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Not a traditional drug phase: Two-stage nutritional therapy concept for Crohn's Disease

The goal of this prospective treatment study is to evaluate whether the targeted avoidance of a particular food that was diagnosed to be disruptive for the intestinal barrier during confocal laser endomicroscopy (CLE) contributes significantly to stabilizing the intestinal barrier and improving abdominal symptoms, quality of life and disease activity in Crohn's Disease patients with food-related symptoms. The main questions the study aims to answer are: * whether a food-induced intestinal barrier disorder in Crohn's disease patients can be detected by endoscopy using confocal laser endomicroscopy (CLE) and a causal relationship with certain foods can be established.

Official registry: https://clinicaltrials.gov/study/NCT06719778 · Universität Duisburg-Essen · enrollment listed as 30

What this phase means

This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Two-stage nutritional therapy concept. The registry lists allocation as na. The goal of this prospective treatment study is to evaluate whether the targeted avoidance of a particular food that was diagnosed to be disruptive for the intestinal barrier during confocal laser endomicroscopy (CLE) contributes significantly to stabilizing the intestinal barrier and improving abdominal symptoms, quality of life and disease activity in Crohn's Disease patients with food-related symptoms.

They plan to enroll about 30 people at Bamberg. Taking part typically means study visits and measurements plus check-ins.

Official title (unrewritten)

Prospective Interventional Study to Evaluate the Impact of Diet and Lifestyle Modification on the Intestinal Barrier Integrity in Crohn's Disease

Interventions: Two-stage nutritional therapy concept

Primary outcome (registry wording): Improvement of the integrity of the duodenal intestinal barrier analyzed by confocal laser endomicroscopy (CLE)

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • age more than 18 years
  • Crohn's Disease for at least 6 months (date of initial diagnosis)
  • with suspected food-induced symptoms or irritable bowel syndrome-like symptoms (fulfils IBS-Rom-IV criteria) for at least 3 months with moderate to severe symptom severity
  • stable IBD-specific medication dosage for at least 3 months \[such as 5-aminosalicylates (5-ASA), thiopurines or biologicals (therapeutic antibodies such as infliximab, adalimumab, vedolizumab, etc.)\]
  • inpatient admission to the clinic for internal and integrative medicine in Bamberg for regular treatment
  • clinical indication and performance of an initial esophagogastroduodenoscopy with confocal laser endomicroscopy with detection of a food-induced intestinal barrier disorder

Public study contact (from the registry)

Angelika Schmalzl, Dr. rer. nat.

0049 951 503 11650

FIGN@sozialstiftung-bamberg.de

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

Related recruiting trials in this snapshot

FAQ about this NCT record

Is NCT06719778 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06719778?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06719778?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

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