Center for Functional Gastrointestinal and Motility Disorders, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
Glycom A/S, Horsholm, Denmark.
Clin Transl Gastroenterol. 2020 Dec;11(12):e00276. doi: 10.14309/ctg.0000000000000276.
Treatment options for irritable bowel syndrome (IBS) are limited, causing many patients to remain symptomatic. This study assessed the potential of human milk oligosaccharides (HMOs) to normalize bowel habits. Secondary outcomes included IBS severity and health-related quality of life.
This multicenter, open-label trial recruited patients with IBS from 17 sites across the United States. Patients received daily orally administrated 5-g intervention of the HMOs 2'-fucosyllactose and lacto-N-neotetraose in a 4:1 mix. Bowel habits, IBS symptoms, and quality of life were assessed at baseline and every 4 weeks during the 12-week intervention.
A total of 317 patients (70.7% women; mean age of 44.0 years, range 18-93 years) received the trial product, and 245 patients completed the trial according to protocol. Patients had a significant improvement from baseline to 12 weeks in total percentage of bowel movements with abnormal stool consistency (mean and [95% confidence interval]: 90.7 [88.9-92.9] vs 57.2% [53.9-60.5], P < 0.0001), overall IBS Symptom Severity Score (323 [314-332] vs 144 [133-155], P < 0.0001) and health-rela,ted quality of life (50.4 [48.0-52.8] vs 74.6 [72.3-76.9], P < 0.0001). Improvement was similar across IBS subtypes. Symptoms improved most in the first 4 weeks of intervention. The most common side effects were mild gastrointestinal symptoms such as flatulence, abdominal pain and discomfort, and distension.
Supplementation with 2 selected HMOs improves IBS symptoms and quality of life without substantial side effects. These promising results suggest that this novel approach to IBS should be confirmed in a randomized, placebo-controlled trial.
肠易激综合征（IBS）的治疗选择有限，导致许多患者仍有症状。本研究评估了人乳寡糖（HMOs）使肠道习惯正常化的潜力。次要结局包括 IBS 严重程度和与健康相关的生活质量。
这项多中心、开放标签试验在美国 17 个地点招募了 IBS 患者。患者每天口服接受 5 克干预，即 2'-岩藻糖基乳糖和乳糖-N-新四糖以 4:1 的比例混合。在 12 周的干预期间，在基线时和每 4 周评估肠道习惯、IBS 症状和生活质量。
共有 317 名患者（70.7%为女性；平均年龄为 44.0 岁，范围为 18-93 岁）接受了试验产品，245 名患者按照方案完成了试验。与基线相比，患者在 12 周时总排便异常粪便稠度的百分比有显著改善（平均值和 [95%置信区间]：90.7 [88.9-92.9]%对 57.2% [53.9-60.5]%，P < 0.0001），总体 IBS 症状严重程度评分（323 [314-332] 对 144 [133-155]，P < 0.0001）和健康相关的生活质量（50.4 [48.0-52.8] 对 74.6 [72.3-76.9]%，P < 0.0001）。IBS 亚型的改善情况相似。干预的前 4 周症状改善最明显。最常见的副作用是轻度胃肠道症状，如胀气、腹痛和不适以及腹胀。
补充 2 种选定的 HMOs 可改善 IBS 症状和生活质量，而无明显副作用。这些有希望的结果表明，这种治疗 IBS 的新方法应在随机、安慰剂对照试验中得到证实。
