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

Crohn's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06362863
• Other study ID #: WDRY2024-K027
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: Renmin Hospital of Wuhan University
• Contact: Ping An
• Phone: +8618627068700
• Email: anping_05[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 52
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Dietary Supplement:
• enteral nutrition biscuits
Addition of enteral nutritional biscuits to existing pharmacological treatment.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ping An

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Induced remission success rate	Probability of success of intervention in inducing CD remission.	2?4?8?12?24 weeks after intervention
Secondary	Gastrointestinal Symptom Rating Scale (GSRS) score	Gastrointestinal Symptom Rating Scale (GSRS) score.	2?4?8?12?24 weeks after intervention
Secondary	Gastrointestinal symptom remission	Gastrointestinal Symptom Rating Scale (GSRS) scores after 4 weeks of intervention.	4 weeks after intervention
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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