크론병 수술 후 경구 EXL01의 재발 예방 효과를 위약과 비교하는 24주 임상시험입니다.

EXL01 administered with or without SoC treatment orally, once a day during 24 weeks

Randomisation will be stratified on post-surgical treatment (none vs anti-TNF), and on smoking status (non-smoker vs smoker).

After surgery for Crohn's disease, eligible patients will be randomized 1:1 to receive oral EXL01 or placebo with or without SoC treatment (based on investigator decision) for up to 24 weeks

Placebo administered with or without SoC treatment orally, once a day during 24 weeks

EXL01은 표준 치료(SoC)와 병행하거나 병행하지 않고 24주 동안 하루에 한 번 경구 투여합니다.

크론병 수술 후, 적격 환자는 최대 24주 동안 표준 치료(SoC) 병행 여부와 관계없이 경구용 EXL01 또는 위약을 투여받도록 1:1 비율로 무작위 배정됩니다(연구자 판단에 따름).

24주 동안 매일 1회, 표준 치료(SoC) 병행 여부와 관계없이 위약을 경구 투여

Anthony Buisson

Mathieu Uzzan

Franck Carbonnel

Pauline Wils

Stéphane Nancey

Mélanie Serrero

Pierre Blanc

Bénédicte Caron

Arnaud Boureille

Xavier Hebuterne

Matthieu Allez

Philippe Seksik

크론병 수술 후 재발 방지에 있어 EXL01의 표적 결합

크론병 환자의 가족을 대상으로 웹 기반 위험 추정 도구를 사용해 생활 습관 변화를 유도하는 연구입니다.

Personalized Risk Estimation for Crohn's Disease (PRE-Crohn's) tool

We will develop a web-based, personalized risk estimation for CD (PRE-Crohn's) tool to quantitate participants' relative risk (RR) and lifetime risk of CD based on known risk factors for disease. We will consider the following risk factors for Crohn's disease: body mass index (BMI); smoking history; NSAID use; intake of fruit, fiber, and added sugar; oral contraceptive use (females); antibiotic use; breast-feeding; pets in home; and anti-microbial biomarker positivity. This tool will also display a participants' personalized summary of their risk factors for CD as well as educational tools for modifying these factors. Construction of this tool is based on the Your Disease Risk tool developed by the Siteman Cancer Center at Washington University in St. Louis School of Medicine. The interventional group will also receive standard education about Crohn's disease (comparison group intervention) via the web-based tool.

The comparison group will receive standard education about Crohn's disease, which will include information regarding the prevalence of disease, clinical presentation including signs and symptoms of disease, and treatment options including available medications. Upon completion of the study, the comparator arm will be given the option of receiving their personalized risk of Crohn's disease with the PRE-Crohn's tool as well.

Standard Crohn's Disease Education

Emily W. Lopes, MD

Patients who accept participation and are randomized to receive dietary advice on the CDED diet will be included in the intervention group.

Patients in the experimental group will receive professional dietary advice on how to adhere to CDED for 12 weeks, in addition to anti-TNF therapy while patients in the control group will receive only anti-TNF therapy for the entire duration of the study.

Diet adherence is completely voluntary and is not enforced in any way. CDED is divided into 3 phases, the first two, grouped as the induction phase, with 6 weeks of strict diet and 6 weeks to gradual food reintroduction, followed by 12 weeks of patients follow-up.

Five foods (chicken, eggs, potatoes, apple and bananas) are permitted at the start of the diet; the patient can then choose to consume a range of permitted foods at will, the variability of which increases after the first six weeks

CDED (Crohn's Disease Exclusion Diet) in addition to anti-TNF therapy

The control group will receive only anti-TNF therapy as per the standard of care and guidelines recommendation

The control group will receive only anti-TNF therapy as per standard of care. This therapy is recommended by guidelines and is the cornerstone of treatment of Crohn's disease and ulcerative colitis.

Anti-TNF Therapy

Tommaso Lorenzo Parigi, MD

Annunziata Bruno, MS

Mariangela Allocca, MD

Participants in this group will receive anti-TNF-α biologics (infliximab 5mg/kg IV at weeks 0, 2, 6, and 14, or adalimumab subcutaneous injection at standard doses) combined with the Crohn's Disease Exclusion Diet (CDED). The CDED protocol includes detailed dietary guidance specifying allowed foods (rice, certain vegetables and fruits, fish, poultry, olive oil) and prohibited items (ultra-processed foods, nuts, legumes, butter). Patients will maintain daily food diaries and receive frequent supervision and guidance from researchers to ensure dietary compliance.

Participants will receive anti-TNF-α biologics (infliximab 5mg/kg IV at weeks 0, 2, 6, and 14, or adalimumab subcutaneous injection at standard doses) combined with the Crohn's Disease Exclusion Diet (CDED). The CDED protocol includes detailed dietary guidance specifying allowed foods (rice, certain vegetables and fruits, fish, poultry, olive oil) and prohibited items (ultra-processed foods, nuts, legumes, butter). Patients will maintain daily food diaries and receive frequent supervision and guidance from researchers to ensure dietary compliance throughout the 14-week study period. This combined intervention aims to evaluate whether CDED can synergistically enhance the efficacy of standard biologic therapy in achieving mucosal healing in Crohn's disease patients.

Crohn's Disease Exclusion Diet

Participants in this group will receive anti-TNF-α biologics alone (infliximab 5mg/kg IV at weeks 0, 2, 6, and 14, or adalimumab subcutaneous injection at standard doses) without any dietary intervention. This group serves as the control to evaluate the additional benefit of CDED when combined with standard biologic therapy. No specific dietary restrictions or guidance will be provided to this group.

Sixth Affiliated Hospital, Sun Yat-sen University

크론병 수술 후 재발 방지에 있어 EXL01의 표적 결합

크론병개인별 위험 예측 도구(PRE-Crohn's), 표준 크론병 교육

항TNF 치료와 더불어 CDED(크론병 배제 식이요법), 항TNF 치료

크론병 배제 식단