Gastro-oesophageal Reflux Disease Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed with gastroesophageal reflux disease (acid reflux), with typical symptoms such as heartburn and/or regurgitation lasting at least 6 months before the screening visit, as confirmed by the investigator
• People who have had a camera test of the upper digestive tract (endoscopy) within the last 6 months that ruled out erosive reflux disease, Barrett's oesophagus, and other abnormalities of the oesophagus
• People who have not used certain medications in the period leading up to screening — including acid-reducing medicines (such as proton pump inhibitors or H2 blockers), certain gut motility medicines, certain antidepressants, antibiotics, or stomach-coating medicines — within the timeframes specified by the trial (confirm with trial site for exact details)
• People whose acid reflux symptoms are noticeably affecting their quality of life, as reported by the patient and confirmed by the investigator
• People aged 18 or older at the time of screening
• Women who are not pregnant (confirmed by a negative urine pregnancy test), not breastfeeding, and either using a highly effective form of contraception or meeting the definition of non-childbearing potential (such as being surgically sterile, physiologically unable to become pregnant, or at least 12 months past menopause)
• Women of childbearing potential with a male partner who could father a child must use a highly effective form of contraception from screening until 18 weeks after the last dose of the investigational treatment
• Sexually active men whose partners could become pregnant must agree to use barrier contraception (such as condoms) or abstain from sexual intercourse throughout the study and for at least 7 days after the last dose of the investigational treatment
• People who are able to follow all aspects of the study requirements
• Male patients meeting the study's participation requirements

Who may not be able to join:

• Women who are breastfeeding or who have a positive pregnancy test at the start of the study
• People who plan to make significant changes to their diet or lifestyle during the study period
• People who have concerning symptoms at the start of the study, such as difficulty or pain when swallowing, unintentional weight loss of more than 5% of body weight, signs of bleeding in the digestive tract, anaemia, a lump in the upper abdomen, or persistent vomiting lasting 7–10 days
• People who plan to use certain medications during the study, including antibiotics, probiotics, acid-reducing medicines, certain gut motility medicines, certain antidepressants, or stomach-coating medicines (confirm with trial site for the full list and exact timeframes)
• People who have been diagnosed with a serious illness such as cancer
• People who have a planned hospital stay during the study, or who have a serious health condition that the investigator considers a reason not to participate or that could affect their safety
• People with a current or recent history (within the past year) of alcohol dependence or substance abuse
• People with active psychiatric conditions that the investigator believes could affect their ability to follow study procedures
• People with unstable or uncontrolled heart conditions, moderate or severe heart failure, or significant lung, liver, kidney, digestive, blood, immune, hormonal, or other medical conditions that the investigator believes could affect study results or patient safety
• People who are employees of the study site, the investigator's team, the contract research organisation, or the study sponsor
• Close family members (first-degree relatives) of employees of the study site, investigator's team, contract research organisation, or sponsor
• People who are unable to attend all study visits or follow study procedures

Important: Always verify eligibility with the trial site directly before applying.