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

P

Ping An

Status

Begins enrollment this month

Conditions

Crohn's Disease

Treatments

Dietary Supplement: enteral nutrition biscuits

Study type

Interventional

Funder types

Other

Identifiers

NCT06362863
WDRY2024-K027

Details and patient eligibility

About

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.

Full 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.

Enrollment

52 estimated patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

52 participants in 2 patient groups

Enteral nutrition biscuits
Experimental group
Description:
Addition of enteral nutritional biscuits to existing pharmacological treatment.
Treatment:
Dietary Supplement: enteral nutrition biscuits
Conventional drug therapy
No Intervention group
Description:
No nutritional intervention, use of existing medication.

Trial contacts and locations

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Central trial contact

Ping An

Data sourced from clinicaltrials.gov

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