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

NCT ID: NCT06362863

Last Updated: 2024-04-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-30
• Study Completion Date: 2025-12-31

Brief 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.

Detailed Description

This project is a randomized controlled study evaluating the effects of enteral nutrition biscuits during the induction and remission phases of moderate to severe Crohn's disease. The study subjects were patients with moderate to severe Crohn's disease, and the control group received conventional treatment with existing drugs; The experimental group added oral enteral nutrition biscuits to intervene on the basis of existing drugs. Evaluate the clinical response rates of patients at 2, 4, 8, 12, and 24 weeks after intervention; Nutritional status before and after intervention, incidence and severity of perianal lesions, and remission rate of small intestine and colon lesions.

Conditions

Crohn's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Enteral nutrition biscuits

Addition of enteral nutritional biscuits to existing pharmacological treatment.

Group Type: EXPERIMENTAL

enteral nutrition biscuits

Intervention Type: DIETARY_SUPPLEMENT

Addition of enteral nutritional biscuits to existing pharmacological treatment.

Conventional drug therapy

No nutritional intervention, use of existing medication.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

enteral nutrition biscuits

Addition of enteral nutritional biscuits to existing pharmacological treatment.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ping An

OTHER

Sponsor Role: lead

Responsible Party

Ping An

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ping An

Role: PRINCIPAL_INVESTIGATOR

Renmin Hospital of Wuhan University

Central Contacts

Ping An

Role: CONTACT

anping_05@163.com

+8618627068700

Other Identifiers

WDRY2024-K027

Identifier Type: -

Identifier Source: org_study_id