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Enrolling by Invitation

NCT Number: NCT07634614

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

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.

Enrolling by Invitation

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Spital Limmattal

Schlieren, Canton of Zurich, 8952, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Prof Urs Zingg

Other

Registry information

Acronym: LAS

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 9, 2026
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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