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The contribution of the intestinal permeability in the systemic inflammation in patients with COPD during acute exercise

The contribution of the intestinal permeability in the systemic inflammation in patients with COPD during acute exercise - Intestinal permeability during exercise (IPEX)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON33923
Enrollment
105
Registered
2010-01-27
Start date
2010-06-15
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD

Interventions

None listed

Sponsors

Universiteit Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Diagnosis of COPD, both male and female, age-range from 50 to 70 years, no respiratory tract infection or exacerbation of the disease for at least 4 weeks before the study, capable to provide informed consent, presence of other non-gastro-intestinal related, non-cardiovascular and non-renal chronic diseases are allowed in case the clinical status is stable for at least 4 weeks before the study;

Exclusion criteria

Exclusion criteria: External oxygen supplementation at rest; investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements; participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study; any kind of gastro-intestinal complains or gastrointestinal disease; use of NSAID (ibuprofen, acetylsalicic acid, naproxen, meloxicam, diclofenac); subjects who are still smoking as smoking is known to increase the intestinal permeability.

Design outcomes

Primary

MeasureTime frame
Biochemical parameters: markers of intestinal permeability in plasma (intestinal fatty acid binding protein (IFABP), ileal lipid-binding protein (ILBP), claudine) and urine (sugars)

Secondary

MeasureTime frame
Plasma markers of systemic inflammation interleukine 6 (IL-6), tumor necrosis factor-a (TNF-a), TNF soluble receptors 55 en 75, C-reactive protein (CRP), lipoprotein binding protein (LBP) and chemotactic cytokine ligand 18 (CCL-18).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)