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The exploration of therapeutic strategies after exclusive enteral nutrition for refractory penetrating Crohn's disease: a single center, prospective, single arm study

The exploration of therapeutic strategies after exclusive enteral nutrition for refractory penetrating Crohn's disease: a single center, prospective, single arm study

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400094819
Enrollment
Unknown
Registered
2024-12-27
Start date
2024-08-15
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

Crohn's disease

Interventions

Test Group:early enteral nutrition

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Patients deemed capable of understanding and complying with the protocol requirements and signing informed consent by the investigators. 2.Patients aged between 18 and 65 years old. 3.Diagnosis of Crohn's disease (CD) based on CD diagnostic criteria combined with clinical presentation, imaging, endoscopy, and pathology reports. Patients must have been diagnosed with CD for at least 3 months before screening. For cases diagnosed with CD at least 6 months prior to enrollment and unable to obtain tissue pathology reports, diagnostic weighting based on diagnostic criteria will be considered, and other possible diagnoses will be excluded. The diagnosis of CD will be confirmed after discussion by the inflammatory bowel disease multidisciplinary team (IBD MDT) before patient enrollment. 4. Patients with penetrating CD present with one of the following conditions: (1) Multiple or multiloculated abscesses, refractory abdominal or pelvic abscesses, or large intra-abdominal abscesses (>3cm) that cannot be drained by catheter placement. (2) Failure of catheter drainage in intra-abdominal abscesses. (3) Complications following abdominal wall abscess drainage surgery.

Exclusion criteria

Exclusion criteria: 1.Patients experiencing serious adverse events prompting the physician to discontinue enteral nutrition, medication, or surgical interventions. 2.Modification or termination of the original treatment regimen. 3.Loss to follow-up. 4.Pregnant participants during the trial.

Design outcomes

Primary

MeasureTime frame
Crohn's Disease Activity Index;Nutritional Risk Screening 2002;CRP;ESR;WBC;ALB;HB;inflammatory bowel disease questionnaire of quality of life;

Secondary

MeasureTime frame
Complications;Clinical presentation;

Countries

China

Contacts

Public ContactMeng Wenjian

Colorectal Cancer Center, Department of General Surgery, West China Hospital

mengwenjian@126.com+86 189 8060 6727

Outcome results

None listed

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