- 2025-04-17
- United European gastroenterology journal 13(6)
- Jian Kang
- Jing Wang
- Juan Su
- Wei Wang
- Yueyue Lu
- Zhishun Tang
- Liping Zou
- Anning Yin
- Jiao Li
- Haixia Ren
- Qian Zhou
- Huipeng Wan
- Ping An
Study Design
- Type
- Randomized Controlled Trial (RCT)
- Sample size
- n = 43
- Population
- 147 eligible patients with actively moderate-to-severe Crohn's disease treated with biologics and concomitant 16-week EEN
- Methods
- Prospective, single-center randomized clinical trial; patients with EEND received pancreatic enzyme replacement therapy (PERT) or not
- Blinding
- Open-label
- Duration
- 16 weeks
- Funding
- Unclear
Background & aims
Previous results showed that combined treatment of biologics and exclusive enteral nutrition (EEN) brought moderate-to-severe Crohn's disease patients significant improvements in clinical and endoscopic outcomes. Despite its essential role and favorable safety profile, EEN in the treatment of adult Crohn's disease is frequently underestimated because of lower compliance and several side effects, including EEN-related diarrhea (EEND).Methods
In this prospective, single-center randomized clinical trial, 147 eligible patients with actively moderate-to-severe Crohn's disease treated with biologics and concomitant 16-week EEN were included. Sixty-one patients without EEND were enrolled in the ND group (without EEN-related diarrhea), and other patients with EEND who received pancreatic enzyme replacement therapy (PERT) (43 patients) or not (43 patients) were recruited in PERT and NPERT groups, respectively. The clinical outcomes, biologic outcomes, and endoscopic outcomes were evaluated. Quality of life (QoL) and psychological status were also assessed at baseline and endpoints (week 16).Results
Bowel movements (daily frequency decreased by 5.3 times) and stool consistency (reduced watery and loose stool) were greatly improved in PERT group at week 16. At week 16, patients in the ND and PERT groups achieved similar clinical responses (93% in ND group and 94.7% in PERT group, p = 0.731) and clinical remission (86.0% in ND group and 86.8% in PERT group, p = 0.90) while patients in the NPERT group had significantly lower proportions of these clinical outcomes (67.9% clinical response and 57.1% clinical remission). No significant difference was observed in endoscopic outcomes between each group (p = 0.904). QoL and mental status including anxiety and depression in PERT group had great improvement compared with the NPERT group.Conclusions
Our prospective results provided invaluable evidence that PERT supplementation efficiently improved EEND in Crohn's disease patients with combined treatment of biologics and 16-week EEN, which had a promising effect in active Crohn's disease induction.Trial registration
ChiCTR2200058343.