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

NCT06362863 | Not Yet Recruiting

• 1 other identifier: WDRY2024-K027
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Crohn's Disease

Keywords

enteral nutrition; Crohn's disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Induced remission success rate

  2、4、8、12、24 weeks after intervention

• Gastrointestinal Symptom Rating Scale (GSRS) score

  2、4、8、12、24 weeks after intervention

• Gastrointestinal symptom remission

  4 weeks after intervention

• 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

  1、8、24 weeks after intervention

Study Arms (2)

Enteral nutrition biscuits

EXPERIMENTAL

Addition of enteral nutritional biscuits to existing pharmacological treatment.

Dietary Supplement: enteral nutrition biscuits

Conventional drug therapy

NO INTERVENTION

No nutritional intervention, use of existing medication.

Interventions

enteral nutrition biscuits DIETARY_SUPPLEMENT

Addition of enteral nutritional biscuits to existing pharmacological treatment.

Enteral nutrition biscuits

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Ping An: lead

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Ping An

  Renmin Hospital of Wuhan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ping An

CONTACT

+8618627068700; anping_05@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: This is a prospective randomized controlled study divided into intervention and control groups.

Study Record Dates

• First Submitted: March 24, 2024
• First Posted: April 12, 2024
• Study Start: June 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 12, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share