Crohn'sRecruiting
Comparison of Quality of Life During a Flare of Crohn's Disease Treated With Prednisolone or aCDED With PEN in Adult Patients
Phase 2 · Testing aCDED + Modulen and Prednisolone · 1 site · University Hospital Tuebingen
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing aCDED + Modulen (a dietary supplement) and Prednisolone (a drug) as a possible treatment. Condition(s) listed: Crohn Disease, Nutrition Assessment and Diet Therapy.
Participants are assigned to groups by chance (randomized).
It is single-blind: participants do not know which group they are in.
Phase 2 studies test whether a treatment shows signs of working, and keep checking safety, in a larger group of people with the condition.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 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
Plus 6 more requirement(s). There are also 14 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 52 participants are expected to take part.
- Start date: 2026-02-01.
- Main results expected around 2028-02-01 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Germany.
Main thing being measured
- Improvement of Quality of Life (12 weeks)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Phase 2 |
| Study type | Interventional |
| Conditions | Crohn Disease; Nutrition Assessment; Diet Therapy |
| Lead sponsor | University Hospital Tuebingen |
| Collaborators | Société des Produits Nestlé (SPN) |
| Enrollment | 52 (estimated) |
| Start date | 2026-02-01 |
| Primary completion (est.) | 2028-02-01 |
| First posted | 2025-05-01 |
| Last updated | 2026-02-05 |
| Official title | 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 |
| ClinicalTrials.gov ID | NCT06953791 |
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 - Prednisolone (Drug)
1 mg/kg, tapering scheme
Full eligibility criteria (from the record)
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.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Universitätsklinik Tübingen | Tübingen | Germany | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.