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NCT06362863

Evaluation of Enteral Nutrition Biscuits for Inducing Remission in Moderate-to-severe Crohn's Disease

Sponsor: Ping An

View on ClinicalTrials.gov

Summary

By conducting a randomized controlled study of the role of enteral nutrition biscuits in the induction of remission in moderate-to-severe Crohn's disease, we will evaluate to investigate the role of enteral nutrition biscuits in the induction and remission phases of moderate-to-severe Crohn's disease; to assess patient adherence to enteral nutrition biscuits and the timing of their application; to assess the role of enteral nutrition biscuits in biologically refractory patients; and to assess the role of enteral nutrition biscuits in the remission of perianal, small bowel, and colonic lesions.

Official title: A Randomized Controlled Study to Evaluate the Efficacy of Enteral Nutrition Biscuits in Inducing Remission in Moderate to Severe Crohn's Disease

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-06

Completion Date

2025-12

Last Updated

2024-04-12

Healthy Volunteers

Conditions

Crohn's Disease

Interventions

DIETARY_SUPPLEMENT

enteral nutrition biscuits

Addition of enteral nutritional biscuits to existing pharmacological treatment.

Inclusion Criteria: * Age≥ 18 years old, gender is not limited * Patients with a combination of clinical manifestations, laboratory examinations, endoscopy, imaging examinations and histopathological examinations to diagnose Crohn's disease for at least 6 months * Patients with Crohn's disease with a CDAI score of \> 220 and an HBI of ≥5 * Voluntarily signed written informed consent Exclusion Criteria: * Patients with newly diagnosed Crohn's disease, no history of treatment with 5-aminosalicylic acid, biological or immunological agents * Current presence of an abscess or suspected abscess * Positive results of stool culture or other intestinal pathogens * Use of any antibiotics, prebiotics, probiotics, nutrition bars and enteral nutrition in the past 4 weeks * Known hypersensitivity to any of the components administered in this study * Severe infection (CTC AE\> grade 2) within 4 weeks prior to the start of the study * Patients who have recently undergone digestive surgery (\< 1 month) or have not been completely cured * Patients with severe gastrointestinal problems (such as life-threatening intestinal obstruction, perforation, and bleeding) requiring immediate treatment * Have an underlying medical condition that affects treatment * Pregnant or lactating women * Positive for human immunodeficiency virus * Known history of active pulmonary tuberculosis. Subjects with suspected active tuberculosis should be examined for chest x-ray, sputum, and exclusion by clinical signs and symptoms * Patients with untreated chronic hepatitis B or hepatitis B virus carriers with chronic hepatitis B virus DNA exceeding 500 IU/mL, or patients with active hepatitis C should be excluded. Patients with inactive HBsAg, treated and stable hepatitis B patients (HBV DNA \<500 IU/mL), and cured hepatitis C patients may be enrolled. Subjects with positive hepatitis C virus antibodies are eligible to participate in the study only if they have a negative HCV RNA test result * Known history of psychotropic substance abuse, alcoholism, and drug abuse * Any condition that, in the opinion of the investigator, the participant should be excluded from the study