None listed
Conditions
Brief summary
Seaweeds comprise a diverse range of marine organisms containing biologically active metabolites that are being explored for their therapeutic effect(s) on a range of health conditions. This project provides a novel opportunity to assess the role of inflammatory processes and the microbiome in the oesophagus in Eosinophilic oesophagitis (EoE). The aim of this study is to examine the clinical effectiveness of fucoidan supplementation in alleviating symptoms of Eosinophilic oesophagitis(EoE). To better understand the local immune pathways and responsiveness to supplementation oesophageal biopsy samples will be used to characterise immune and inflammatory signalling and to assess microbiome composition at the mucosal oesophageal surface.
Interventions
Patients will be treated with steroids and proton pump inhibitor (PPI) therapy for a minimum of 6 weeks as part of the routine clinical management (prescribed by Gastroenterologist and/or in consultation with participants own GP). Only the study medication will be provided as part of the study. Participants will take the study medication in combination with routine clinical management for an initial period of 6 weeks, and then continue taking the study medication for a further 6 weeks (Total fuc
Patients will be treated with steroids and proton pump inhibitor (PPI) therapy for a minimum of 6 weeks as part of the routine clinical management (prescribed by Gastroenterologist and/or in consultation with participants own GP). Only the study medication will be provided as part of the study. Participants will take the study medication in combination with routine clinical management for an initial period of 6 weeks, and then continue taking the study medication for a further 6 weeks (Total fucoidan/placebo supplementation will be 12 weeks). Participants will be randomised to one of two treatment groups. (i) A formulation containing 100mg daily of 85% Maritech® (Marinova, Tasmania, Australia). (ii) Placebo: same formulation as the fucoidan supplement but without the active ingredient The active treatment will be administered via an oral gel, once per day. Participants will be asked to drink the gel slowly, allowing it to coat the oesophagus thoroughly, and asked to refrain from eating for 30 minutes afterwards. To monitor compliance, participants will be asked to complete a daily symptom and medication diary, as well as take part in a follow up phone call at the half way point of the study (6 weeks). A text message/email reminder will be sent out twice per week. Participants will also be asked to return the bottle of supplement at the completion of the study for the research team to measure overall compliance.
Sponsors
Griffith University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
- Be aged 18-60 years; - Have EoE diagnosed from oesophageal biopsy, based on eosinophil count greater than15 cells per high powered field; - Be prescribed treatment with steroids and proton pump inhibitor (PPI) therapy for a minimum of 6 weeks as part of the routine clinical management and continue taking the study medication for a further 6 weeks.
Exclusion criteria
- Report antibiotic, probiotic or symbiotic use in the previous 14 days; - Report gastrointestinal or respiratory disease, autoimmune disease or other diseases, in particular Crohn’s Disease or Ulcerative Colitis; - Return a finding of malignancy on biopsy results post gastroscopy procedure. - Allergic, sensitive or intolerant to (one of) the ingredients of the study product
Outcome results
None listed