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

NCT06953791 | Recruiting Phase 2

• 1 other identifier: CONSISTENT
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nutrition Assessment; Crohn Disease; Diet Therapy

Keywords

Nutrition; crohn disease; diet therapy; consistent

Outcome Measures

Primary Outcomes (1)

• Improvement of Quality of Life

  Measuring Quality of Life (QoL) using the IBD-Q-32-questionnaire (Inflammatory Bowel Disease Questionnaire with 32 items) * measuring the relative improvement compared to baseline * Minimum score: 32 points = bad QoL * Maximum score: 224 points = excellent QoL

  12 weeks

Secondary Outcomes (10)

• Remission (defined as CDAI≤150)

  weeks 6, 12 and 24

• Reduced fecal calprotectin

  week 12 and 24

• Patients' adherence to the diet assessed by cessation of therapy because of patients' refusal to continue and by a questionnaire

  12 weeks

• Improvement of markers of malnutrition compared between the treatment arms

  12 weeks

• Alterations in the microbiome in responders vs non-responders

  12 weeks

Study Arms (2)

Standard of care

ACTIVE COMPARATOR

Prednisolone

Drug: Prednisolone

Interventional arm

EXPERIMENTAL

Adapted Crohn's disease Exclusion Diet (aCDED)

Dietary Supplement: aCDED + Modulen

Interventions

aCDED + Modulen DIETARY_SUPPLEMENT

Unique diet + partial enteral nutrition (PEN): This group will receive as follows: * Weeks 1-6: 50% of dietary needs from PEN (Modulen, ModuLife phase I) and 50% from a limited whole food diet * Weeks 7-12: 25% of dietary needs from PEN (Modulen, ModuLife phase II) and 75% from a limited whole food diet * Weeks 12-48: liberal diet and Modulen as needed

Interventional arm

Prednisolone DRUG

1 mg/kg, tapering scheme

Standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be ≥ 18 years at the time of signing the informed consent.
• Macroscopic small bowel involvement, or isolated large bowel disease confined to the right or transverse colon confirmed by endoscopy
• Patients with a Crohn's disease activity index (CDAI) of ≥ 150
• Patients will not be excluded if they have received 5ASA or an immunomodulator for \> 8 weeks and the dose is stable, or if they start a thiopurine concurrently, as thiopurines are not considered sufficient to induce remission in active disease before 8 weeks as an isolated therapy
• Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures
• Able to adhere to the study visit schedule and other protocol requirements
• All subjects must agree to refrain from donating blood while on study drugs
• All subjects must agree not to share medication.
• Subject (male or female) is willing to use highly effective contraceptive methods during treatment and for 28 days (male or female) after the end of treatment

You may not qualify if:

• Patients with with minimal disease activity (CDAI \<150) or severe disease (CDAI \>450)
• Patients who have received corticosteroids of any kind in the previous 4 weeks
• Patients who have started an immunomodulator in the previous 8 weeks
• Any current biological or small molecule treatment
• Isolated large bowel disease iinvolving the recto-sigmoid or descending colon
• Patients with penetrating disease (abscess or fistula)
• Active perianal disease
• Fixed stricture or small bowel obstruction
• Normal fecal calprotectin
• Active extraintestinal disease (e.g. joint disease)
• Patients who have undergone an intestinal resection
• Sclerosing cholangitis
• History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product.
• Women during pregnancy and lactation Participation in other clinical trials or observation period of competing trials.

Sponsors & Collaborators

• University Hospital Tuebingen: lead
• Société des Produits Nestlé (SPN): collaborator

Study Sites (1)

Universitätsklinik Tübingen

Tübingen, 72076, Germany

RECRUITING

MeSH Terms

Conditions

Crohn Disease

Interventions

Prednisolone

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Karsten Büringer, MD

  Head of Department of Inflammatory Bowel Disease/Endoscopy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa Sinnigen, MD

CONTACT

+4970712961989; consistent@med.uni-tuebingen.de

Ronald Keller, MD

CONTACT

+491717014764; consistent@med.uni-tuebingen.de

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: May 1, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: February 5, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)