Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03904758 |
| Other study ID # |
FNO-ENT-Pepsin |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2019 |
| Est. completion date |
December 31, 2021 |
Study information
| Verified date |
December 2022 |
| Source |
University Hospital Ostrava |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The diagnostics of extraesophageal reflux (EER) is challenging. Currently, 24-h dual-probe
esophageal pH monitoring or impedance is considered the best diagnostic method for EER. The
24-h oropharyngeal pH monitoring is a newer method aimed at detecting episodes of reflux to
the oropharynx. Unfortunately, all these methods have many disadvantages. Pepsin detection in
saliva would be an almost ideal diagnostic technique. However, data of its reliability is
lacking. The aim of the study is to compare results of oropharyngeal pH monitoring and
esophageal impedance monitoring, compared to a quantified pepsin presence in the saliva
obtained immediately prior to 24-hour monitoring and to evaluate the feasibility of this
technique as a routine option of diagnosing the presence of extraesophageal reflux.
Description:
Extraesophageal reflux (EER) has recently been found to be a risk factor for many head and
neck pathologies. Many studies have shown that contact between the refluxed content and
mucous tissue can cause local inflammation and edema and thus facilitate the development of
inflammation. Although important, the diagnostics of EER is not easy. The simplest means of
collecting information about reflux problems is questioning potential sufferers. However,
although many questionnaires have been developed over the last few years, questioning is
still not a suitable technique for the evaluation of EER, the reason being that symptoms of
EER are heterogeneous and very common. Currently, 24-h dual-probe esophageal pH monitoring or
impedance is considered the best diagnostic method for EER. The 24-h oropharyngeal pH
monitoring is a newer method aimed at detecting episodes of reflux to the oropharynx and
seems to generate similar results. However, these methods may not be tolerated well.
Moreover, the position of the sensor, which is placed in the hypopharynx or oropharynx, does
not precisely reflect the amount of reflux content that reaches larynx, nasopharynx, nasal
cavity or middle ear. Another disadvantage of pH monitoring is that it enables only a
short-term analysis over a timespan of just 24-48 h. Detection of pepsin in fluids and
tissues is considered by some authors to be perhaps more appropriate than pH monitoring
because it reflects the long-term effects of EER and proves that EER is truly affecting the
examined region. This is particularly true for more distant regions like the middle ear.
Pepsin detection in saliva would be very well tolerated and fast diagnostic method. However,
data of its reliability are lacking. The aim of the study is to compare results of
oropharyngeal pH monitoring and esophageal impedance monitoring, compared to a quantified
pepsin presence in the saliva obtained immediately prior to 24-hour monitoring and to
evaluate the feasibility of this diagnostic option as a routine method.
