Efficacy of Fucoidan for eosinophilic oesophagitis: a phase 2 pilot study

Phase 2

Recruiting

• Conditions: Eosinophilic Oesophagitis; Inflammatory and Immune System - Allergies; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12621001406897
• Lead Sponsor: Griffith University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-19
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in EOE disease activity based on oesophageal eopsinophil count<br><br>[ 13 weeks post treatment initiation.];Change in EoE disease activity based on change in Dysphagia Symptom Questionnaire score of >30%[ 13 weeks post treatment initiation]

Secondary Outcome Measures

Name	Time	Method
Oesophageal microbiome: diversity score (count of identified operational taxonomic units).<br>[ 13 weeks post treatment initiation ];Oesophageal biopsy immune gene expression profiling: the ratio of Th /Th2 inflammatory pathways and cells[ 13 weeks post treatment initiation ];Faecal microbiome: diversity score (count of identified operational taxonomic units)<br>[ 13 weeks post treatment initiation];Oesophageal microbiome: Microbial composition[ 13 weeks post treatment initiation];Faecal microbiome: Microbial composition[ 13 weeks post intervention initiation ]