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Study on the efficacy and safety of pancreatic enzyme replacement therapy for total enteral nutrition-related diarrhea in moderately to severely active Crohn's disease

Study on the efficacy and safety of pancreatic enzyme replacement therapy for total enteral nutrition-related diarrhea in moderately to severely active Crohn's disease

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400086621
Enrollment
Unknown
Registered
2024-07-08
Start date
2024-07-10
Completion date
Unknown
Last updated
2024-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn’s disease

Interventions

Pancreatin intervention group:The dosage of Creon (trypsin enteric-coated capsule) (according to the drug instruction manual): 1 tablet every time, once every 2 hours, 6 times a day, and then stop tak
Control group:Treat according to routine procedure. The control group did not receive trypsin replacement therapy

Sponsors

Department of Gastroenterology, Renmin Hospital of WuhanUniversity
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: A) The age ranges from 18 to 70 years old; B) According to the consensus opinion on diagnosis and treatment of inflammatory bowel disease (2018), CD diagnosis points (imaging endoscopy and biopsy characteristics and clinical manifestations) were recommended; C) Crohn's disease activity index CDAI > 220; D) Nutrition risk screening score summary table (NRS-2022) with malnutrition risk score > 3 points; E) Being or being treated with biological agents such as immunomodulators; F) No postoperative intestinal fistula; G) No diarrhoea due to other diseases; H) Voluntary consent to participate in the study

Exclusion criteria

Exclusion criteria: (A) Symptoms of diarrhoea; B) Symptoms of intestinal obstruction; C) Patients who have had a history of surgery in the past 6 months or have recently undergone digestive surgery ( 2) occurred within 4 weeks before the start of the study; J) Patients with severe gastrointestinal problems (such as life-threatening intestinal obstruction and perforation) requiring immediate treatment; K) Suffering from underlying diseases that affect treatment; L) Pregnant or lactating women; M) Positive for human immunodeficiency virus; n) Known history of active pulmonary tuberculosis Subjects suspected of active pulmonary tuberculosis should be examined for chest X-ray sputum and excluded by clinical symptoms and signs; O) Untreated chronic hepatitis B patients or hepatitis B virus carriers with chronic hepatitis B virus DNA exceeding 500 IU/ml or active hepatitis C patients should be excluded Inactive HBsAg carriers, stable and treated hepatitis B patients (HBV DNA < 500 IU/ml) and cured hepatitis C patients can be enrolled in the group Subjects with positive hepatitis C virus antibody are eligible to participate in the study only if the HCV RNA test results are negative; P) Known history of psychotropic substance abuse, alcohol abuse and drug abuse; Q) Any situation where the researcher believes that participants should be excluded from the study

Design outcomes

Primary

MeasureTime frame
Mitigation rates for EEND;

Secondary

MeasureTime frame
Pancreatic elastase 1 level;Crohn’s disease activity index, CDAI;Quality of life score;Sleep quality score;EEN compliance score;

Countries

China

Contacts

Public ContactPING AN

Department of Gastroenterology, Renmin Hospital of WuhanUniversity

anping_05@163.com+86 186 2706 8700

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026