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Comparison of Quality of Life During a Flare of Crohn's Disease Treated With Prednisolone or aCDED With PEN in Adult Patients
Bu çalışma, Crohn hastalığının (Crohn's disease) alevlenme döneminde Prednisolone tedavisi ile kısmi enteral beslenmeli özel bir diyet (aCDED) yaklaşımının yaşam kalitesi üzerindeki etkilerini karşılaştırmaktadır. Çalışmaya, 18 yaş ve üzeri, Crohn hastalığı aktivite indeksi 150 ve üzeri olan yetişkin hastalar alınmaktadır. Faz 2 aşamasında yürütülmekte ve halen katılımcı almaktadır.
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
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.