Trial of Alginates in Throat Symptoms

• Research type

  Research Study

• Full title

  A pragmatic, multicentre, placebo controlled, double blind, parallel, randomised controlled trial of liquid alginate (Gaviscon Advance) for the treatment of persistent throat symptoms

• IRAS ID

  1006014

• Contact name

  James O'Hara

• Contact email

  james.o'hara@newcastle.ac.uk

• Sponsor organisation

  The Newcastle upon Tyne Hospitals NHS Foundation Trust

• Eudract number

  2022-001449-19

• ISRCTN Number

  ISRCTN13949559

• Research summary

  Persistent throat symptoms (PTS), including hoarse voice, sore throat, feeling of a lump in the throat, throat clearing, mucus going from the nose into the throat and/or catarrh [a build up of mucus]) are very common. At least 60,000 new patients are referred to NHS Ear Nose and Throat (ENT) and/or Speech and Language Therapy (SaLT) departments with PTS each year in the UK.

  Specialists think that PTS can be linked to gastroesophageal reflux disease (GORD). GORD happens when the stomach contents (including stomach acid) frequently flows into the oesophagus (the food pipe) which connects the mouth to the stomach. This results in the lining of the oesophagus becoming irritated causing symptoms. The two main treatments for GORD are proton pump inhibitors (PPIs) (which reduce the amount of stomach acid) and liquid alginates (which forms a barrier on top of stomach contents to prevent them leaving the stomach and also act to make the stomach contents less harmful).

  A previous trial (TOPPITS) looked at treating PTS with PPIs. This trial found that PPIs are not an effective treatment for PTS as they were only as good as a placebo (a dummy medicine) in treating PTS symptoms. In the TALGiTS trial are looking whether liquid alginates are effective in the treatment of PTS. The liquid alginate used is Gaviscon Advance.

  ENT and SaLT department referral letters for patients presenting with PTS will be reviewed and potentially eligible patients approached for the trial. Participants will take part in the trial for 8 weeks while they are awaiting their routine appointment for their PTS. Participants
  will be randomised by computer to receive either Gaviscon Advance or a placebo medication (dummy drug), participants and local hospital staff will not know which treatment is allocated. There will be 5 contacts through the trial; one telephone consultation with a member of the trial team, three online questionnaires and one face to face clinic appointment.

• REC name

  East Midlands - Leicester South Research Ethics Committee

• REC reference

  22/EM/0205

• Date of REC Opinion

  3 Nov 2022

• REC opinion

  Further Information Favourable Opinion