A study investigating dietary fiber supplementation as an effective therapy to reduce inflammation in chronic obstructive pulmonary disease.

Not Applicable

Recruiting

• Conditions: Chronic obstructive pulmonary disease; Respiratory - Chronic obstructive pulmonary disease

• Registration Number: ACTRN12618001044213
• Lead Sponsor: Annalicia Vaughan

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-06-22
• Last Update Posted: 19 October 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Patients will have COPD as defined by the GOLD guidelines (chronic airflow limitation that is not fully reversible, with post-bronchodilator FEV1/FVC <70% and FEV1 <80% predicted). COPD patients will be former smokers of >10 pack-years, who are recruited during stability (>6 weeks since an exacerbation). Healthy participants will have self-reported good health, be free of any major medical conditions, and will be never smokers.

Exclusion Criteria

Exclusion criteria will be use of any continuous prophylactic antibiotics or oral steroids in the past 3 months; current smoking; comorbid lung diseases (asthma, lung cancer, interstitial lung disease, bronchiectasis) that interfere with study outcomes; other comorbidities with established altered microbiome (including IBD, irritable bowel syndrome), and extreme dietary habits significantly impact on gut microbiome composition.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in airway inflammation - measuring proinflammatory cytokine levels in sputum samples before and after the 28 day intervention (Interleukin-8, tumor necrosis factor-aloha and myeloperoxidase).[After 28 day supplementation with dietary fiber or placebo]

Secondary Outcome Measures

Name	Time	Method
Altered microbiome - whole genome sequencing of extracted DNA from stool and sputum samples before and after the 28 day intervention [After 28 day supplementation with dietary fiber or placebo];Change in systemic inflammation - measuring full blood cell count, fibrinogen level. C-reactive protein levels, and inflammatory cytokine levels (tumor necrosis factor-alpha) in blood samples before and after the 28 day intervention[After 28 day supplementation with dietary fiber or placebo]