficulty breathing, hives, or a rash.
  • You are unable to speak or read English.
  • You are currently pregnant or breastfeeding.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

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Trial details

Status
Completed
Phase
Phase 4
Registry
ClinicalTrials.gov
Start date
1 November 2006
Est. completion
1 January 2008

Primary endpoints

Mean Reduction in SNOT-20 Scores

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov