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NCT Number: NCT06770140

Unraveling the Blood Microbiome in Postoperative Recurrence of Crohn's Disease

Crohn's disease, a chronic inflammation of the gastro-intestinal tract, is a disease with a complex pathogenetic background. Hereditary factors, environmental factors and the gut flora play a varying role in its onset, however, this role remains unclear to date. We hypothesize to detect tiny fragments of microbial DNA from the gut in the bloodstream, due to disruption in the natural defences of the gut lining. If this is true, it may hold the key to understanding why Crohn's disease recurs after surgery.

Our objective in this study is to test retrospectively, if we can detect any difference in microbial DNA from the blood of ileocolonic resection (ICR) patients that do and do not show recurrence at the time of follow-up endoscopy at 6 months.

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Key information

Conditions

Crohn's Disease (CD)

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Erasmus Medical Center

Rotterdam, South Holland, 3015 GD, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of Crohn's Disease
  • Adult ≥ 16 years
  • Undergoing an ileocolonic resection or reresection
  • Written informed consent

Exclusion criteria

  • Use of antibiotics in the past 8 weeks at the timepoints when blood is withdrawn and feces is collected.
  • Use of probiotics in the past 8 weeks at the timepoints when blood is withdrawn and feces is collected.
  • Not willing to collect extra biosamples

Treatment and study plan

Primary outcomes

  1. Differences in bloodmicrobiome between recurrence & non recurrence patients.

    Time frame: From enrollment to the postoperative endoscopy (at 6 months follow-up).

    To test retrospectively, if we can detect any difference in microbial DNA from the blood of ICR patients that do and do not show recurrence, defined as a Rutgeerts score ≥ i2b at the time of follow-up endoscopy at 6 months.

Secondary outcomes

  1. o To identify blood biomarkers predicting postoperative recurrence in Crohn's disease.

    Time frame: From enrollment to the postoperative endoscopy (at 6 months follow-up).

  2. o To identify histological parameters predicting postoperative recurrence in Crohn's disease.

    Time frame: From enrollment to the postoperative endoscopy (at 6 months follow-up).

  3. o To correlate blood biomarkers with fecal biomarkers predicting postoperative recurrence in Crohn's disease.

    Time frame: From enrollment to the postoperative endoscopy (at 6 months follow-up).

Study contacts

Contact information is provided by the study sponsor or research team.

Merel Verweij, MD

CONTACT

[email protected]

+31650033976

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Registry information

Acronym: IBDbloom

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jan 13, 2025
Registry last updated
Jan 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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