Tolerability and efficacy of an enteral formula containing partially hydrolyzed guar gum in patients following gastrointestinal surgery: A prospective, multicenter, open-label, randomized controlled study.

[BACKGROUND AND AIMS] Malnourished patients, who undergo gastrointestinal (GI) surgery, have a higher risk of postoperative complications, including higher rates of morbidity and mortality. Generally, a low-fiber diet is recommended after GI surgery. This study investigated the tolerance and clinical outcomes of an enteral formula supplemented with partially hydrolyzed guar gum (PHGG)-a soluble, prebiotic dietary fiber known to benefit gastrointestinal health-in Chinese patients following GI surgery, using a standard fiber-free formula as the control..

[METHODS] This study enrolled 631 patients requiring enteral nutrition following GI surgery. Participants were subsequently randomized to receive either a fiber-enriched formula containing 15 g/L PHGG (experimental group, n = 313) or a standard fiber-free formula (control group, n = 318) for 5 days. Data on feeding effectiveness, tolerability, and clinical outcomes were subsequently collected.

[RESULTS] The incidence of diarrhea was 9.6 % (95 % confidence interval [CI]: 6.3 to 12.8) in the experimental group and 10.1 % (95 % CI: 6.8 to 13.4) in the control group, with an absolute difference of -0.5 (95 % CI: -5.1 to 4.2) confirming non-inferiority (P < 0.001). In patients who consumed ≥4500 kcal over 5 days (averaging 900 kcal/day), the experimental group showed significantly improved feeding tolerance, with a reduced prevalence of diarrhea and abdominal distension (10.4 % vs 24.7 %, P = 0.045; 19.4 % vs 38.4 %, P = 0.016). Patients with gastric cancer in the experimental group had significantly less abdominal distension (22.7 % vs 48.8 %; P = 0.014). Regarding weight preservation, the experimental group demonstrated benefits in weight preservation at discharge (%weight change: -1.39 vs -2.33, P = 0.049). Thirty days after surgery, the experimental group had better EQ-5D scores, especially in E4 pain/discomfort and E5 anxiety.

[CONCLUSIONS] The PHGG-enriched enteral nutrition formulation is well-tolerated and non-inferior to a fiber-free formula among patients following GI surgery. To maximize its benefits on GI tolerance and body weight preservation, a daily intake of 800-900 kcal is suggested, though this warrants further validation. The trial protocol was registered at www.chictr.org.cn (Identifier: ChiCTR2000038429).