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

Comparison of Quality of Life During a Flare of Crohn's Disease Treated With Standard of Care or an Adapted Crohn's Disease Exclusion Diet With Partial Enteral Nutrition in Adult Patients

Comparison of Quality of Life During a Flare of Crohn's Disease Treated With Prednisolone or aCDED With PEN in Adult Patients (NCT06953791) is a Phase 2 interventional studying Crohn Disease and Nutrition Assessment, sponsored by University Hospital Tuebingen. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Crohn Disease and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 52 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Crohn Disease subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - Must be ≥ 18 years at the time of signing the willing to sign a consent form. - 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 willing to sign a consent form 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 Who Should NOT Join This Trial: - 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * 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 Exclusion Criteria: * 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.

Treatments Being Tested

DIETARY_SUPPLEMENT

aCDED + Modulen

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

DRUG

Prednisolone

1 mg/kg, tapering scheme

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Universitätsklinik Tübingen

Tübingen, Germany

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06953791), the sponsor (University Hospital Tuebingen), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06953791 clinical trial studying?

Who can participate in NCT06953791?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06953791?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06953791. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06953791. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.