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.

The PHGG-enriched enteral formula demonstrated non-inferiority to the standard fiber-free formula in terms of diarrhea incidence following GI surgery.

• Diarrhea incidence was 9.6% (95% CI: 6.3 to 12.8) in the experimental group and 10.1% (95% CI: 6.8 to 13.4) in the control group.
• The absolute difference in diarrhea incidence was -0.5 (95% CI: -5.1 to 4.2), confirming non-inferiority (P < 0.001).
• 631 patients were enrolled and randomized: experimental group n = 313, control group n = 318.
• Participants received either 15 g/L PHGG-enriched formula or standard fiber-free formula for 5 days.

In patients consuming at least 4500 kcal over 5 days, the PHGG-enriched formula significantly reduced the prevalence of diarrhea and abdominal distension compared to the fiber-free formula.

• Among patients consuming ≥4500 kcal over 5 days (averaging 900 kcal/day), diarrhea prevalence was 10.4% vs 24.7% (P = 0.045) favoring the experimental group.
• Abdominal distension prevalence was 19.4% vs 38.4% (P = 0.016) favoring the experimental group in this subgroup.
• This subgroup analysis suggests a threshold of 800-900 kcal/day to maximize GI tolerance benefits.

Patients with gastric cancer in the PHGG experimental group had significantly less abdominal distension compared to the control group.

• Abdominal distension prevalence in gastric cancer patients was 22.7% in the experimental group vs 48.8% in the control group (P = 0.014).
• This finding was specific to the gastric cancer subgroup within the broader GI surgery population.

The PHGG-enriched formula demonstrated benefits in body weight preservation at hospital discharge.

• Percent weight change at discharge was -1.39 in the experimental group vs -2.33 in the control group (P = 0.049).
• The experimental group showed statistically significantly less weight loss compared to the fiber-free control group.

Patients receiving the PHGG-enriched formula had better quality of life scores 30 days after surgery, particularly in pain/discomfort and anxiety dimensions.

• EQ-5D scores were better in the experimental group at 30 days post-surgery.
• Improvements were specifically noted in E4 (pain/discomfort) and E5 (anxiety/depression) dimensions of the EQ-5D instrument.
• Quality of life was assessed 30 days following GI surgery as a clinical outcome measure.

The study was designed as a prospective, multicenter, open-label, randomized controlled non-inferiority trial enrolling malnourished or nutritionally at-risk patients following gastrointestinal surgery.

• 631 patients requiring enteral nutrition following GI surgery were enrolled across multiple centers in China.
• The trial protocol was registered at www.chictr.org.cn (Identifier: ChiCTR2000038429).
• The intervention period was 5 days, with follow-up data collected at discharge and 30 days post-surgery.
• The experimental formula contained 15 g/L of partially hydrolyzed guar gum (PHGG), described as a soluble, prebiotic dietary fiber.