Enrolling by invitation NCT07171593
High-protein Oral Nutrition With HMB for Active CD Patients With Sarcopenia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HMB.
- Who it may be relevant to
- Registry conditions: Handgrip Strength. Basic parameters: 18 years — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Efficacy of High-protein Oral Enteral Nutrition Supplement Supplemented With HMB in Active Crohn's Disease With Sarcopenia: a Prospective, Randomized, Controlled Study
Overview
The efficacy of B-hydroxy-β-methybutyrate in sarcopenia
Interventions
- Dietary supplement HMB
EEN+HMB
Primary outcome measures
- muscle strength improvement [Time frame: Week 4; Week 8]
Secondary outcome measures (5)
- Improvement of muscle mass [Time frame: Week 4; Week 8]
- Clinical response [Time frame: Week 4; Week 8]
- Clinical remission [Time frame: Week 4; Week 8]
- Mucosal healing [Time frame: Week 4; Week 8]
- Clinical relapse [Time frame: Week 4; Week 8]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Sixth Hospital Affiliated to Sun Yat-sen University — Guangzhou
Identifiers
NCT: NCT07171593 · 2023-077