Method of Early Diagnosis of Laryngopharyngeal Reflux (LPR)

• ClinicalTrials.gov Identifier: NCT04771221
• Recruitment Status: Enrolling by invitation
• First Posted: February 25, 2021
• Last Update Posted: November 30, 2021
• Sponsor: Kazakh Medical University of Continuing Education
• Information provided by (Responsible Party): Kazakh Medical University of Continuing Education

Study Description

Brief Summary:

The investigator will issue a Patient Information Consent for the participant in the study. 1.Patients will be asked to complete the Reflux Symptom Index questionnaire.

Clinical survey, medical history 2. Objective methods for assessing the patient's condition:

- examination of ENT organs: rhinoscopy, otoscopy, pharyngoscopy and laryngoscopy 3. Laboratory and instrumental research methods - Endoscopic laryngoscopy and video laryngoscopy. pH-metry: The collection of mucus from the laryngopharynx for the determination of acid-base values.

4.Sociological method: determination of lifestyle, nutrition, the presence or absence of bad habits.

5. Subjective methods for assessing the condition of the larynx - Questionnaires.

6. Аnalysis of the received data

Condition or disease	Intervention/treatment	Phase
Laryngopharyngeal Reflux; Laryngopharyngitis Chronic; Gastro Esophageal Reflux; Laryngitis	Diagnostic Test: pH metry; Diagnostic Test: Filling out the questionnaire; Device: Endoscopic laryngoscopy	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 300 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Method of Early Diagnosis of Laryngopharyngeal Reflux in an Outpatient Appointment of an Otorhinolaryngologist
• Actual Study Start Date: January 10, 2021
• Estimated Primary Completion Date: December 30, 2021
• Estimated Study Completion Date: April 1, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Main group; Patients with complaints of sore throat, coughing, burning sensation in the throat, cough, frequent sore throat, difficulty swallowing, lump in the throat, feeling of a foreign body in the throat, voice change, heartburn, belching.	Diagnostic Test: pH metry; The collection of mucus from the laryngopharynx to determine the acid-base values through pH-metry.; Diagnostic Test: Filling out the questionnaire; Completion of the questionnaire index of reflux symptoms. An analysis of the results of the effectiveness of this method in patients with complaints of sore throat, coughing, burning sensation in the throat, cough, frequent sore throat, difficulty swallowing, lump in the throat, feeling of a foreign body in the throat, voice change, heartburn, belching will be carried out. Evaluation results range from 0 to 5, where 0 is an indicator of no problem, and 5 is an indicator of a serious problem; Device: Endoscopic laryngoscopy; Video laryngoscopy and assessment of the presence / severity of the symptoms. Evaluation results range from 0 to 4, where 0 is an indicator of no problem, and 4 is an indicator of a serious problem
Experimental: Control group 1; Patients with an early diagnosis of Gastroesophageal reflux disease	Diagnostic Test: pH metry; The collection of mucus from the laryngopharynx to determine the acid-base values through pH-metry.; Diagnostic Test: Filling out the questionnaire; Completion of the questionnaire index of reflux symptoms. An analysis of the results of the effectiveness of this method in patients with complaints of sore throat, coughing, burning sensation in the throat, cough, frequent sore throat, difficulty swallowing, lump in the throat, feeling of a foreign body in the throat, voice change, heartburn, belching will be carried out. Evaluation results range from 0 to 5, where 0 is an indicator of no problem, and 5 is an indicator of a serious problem; Device: Endoscopic laryngoscopy; Video laryngoscopy and assessment of the presence / severity of the symptoms. Evaluation results range from 0 to 4, where 0 is an indicator of no problem, and 4 is an indicator of a serious problem
Experimental: Control group 2; Patients without complaints of sore throat, coughing, burning sensation in the throat, cough, frequent sore throat, difficulty swallowing, lump in the throat, feeling of a foreign body in the throat, voice change, heartburn, belching.	Diagnostic Test: pH metry; The collection of mucus from the laryngopharynx to determine the acid-base values through pH-metry.; Diagnostic Test: Filling out the questionnaire; Completion of the questionnaire index of reflux symptoms. An analysis of the results of the effectiveness of this method in patients with complaints of sore throat, coughing, burning sensation in the throat, cough, frequent sore throat, difficulty swallowing, lump in the throat, feeling of a foreign body in the throat, voice change, heartburn, belching will be carried out. Evaluation results range from 0 to 5, where 0 is an indicator of no problem, and 5 is an indicator of a serious problem; Device: Endoscopic laryngoscopy; Video laryngoscopy and assessment of the presence / severity of the symptoms. Evaluation results range from 0 to 4, where 0 is an indicator of no problem, and 4 is an indicator of a serious problem

Outcome Measures

Primary Outcome Measures :

1. Acidity level of the main group, Week 0 [ Time Frame: at the inclusion to the study ]
   The acidity level of the larynx is assessed using litmus paper. The range of acidity levels is from 4.5 to 9.0, where below 7.0 indicates the acidity of the environment, above 7.5 - alkalinity.
2. Acidity level of the control group 1, Week 0 [ Time Frame: at the inclusion to the study ]
   The acidity level of the larynx is assessed using litmus paper. The range of acidity levels is from 4.5 to 9.0, where below 7.0 indicates the acidity of the environment, above 7.5 - alkalinity.
3. Acidity level of the control group 2, Week 0 [ Time Frame: at the inclusion to the study ]
   The acidity level of the larynx is assessed using litmus paper. The range of acidity levels is from 4.5 to 9.0, where below 7.0 indicates the acidity of the environment, above 7.5 - alkalinity.
4. "Index of reflux symptoms" of the main group, Week 0 [ Time Frame: at the inclusion to the study ]
   Patients will be asked to complete the Reflux Symptom Index questionnaire. An analysis of the results of the effectiveness of this method in patients with complaints of sore throat, coughing, burning sensation in the throat, cough, frequent sore throat, difficulty swallowing, lump in the throat, feeling of a foreign body in the throat, voice change, heartburn, belching will be carried out. The severity of the problem is calculated as the summation of all points. The problem is absent if the summation of points is 0. The problem is serious if the summation of points is 5.
5. "Index of reflux symptoms" of the control group 1, Week 0 [ Time Frame: at the inclusion to the study ]
   Patients will be asked to complete the Reflux Symptom Index questionnaire. An analysis of the results of the effectiveness of this method in patients with complaints of sore throat, coughing, burning sensation in the throat, cough, frequent sore throat, difficulty swallowing, lump in the throat, feeling of a foreign body in the throat, voice change, heartburn, belching will be carried out. The severity of the problem is calculated as the summation of all points. The problem is absent if the summation of points is 0. The problem is serious if the summation of points is 5.
6. "Index of reflux symptoms" of the control group 2, Week 0 [ Time Frame: at the inclusion to the study ]
   Patients will be asked to complete the Reflux Symptom Index questionnaire. An analysis of the results of the effectiveness of this method in patients with complaints of sore throat, coughing, burning sensation in the throat, cough, frequent sore throat, difficulty swallowing, lump in the throat, feeling of a foreign body in the throat, voice change, heartburn, belching will be carried out. The severity of the problem is calculated as the summation of all points. The problem is absent if the summation of points is 0. The problem is serious if the summation of points is 5.
7. Endoscopic laryngoscopy of the main group, Week 0 [ Time Frame: at the inclusion to the study ]
   Assessment of the state of the larynx on the scale of reflux symptoms. Where the presence and severity of the sign is assessed in points from 0 to 4. Where 0 is an indicator of no problem, and 4 is an indicator of a serious problem.
8. Endoscopic laryngoscopy of the control group 1, Week 0 [ Time Frame: at the inclusion to the study ]
   Assessment of the state of the larynx on the scale of reflux symptoms. Where the presence and severity of the sign is assessed in points from 0 to 4. Where 0 is an indicator of no problem, and 4 is an indicator of a serious problem.
9. Endoscopic laryngoscopy of the control group 2, Week 0 [ Time Frame: at the inclusion to the study ]
   Assessment of the state of the larynx on the scale of reflux symptoms. Where the presence and severity of the sign is assessed in points from 0 to 4. Where 0 is an indicator of no problem, and 4 is an indicator of a serious problem.

Secondary Outcome Measures :

1. Acidity level of the main group, Week 2 [ Time Frame: at 2 weeks after initial treatment ]
   The acidity level of the larynx is assessed using litmus paper. The range of acidity levels is from 4.5 to 9.0, where above 7.5 indicates the alkalinity of the medium, below 7.0 - acidic.
2. Acidity level of the control group 1, Week 2 [ Time Frame: at 2 weeks after initial treatment ]
   The acidity level of the larynx is assessed using litmus paper. The range of acidity levels is from 4.5 to 9.0, where above 7.5 indicates the alkalinity of the medium, below 7.0 - acidic.
3. Acidity level of the control group 2, Week 2 [ Time Frame: at 2 weeks after initial treatment ]
   The acidity level of the larynx is assessed using litmus paper. The range of acidity levels is from 4.5 to 9.0, where above 7.5 indicates the alkalinity of the medium, below 7.0 - acidic.
4. "Index of reflux symptoms" of the main group, Week 2 [ Time Frame: at 2 weeks after initial treatment ]
   Patients will be asked to complete the Reflux Symptom Index questionnaire. An analysis of the results of the effectiveness of this method in patients with complaints of sore throat, coughing, burning sensation in the throat, cough, frequent sore throat, difficulty swallowing, lump in the throat, feeling of a foreign body in the throat, voice change, heartburn, belching will be carried out. The severity of the problem is calculated as the summation of all points. The problem is absent if the summation of points is 0. The problem is serious if the summation of points is 5.
5. "Index of reflux symptoms" of the control group 1, Week 2 [ Time Frame: at 2 weeks after initial treatment ]
   Patients will be asked to complete the Reflux Symptom Index questionnaire. An analysis of the results of the effectiveness of this method in patients with complaints of sore throat, coughing, burning sensation in the throat, cough, frequent sore throat, difficulty swallowing, lump in the throat, feeling of a foreign body in the throat, voice change, heartburn, belching will be carried out. The severity of the problem is calculated as the summation of all points. The problem is absent if the summation of points is 0. The problem is serious if the summation of points is 5.
6. "Index of reflux symptoms" of the control group 2, Week 2 [ Time Frame: at 2 weeks after initial treatment ]
   Patients will be asked to complete the Reflux Symptom Index questionnaire. An analysis of the results of the effectiveness of this method in patients with complaints of sore throat, coughing, burning sensation in the throat, cough, frequent sore throat, difficulty swallowing, lump in the throat, feeling of a foreign body in the throat, voice change, heartburn, belching will be carried out. The severity of the problem is calculated as the summation of all points. The problem is absent if the summation of points is 0. The problem is serious if the summation of points is 5.
7. Endoscopic laryngoscopy of the main group, Week 2 [ Time Frame: at 2 weeks after initial treatment ]
   Assessment of the state of the larynx on the scale of reflux symptoms. Where the presence and severity of the sign is assessed in points from 0 to 4. Where 0 is an indicator of no problem, and 4 is an indicator of a serious problem.
8. Endoscopic laryngoscopy of the control group 1, Week 2 [ Time Frame: at 2 weeks after initial treatment ]
   Assessment of the state of the larynx on the scale of reflux symptoms. Where the presence and severity of the sign is assessed in points from 0 to 4. Where 0 is an indicator of no problem, and 4 is an indicator of a serious problem.
9. Endoscopic laryngoscopy of the control group 2, Week 2 [ Time Frame: at 2 weeks after initial treatment ]
   Assessment of the state of the larynx on the scale of reflux symptoms. Where the presence and severity of the sign is assessed in points from 0 to 4. Where 0 is an indicator of no problem, and 4 is an indicator of a serious problem.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 59 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Patient's informed consent
• Age: 18-59 years old
• No serious somatic diseases.
• Patients with complaints of sore throat, coughing, burning sensation in the throat, coughing, frequent sore throat, difficulty swallowing, lump in the throat, foreign body feeling in the throat, voice changes, heartburn and belching.
• Diagnosis: Chronic pharyngitis
• Chronic laryngitis

Exclusion Criteria:

• Disagreement to participate in scientific research
• Age: under 18 and over 60
• Severe somatic diseases, organic lesions of the gastrointestinal tract and ENT organs
• Patients with pulmonary pathologies
• Patients with allergic manifestations (seasonal hay fever, asthma, etc.)
• With diagnoses: Acute respiratory diseases
• Patients with general neuralgic disorders

Contacts and Locations

Locations

Kazakhstan

SOS Medical Assistance

Almaty, Kazakhstan

V-ent

Almaty, Kazakhstan

Sponsors and Collaborators

Kazakh Medical University of Continuing Education

Investigators

• Principal Investigator: Nukusbekova; Doctor

More Information

• Responsible Party: Kazakh Medical University of Continuing Education
• ClinicalTrials.gov Identifier: NCT04771221
• Other Study ID Numbers: 14-2020; 14-2020 ( Other Identifier: KazMUCE )
• First Posted: February 25, 2021
• Last Update Posted: November 30, 2021
• Last Verified: November 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kazakh Medical University of Continuing Education:

Laryngopharyngeal Reflux; Laryngopharyngitis Chronic; Gastro Esophageal Reflux; Laryngitis; pH monitoring; pH metric

Additional relevant MeSH terms:

Laryngitis; Gastroesophageal Reflux; Laryngopharyngeal Reflux; Croup; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Infections; Infections; Otorhinolaryngologic Diseases