Departments of Pediatrics, Shengjing Hospital of China Medical University, Shenyang, China.
Department of General Surgery, Shengjing Hospital of China Medical University, Shenyang, China .
Am J Gastroenterol. 2024 Nov 1;119(11):2288-2297. doi: 10.14309/ajg.0000000000002958. Epub 2024 Jul 11.
Management of intractable childhood constipation is still challenging. The efficacy of retrograde colonic enema (RCE) with fecal microbiota transplantation (FMT) in intractable childhood constipation has not been established, although both have demonstrated potential in gastrointestinal diseases. The aim of this study was to determine the safety and efficacy of RCE-based FMT in the treatment of intractable constipation in children.
A randomized, double-blind, controlled trial with 110 children was conducted. The patients were randomly assigned to the FMT with RCE group or the placebo with RCE group. All participants received a daily RCE, followed by a 4-week FMT treatment (twice a week) and a 12-week follow-up period. Spontaneous bowel movements ≥ 3 per week were the main outcomes, and the risk ratio with 95% confidence interval (CI) was calculated. Changes in intestinal bacterial profile were analyzed by BOX-PCR-based DNA fingerprinting and sequencing. The adverse effects were assessed based on symptoms.
At the end of the follow-up period, 22 patients (40.0%) in the FMT with RCE group and 10 patients (18.2%) in the placebo with RCE group had ≥ 3 spontaneous bowel movements per week (net difference = 21.8%, 95% CI: 13.2%-30.4%; risk ratio: 1.364, 95% CI: 1.063-1.749; P < 0.05). Both RCE and FMT enriched the intestinal bacterial diversity of patients with constipation. The adverse events were all mild self-limiting gastrointestinal symptoms.
FMT enhances the efficacy of RCE, and the use of RCE-based FMT is a safe and effective method in the treatment of intractable constipation in children.
儿童难治性便秘的治疗仍然具有挑战性。尽管粪便微生物群移植（FMT）和逆行结肠灌洗（RCE）在胃肠道疾病中均显示出一定的疗效，但它们在儿童难治性便秘中的疗效尚未得到证实。本研究旨在确定基于 RCE 的 FMT 治疗儿童难治性便秘的安全性和有效性。
采用随机、双盲、对照临床试验，共纳入 110 例患儿。患儿被随机分配至 FMT+RCE 组或安慰剂+RCE 组。所有参与者均接受每日 RCE 治疗，随后进行为期 4 周的 FMT 治疗（每周 2 次）和 12 周的随访。主要结局为每周自发排便≥3 次，计算风险比及其 95%置信区间（CI）。采用 BOX-PCR 基于 DNA 指纹图谱和测序分析肠道细菌谱的变化。根据症状评估不良反应。
随访期末，FMT+RCE 组 22 例（40.0%）患儿和安慰剂+RCE 组 10 例（18.2%）患儿每周自发排便≥3 次（净差值=21.8%，95%CI：13.2%-30.4%；风险比：1.364，95%CI：1.063-1.749；P＜0.05）。RCE 和 FMT 均增加了便秘患儿肠道细菌的多样性。所有不良反应均为轻微的自限性胃肠道症状。
FMT 增强了 RCE 的疗效，基于 RCE 的 FMT 是治疗儿童难治性便秘的一种安全有效的方法。
