Gastro-oesophageal Reflux Disease Trial, Recruiting

Written by an AI model from 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 trial doctor.
• People who have had a stomach camera test (gastroscopy) within the last 6 months showing signs of damage to the oesophagus, such as erosive reflux disease or Barrett's oesophagus, as confirmed by the trial doctor.
• People who have been taking a proton pump inhibitor (a common acid reflux tablet) once each morning for at least two months, but who still experience reflux symptoms at night and have moderate sleep disturbances, as measured by a specific sleep quality questionnaire (PSQI score of 5–10).
• People who have not used certain medications — including H2 blockers, prokinetics, certain antidepressants, antibiotics, GLP1/GIP analogues, or baclofen — in the month before screening, and have not used antacids, sucralfate, or oesophageal protective agents in the week before screening.
• People whose reflux symptoms are severe enough to affect their quality of life, as reported by the person themselves.
• People aged 18 or older at the time of the screening visit.
• Women who are not pregnant (confirmed by a urine test) and not breastfeeding at the screening visit, or who are not able to become pregnant (due to surgical sterilisation, natural inability to conceive, or at least 12 consecutive months without a menstrual period).
• Women of childbearing potential with a male partner who could father a child must be willing to use a highly effective form of contraception from the screening visit until 18 weeks after the last dose of the trial medication.
• Men who have sex with women who could become pregnant must be willing to use condoms or abstain from sexual intercourse throughout the study and for at least 7 days after the last dose of the trial treatment.
• People who are able to take part in all aspects of the trial and who are able to give their voluntary informed consent.

Who may not be able to join:

• Women who are breastfeeding or who have a positive pregnancy test at the enrolment visit.
• People who make significant changes to their diet or lifestyle during the study.
• People who have warning signs at the enrolment visit, such as difficulty or pain when swallowing, unintentional weight loss of more than 5% of their body weight, signs of gastrointestinal bleeding, 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, pro-/pre-/synbiotics, proton pump inhibitors, H2 blockers, prokinetics, certain antidepressants, GLP1/GIP analogues, or baclofen, or who plan to use antacids, sucralfate, or oesophageal protective agents in the week before the study starts.
• People who have been diagnosed with a serious illness such as cancer.
• People who have planned hospitalisation, or who have a serious existing medical condition that, in the trial doctor's opinion, could affect their safety or the trial results.
• People with a current or recent history (within the past year) of alcohol dependence or misuse of substances.
• People with active psychiatric conditions that, in the trial doctor's opinion, may make it difficult to follow the study procedures.
• People with unstable or uncontrolled heart conditions, moderate or severe heart failure, or significant lung, liver, kidney, blood, immune, hormonal, or other disorders that, in the trial doctor's opinion, could affect safety or study results.
• People who are employees or close family members of employees of the trial site, research organisation, or the company sponsoring the trial.
• People who are unable to attend all study visits or follow the study procedures.

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