Dietary Supplements

Bowel Stimulation Before Loop Ileostomy Closure Using Probiotics: Study Protocol for a Randomized Controlled Trial at a Single Center.

TL;DR

This paper describes the protocol for a randomized controlled trial to evaluate whether probiotic bowel stimulation through the distal limb of a diverting ileostomy before closure is safe, feasible, and efficacious for improving postoperative bowel function and reducing low anterior resection syndrome severity in rectal cancer patients.

Key Findings

The trial targets adults aged 18-80 with clinical stage II or III rectal adenocarcinoma who completed neoadjuvant chemoradiotherapy and underwent laparoscopic or robotic low anterior resection with total mesorectal excision and diverting ileostomy.

  • Participants must be scheduled for elective ileostomy closure to be eligible.
  • The study will be conducted at Keimyung University Dongsan Medical Center, Republic of Korea.
  • Participants are randomized in a 1:1 ratio to intervention or control arms.
  • The study was approved by the Institutional Review Board (DSMC-2024-03-016) and registered with the Clinical Research Information Service (KCT0011052).

The intervention consists of 250 mL of normal saline with 4 g of Lacidofil (a probiotic) administered via the distal limb of the ileostomy once daily for 2 weeks before closure, compared to 250 mL of normal saline alone.

  • Administration is through the distal limb of the diverting ileostomy.
  • The duration of the intervention is 2 weeks prior to ileostomy closure.
  • Lacidofil is the specific probiotic formulation selected for use.
  • The control arm receives normal saline alone under the same administration conditions.

The primary outcome measure is the LARS (Low Anterior Resection Syndrome) score assessed 3 months after ileostomy closure.

  • LARS is described as including urgency, frequent bowel movements, clustering, and fecal incontinence.
  • LARS is identified as a common functional problem after sphincter-preserving rectal cancer surgery.
  • The 3-month post-closure timepoint was chosen as the primary assessment.
  • Analyses will primarily follow the intention-to-treat principle.

Secondary outcomes include postoperative complications, bowel recovery, stool habits, laboratory findings, and length of hospital stay after ileostomy closure.

  • The secondary outcomes are designed to assess both safety and functional recovery.
  • Laboratory findings are included to evaluate systemic effects of the probiotic intervention.
  • Bowel recovery and stool habits are included to characterize functional restoration of the defunctionalized bowel segment.

Diverting ileostomy is noted to disrupt the intestinal environment and alter the gut microbiota, potentially worsening bowel dysfunction after ileostomy closure.

  • The defunctionalized distal bowel segment during ileostomy diversion is identified as a key factor in microbiota disruption.
  • Evidence is described as 'limited' on whether bowel stimulation with probiotics before closure can improve outcomes.
  • The rationale for probiotic stimulation is to restore the intestinal environment of the defunctionalized segment prior to restoration of continuity.

Recruitment is planned to begin in March 2026 and continue through March 2029, with results expected to be published in 2029.

  • At the time of manuscript submission, the study is in the pre-enrollment stage with no participants recruited and no data analysis performed.
  • The trial is registered with the Clinical Research Information Service (KCT0011052).
  • This is a single-center trial.

What This Means

This paper describes the design of a clinical trial, not yet started, that will test whether giving probiotics directly into the inactive portion of the bowel before a temporary ostomy is closed can improve bowel function in rectal cancer patients. When patients with rectal cancer have surgery, surgeons sometimes create a temporary loop ileostomy — a diversion that allows part of the bowel to rest and heal. When this temporary ostomy is closed, the previously inactive bowel segment must resume normal function, but patients often experience significant bowel problems collectively called Low Anterior Resection Syndrome (LARS), which includes symptoms like urgency, frequent bowel movements, clustering of stools, and fecal incontinence. The researchers hypothesize that flushing probiotics into the inactive bowel segment daily for two weeks before closure might help restore a healthier gut environment and reduce these symptoms. The trial will randomly assign eligible patients to receive either a probiotic solution (Lacidofil mixed in saline) or saline alone, delivered once daily through the ileostomy for two weeks before it is surgically closed. The main outcome researchers will track is the LARS score — a validated measure of bowel dysfunction — at three months after the ostomy is closed. They will also track complication rates, bowel recovery speed, stool habits, lab values, and hospital stay length. The study will be conducted at a single hospital in South Korea, with enrollment planned from 2026 to 2029. This research suggests that a simple, low-risk intervention delivered during the waiting period before ostomy closure could potentially make a meaningful difference in quality of life for rectal cancer survivors. Because LARS affects a large proportion of patients after this type of surgery and significantly impacts daily life, finding effective prevention strategies is an important clinical priority. This trial will provide prospective evidence on whether probiotic bowel stimulation is both safe and effective, filling a current gap in the medical literature.

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Citation

Kim K, Bae S, Baek S, Jeong W. (2026). Bowel Stimulation Before Loop Ileostomy Closure Using Probiotics: Study Protocol for a Randomized Controlled Trial at a Single Center.. JMIR research protocols. https://doi.org/10.2196/87422