NCT06953791 (CONSISTENT) is a Phase 2 clinical trial of aCDED + Modulen in Crohn Disease, sponsored by University Hospital Tuebingen.

Who is sponsoring NCT06953791?

NCT06953791 is sponsored by University Hospital Tuebingen.

What drugs are being tested in NCT06953791?

Interventions in NCT06953791: aCDED + Modulen, Prednisolone.

What condition does NCT06953791 study?

NCT06953791 studies Crohn Disease, Nutrition Assessment, Diet Therapy.

Is NCT06953791 still recruiting?

NCT06953791 is currently recruiting now. Last updated 5 February 2026.

Last reviewed 2026-02-05 · How we verify

NCT06953791: CONSISTENT

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Comparison of Quality of Life During a Flare of Crohn's Disease Treated With Prednisolone or aCDED With PEN in Adult Patients

Recruiting now Phase 2 Last updated 5 February 2026

What this trial tests

Phase 2 trial testing aCDED + Modulen in Crohn Disease in 52 participants. Currently enrolling.

Timeline

1 February 2026

Primary endpoint
1 February 2028

1 February 2028

Quick facts

Lead sponsor	University Hospital Tuebingen
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	52
Start date	1 February 2026
Primary completion	1 February 2028
Estimated completion	1 February 2028
Sites	1 location across Germany

Drugs / interventions tested

aCDED + Modulen
Prednisolone — full drug profile →

Conditions studied

Crohn Disease — all drugs for Crohn Disease →
Nutrition Assessment — all drugs for Nutrition Assessment →
Diet Therapy — all drugs for Diet Therapy →

Sponsor

University Hospital Tuebingen

Who can join

18 and older, any sex, with Crohn Disease or Nutrition Assessment. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Crohn's disease (CD), a type of inflammatory bowel disease (IBD), is on the rise globally. Although medical treatments have advanced, CD still leads to significant health issues due to disease progression and medication side effects. Exclusive enteral nutrition (EEN) is a recommended first-line treatment for pediatric CD, proving more effective than oral corticosteroids without side effects. However, EEN demands strict adherence, making it challenging for patients, particularly adults. In 2019, Levine et al. found that a combination of a specific diet (CD exclusion diet, CDED) and partial enteral nutrition (PEN) was as effective as EEN in inducing remission in pediatric patients, with better tolerance and adherence. CDED focuses on whole foods and aims to minimize harmful dietary components affecting the gut. In clinical practice, an adapted CDED (aCDED) has been used to provide more food choices, but it lacks validation in clinical trials. An aCDED that considers regional and seasonal food variations could enhance patient adherence and align with modern dietary preferences. This study aims to compare the quality of life during a flare up of Crohn's disease treated with standard of care or an adapted Crohn's disease exclusion diet with partial enteral nutrition in adult patients.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Crohn Disease

Currently open trials in the same condition.

NCT07310095 — A Study to Evaluate the Efficacy of Guselkumab in Chinese Participants With Crohn's Disease (CD) · Phase 4 · recruiting
NCT07364734 — Epidemiological Characteristics and Efficacy Evaluation of Difficult-To-Treat Crohn's Disease · recruiting
NCT07170462 — Cranberry and Gut Health in Crohn's Disease · EARLY_PHASE1 · recruiting
NCT07196722 — A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease · Phase 2, PHASE3 · recruiting
NCT06742385 — Evaluation of a Remote Monitoring Application in the Follow-up of Patients With Active Inflammatory Bowel Diseases · NA · recruiting

Other University Hospital Tuebingen trials

Trials by the same sponsor.

NCT07378670 — DEfeating PEnile CAncer-2 · NA · recruiting
NCT07276503 — Verification of a New Predictive Delirium Score in Adults With Elective Cardiac Valve or Bypass Surgery With Perioperati · not yet recruiting
NCT07411365 — Dual-task Cognitive-motor Telerehabilitation in Persons With PD-MCI · NA · not yet recruiting
NCT07378891 — Artificial-Intelligence-based Early Detection of Diabetic Retinopathy (FUNDUS AI) · enrolling by invitation
NCT07151378 — Intestinal Levodopa + Entacapone Therapy (Lecigon®) to Counteract Dopaminergic Desensitization and Neuropsychiatric Comp · Phase 3 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06953791 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University Hospital Tuebingen
Last refreshed: 5 February 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06953791.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing