Gastro-oesophageal Reflux Disease Trial, Recruiting NCT06348420 Sponsor: Qilu Hospital of Shandong University Condition: Gastro-oesophageal Reflux Disease
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Gastro-oesophageal Reflux Disease Trial, Recruiting

NCT06348420
Recruiting Not Applicable

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:

  • People aged between 18 and 60 years old
  • People who have a small hiatal hernia (a condition where part of the stomach slides into the chest) of 2 cm or less
  • People whose hernia is the "sliding" type and measures 2 cm or less
  • People whose acid reflux (GERD) symptoms come back after they stop taking their acid-blocking medication (PPIs)
  • People who have been taking an acid-blocking medication (PPI) once a day for at least 1 year, or twice a day for at least 8 weeks
  • People with moderate to severe inflammation of the food pipe (graded B, C, or D on a standard medical scale)
  • People whose stomach valve flap (a structure at the top of the stomach) is rated at grade III or lower on a standard scale
  • People whose food pipe shows excess acid (pH below 4) on at least 1–2 days within a 7-day monitoring period, above a specific threshold
  • People with normal or near-normal movement and function of the food pipe
  • People whose lower food pipe muscle pressure falls within a specific range (5–15 mmHg)
  • People whose acid reflux measurements meet a specific severity score (DeMeester score of 14.7 or higher, or more than 73 reflux episodes recorded)
  • People who have signed a consent form agreeing to take part in the trial

Who may not be able to join:

  • People with a BMI (body mass index) over 35
  • People with significant overall health concerns rated above a certain medical fitness level (confirm with trial site)
  • People who have Barrett's oesophagus (a condition where the lining of the food pipe has changed)
  • People whose hiatal hernia is larger than 2 cm
  • People with only mild or no inflammation of the food pipe (Grade A or none on the standard scale)
  • People whose stomach valve flap is rated above grade III on the standard scale
  • People who have peptic ulcers (sores in the stomach or upper digestive tract)
  • People who have a condition affecting food pipe movement, such as achalasia
  • People with severe gastroparesis (a condition where the stomach empties very slowly)
  • People who have previously had surgery on the stomach or food pipe, including certain specific procedures (confirm with trial site)
  • People with serious ongoing health conditions that are not well controlled
  • People who have a blockage at the outlet of the stomach
  • People who are pregnant or planning to become pregnant

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
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Phone: 18560089069

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Qilu Hospital of Shandong University
Registry
ClinicalTrials.gov
Start date
10 September 2024
Est. completion
1 December 2025

Where this trial is recruiting

🇨🇳 China

Primary endpoints

GERD-HRQL

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