Pre- and Post-Therapy Evaluation of Air-Associated Symptoms in Patients With Gastro-esophageal Reflux Disease (GERD): Assessing the Role of Speech and Language Therapy

Status

Enrolling by invitation

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07634614

Acronym

LAS

Enrollment

100

Registered

2026-06-09

Start date

2026-04-21

Completion date

2027-12-31

Last updated

2026-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

GERD

Brief summary

Patients with gastroesophageal reflux disease (GERD) may present with concomitant gas-related symptom (GRS) such as supragastric or gastric belching, and aerophagia. Identifying these patients is crucial, as their therapeutic pathway differs substantially from that of patients with "pure" reflux disease. Proceeding directly to antireflux surgery in the presence of untreated air-associated symptoms can lead to catastrophic postoperative outcomes. These partly behavioral disorders can often be effectively managed through targeted speech therapy. Following successful therapy, patients may either experience complete resolution of their symptoms or become suitable candidates for surgical treatment of GERD. As of today, there is very scarce literature on this subject.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age 18 years and older * Initial presentation at our reflux center with reflux symptoms, with or without concomitant air-related symptoms such as belching, bloating, or abdominal distension * Confirmed air-related pathology based on characteristic clinical findings and/or diagnostic evidence from impedance, manometry, or videofluoroscopic swallow study (VFSS) * Verbal informed consent as documented by the investigator

Exclusion criteria

* Age under 18 years * Pregnancy * Exclusion of GERD * Preoperative presence of a hiatal hernia with migration of \>20% of stomach in the chest * Revisional surgery (after other procedures for reflux or at the hiatus)

Design outcomes

Primary

Measure	Time frame	Description
Comparison of air-associated symptoms and their impact on daily life before and after targeted speech and language therapy in patients with GERD, assessed using a specifically developed patient questionnaire.	From start of speech therapy until interview: - Speech therapy was started earliest in January 2023, latest around January 2026. - Interviews are taking place starting in April 2026 until all have been performed, end is anticipated in fall 2026.	Comparison of air-associated symptoms and their impact on daily life before and after targeted speech and language therapy in patients with GERD.

Countries

Switzerland

Contacts

PRINCIPAL_INVESTIGATORUrs Zingg, Prof. Dr. med-

Spital Limmattal Schlieren

Outcome results