An unblinded, randomised, interventional cohort two-arm trial of alginate with lifestyle interventions versus PPI in the management of mild to moderate gastro-oesophageal reflux
Gastro-oesophageal reflux disease (GORD)
Participants will be randomised into two trial arms: 1. Alginate + lifestyle consultation 2. Omeprazole A randomisation schedule generated in SAS version 9.4 will be used to randomise subjects. Trial arm 1: Alginate + lifestyle consultation: Participants will be given an alginate dose of 20 ml (10 ml of alginate contains sodium alginate 500 mg, sodium bicarbonate 213 mg and calcium carbonate 325 mg per 10 ml) to be taken orally four times a day over the first treatment period (4 weeks), to initiate symptom control. Participants will also be given a GORD lifestyle leaflet at the start of phase 1. The content included in the leaflet is in line with the normal information given to patients as per standard of care in the United Kingdom. Participants will then switch to 10–20 ml to be taken when required up to four times a day for the second treatment period (20 weeks). The purpose of subsequent PRN treatment is to manage symptoms adequately during the structured lifestyle alteration phase. The lifestyle intervention will consist of two 45-minute diet and lifestyle consultations with a registered dietician. This will consist of motivational interviewing to help enforce the written information provided in the GORD leaflet. The consultation will be a personalised approach to help direct participants where necessary. For some individuals this may include promoting a healthy BMI, advice around alcohol consumption, smoking, portion sizes, carbonated drinks etc. The diet and lifestyle advice will be personalised to the individual and act as a two-way discussion and explore changes to lifestyle and diet and help implement recommendations. Trial arm 2: Participants will be given omeprazole 20 mg gastro-resistant capsules to be taken once in the morning, 20 to 30 minutes before food over the first treatment period (4 weeks). Participants will also be given a GORD lifestyle leaflet at the start of phase 1. The content included in the leaflet is in line with the normal informa
Current key inclusion criteria as of 13/04/2026: 1. Participant has provided written informed consent and is able to comply with all study restrictions 2. Participant is male or female and aged 18 to 70 years old 3. A 1-week screening window in which: the daily HRDQ score is >0.7 on ≥3 days; no more than 2 days total with a severe score reported in either heartburn or regurgitation symptoms*; and no more than a mild score reported in dyspepsia symptoms at any point during the screening window. This will be assessed with a 7-day collection of HRDQ where participants must complete a minimum of 6 days of data collection. * Severe cannot be recorded on more than 2 days for heartburn or regurgitation combined. 4. Participants of childbearing potential* must have a negative urine pregnancy test at screening and be willing to use an acceptable method of contraception throughout the study and for one menstrual cycle after last drug administration. In accordance with the Clinical Trial Facilitation Group (CTFG) recommendations, for the purpose of the study the following methods of contraception are acceptable: 4.1. Combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or implantable) 4.2. Progestogen-only oral hormonal contraception (oral, injectable, or implantable) 4.3. Male or female condom with or without spermicide 4.4. Cap, diaphragm or sponge with spermicide 4.5. Intrauterine device (IUD) 4.6. Intrauterine hormone-releasing system (IUS) 4.7. Vasectomised partner (who has received medical assessment of the surgical success) 4.8. Bilateral tubal occlusion 4.9. Sexual abstinence (defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments and must be the preferred and usual lifestyle of the participant) * For the purposes of this study, a participant is considered of childbearing potential, i.e. fertile, following menarche and unti
Current key exclusion criteria as of 13/04/2026: 1. Female participant who is pregnant as confirmed by a positive pregnancy test (urine dipstick at screening) or is lactating 2. Participant has a current and previous clinically significant medical history as deemed by the Investigator, including but not limited to cardiovascular, respiratory, gastrointestinal, neurological, metabolic and psychiatric disorders 3. Participant with known Los Angeles (LA) grade C or D oesophagitis, previously demonstrated on endoscopic investigation 4. Participant with a previous or current diagnosis of Barrett’s oesophagus 5. Participant with previous evidence of neoplasia on gastroscopy confirmed via histology 6. Participant with red flag symptoms (i.e. dysphagia, unintentional weight loss, unexplained anaemia, abdominal mass) unless satisfactorily investigated 7. Participant with renal impairment 8. Participant has previously been prescribed any PPI for more than 28 consecutive days for any indication in the last 6 months or has previously been prescribed any PPI for more than 28 consecutive days for GORD symptoms historically. 9. Participant is currently taking any GLP-1 agonist medication (e.g. semaglutide) 10. Participant has a history of drug or alcohol abuse in the 2 years prior to screening, alcohol use disorders will be screened for using the AUDIT questionnaire 11. Participant has a contraindication to using the investigational products as per the product's SmPC 12. Participant has a known history of previous allergy/sensitivity to PPIs, calcium carbonate, sodium alginate, sodium bicarbonate, substituted benzimidazoles, any of the excipients contained within the investigational medicinal products (alginate and omeprazole) or the non-investigational medicinal product (i.e. lactulose, midazolam, lidocaine, and xylocaine) 13. Participant has received an investigational product or participated in another trial involving a marketed or investigational drug in the 90 days prior to