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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Crohn's Disease
• Intervention / Treatment: Dietary supplement: enteral nutrition biscuits

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.

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ping An; Phone Number: +8618627068700; Email: anping_05@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Enteral nutrition biscuits; Addition of enteral nutritional biscuits to existing pharmacological treatment.	Dietary supplement: enteral nutrition biscuits; Addition of enteral nutritional biscuits to existing pharmacological treatment.
No Intervention: Conventional drug therapy; No nutritional intervention, use of existing medication.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Crohn's disease activity index, CDAI	Assessment was performed using the Crohn's disease activity index (CDAI), with a clinical response defined as a CDAI score <150.	2、4、8、12、24 weeks after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Induced remission success rate	Probability of success of intervention in inducing CD remission.	2、4、8、12、24 weeks after intervention
Gastrointestinal Symptom Rating Scale (GSRS) score	Gastrointestinal Symptom Rating Scale (GSRS) score.	2、4、8、12、24 weeks after intervention
Gastrointestinal symptom remission	Gastrointestinal Symptom Rating Scale (GSRS) scores after 4 weeks of intervention.	4 weeks after intervention
Detection of antibody levels to the biologics used in sera from patients with secondary loss of response to the biologics	Detection of antibody levels to the biologics used in sera from patients with secondary loss of response to the biologics.	1、4、8、12、24 weeks after intervention
Incidence and severity of perianal lesions in both groups	Assess the incidence and severity of perianal lesions in both groups.	1、8、24 weeks after intervention
Rate of endoscopic remission of small bowel and colon lesions in both groups	Assess the rate of endoscopic remission of small bowel and colon lesions in both groups.	1、8、24 weeks after intervention
Changes in inflammatory biomarkers (C-reactive protein, fecal calreticulin) in both groups	Assess the changes in inflammatory biomarkers (C-reactive protein, fecal calreticulin) in both groups.	1、4、8、12、24 weeks after intervention
Adverse events and serious adverse events, safety and tolerability, with treatment-related adverse events and number of occurrences as assessed by CTCAE v5.0	Adverse events and serious adverse events, safety and tolerability, with treatment-related adverse events and number of occurrences as assessed by CTCAE v5.0.	1、4、8、12、24 weeks after intervention

Collaborators and Investigators

• Sponsor: Ping An
• Investigators: Principal Investigator: Ping An, Renmin Hospital of Wuhan University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: March 24, 2024
• First Submitted That Met QC Criteria: April 9, 2024
• First Posted (Actual): April 12, 2024

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Crohn's disease; enteral nutrition
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: WDRY2024-K027

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No