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Jejunum ex vivo

Jejunum ex vivo - JEJUNEX

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON56681
Enrollment
24
Registered
2024-04-09
Start date
2025-03-06
Completion date
Unknown
Last updated
2025-09-01

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

Conditions

Onderzoek naar de functionaliteit en gezondheid van de dunne darm in mensen met obesitas. Intestinal functionality and health intestinal health

Interventions

None listed

Sponsors

Rijnstate Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Patients with the age of 18 or older - BMI > 40 kg/m2 - BMI > 35 en < 40, with a obesity related comorbidity of which is suspected  that it improves after surgery induced weight loss.

Exclusion criteria

Exclusion criteria: no exlcusion criteria

Design outcomes

Primary

MeasureTime frame
The primary endpoint of this study is to determine transport functionality, integrity, and viability in each intestinal biopsy. The transport functionality is shown as the ratio of transcellular to paracellular transport, also called the Papp ratio (Papp = Apparent permeability rate). Permeability of FITC-Dextran (4000 Dalton, FD4) determines intestinal integrity, and secretion of lactate dehydrogenase (LDH) determines tissue viability.

Secondary

MeasureTime frame
In addition to these primary endpoints, processes that play an important role in intestinal and overall health will also be measured in each biopsy. This includes: 1) absorption and metabolism of foods and medicines, 2) (influencing) intestinal permeability, 3) release of satiety hormones, 4) local immunological reactions, and 5) interaction with the intestinal microbiome.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)