Status:
ENROLLING_BY_INVITATION
High-protein Oral Nutrition With HMB for Active CD Patients With Sarcopenia
Lead Sponsor:
Sixth Affiliated Hospital, Sun Yat-sen University
Conditions:
Handgrip Strength
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
The efficacy of B-hydroxy-β-methybutyrate in sarcopenia
Eligibility Criteria
Inclusion
- Patients with active Crohn's disease (CD) who visited the Sixth Affiliated Hospital of Sun Yat-sen University between July 2023 and December 2024;
- Aged 18-50 years;
- Complicated with sarcopenia;
- Willing and able to tolerate oral exclusive enteral nutrition (EEN) therapy;
- Signed informed consent and able to comply with the study procedures;
- Colonic or ileocolonic type CD (SES-CD ≥6; if only terminal ileum is involved, SES-CD ≥4).
Exclusion
- Short bowel syndrome;
- High-output jejunal fistula;
- Severe stress or shock status;
- Complete mechanical intestinal obstruction, acute gastrointestinal bleeding, or severe intra-abdominal infection;
- Severe hepatic, renal, or cardiac diseases, or malignant tumors;
- History of allergy or contraindication to Ensure or HMB;
- Persistent severe vomiting or intractable diarrhea;
- Congenital disorders of sugar or amino acid metabolism;
- Underwent CD-related intestinal surgery or received biologic therapy within the past month, or received immunosuppressive/antibiotic therapy related to CD within 2 weeks prior to enrollment.
Key Trial Info
Start Date :
March 4 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT07171593
Start Date
March 4 2024
End Date
December 1 2026
Last Update
September 12 2025
Active Locations (1)
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1
Sixth Hospital Affiliated to Sun Yat-sen University
Guangzhou, Guangdong, China, 570000