Decoding the Clinical Impact of Host and Microbial Intestinal Proteomic Landscape in Crohn's Disease

ConditionCrohn Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorWeizmann Institute of Science

About this trial

In this study, the investigators will explore our protein-based platform assessing commensals potentially contributing to features of CD, while assessing the global composition and abundance of AMPs expressed in the GI tract under specific CD-relevant clinical contexts. This would enable us to (a) identify new commensals contributing to features of CD spectrum and various sub-types; (b) uncover the mechanistic basis of dysbiosis in CD (c) utilize the pipeline to develop new theranostic for disease exacerbation, complication and treatment responses; and (d) potentially enable future exploitation of novel AMP combinations, and their respective antimicrobial capacity to counteract dysbiosis in CD.

Uncovering the proteomic manifestations of perturbed host-microbiome communications in CD will eventually enable the development and validation of clinical non-invasive surrogate markers, mechanistically determine causative drivers of CD, and potentially facilitate the development of novel therapeutic interventions.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age ≥ 18

Candidates for a medically-indicated, diagnostic colonoscopy due to suspected new-onset CD.

Naïve to any medical or nutritional intervention.

Disqualifiers

Established diagnosis of inflammatory bowel disease (IBD) with prior treatment.

Chronic gastro-intestinal disorder (e.g. celiac disease, eosinophilic esophagitis, collagenous gastritis, autoimmune gastritis, etc.).

Type 1 or type 2 diabetes mellitus.

Past or present history of malignancy.

Trial population

CD study group will consist of candidates for a medically-indicated, diagnostic colonoscopy due to suspected new-onset CD. Naïve to any medical or nutritional intervention. for healthy controls: Age- and gender-matched patients to the CD group, admitted for non-specific GI complaints (such as changes in bowel movements, bloating, abdominal pain) or routine screening for colorectal cancer as part of primary prevention per clinical guidelines.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • colonoscopy procedure

    Other intervention

    Candidates for a medically-indicated colonoscopy due to suspected new-onset CD or non-specific GI complaints or routine screening for colorectal cancer as part of primary prevention. colonoscopy will not be done for research purposes only .

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: crohn disease patients1 intervention
Group B: healthy controls1 intervention

Trial outcomes

Primary outcomes

1

Characterization of gut microbiota and associated molecules in Crohn's disease and healthy human gastrointestinal tract

Identification of changes in fecal microbiota and associated molecules using multi-dimensional analysis of fecal samples, biopsies and brushes collected during endoscopy

Time frame
1 week

Secondary outcomes

Other outcomes

Sponsors and contacts

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Weizmann Institute of Science

Lead sponsor

HaEmek Medical Center, Israel

Collaborator

University of Hamburg-Eppendorf

Collaborator