当前位置: X-MOL 学术J. Clinical Gastroenterol. › 论文详情
Our official English website, www.x-mol.net, welcomes your feedback! (Note: you will need to create a separate account there.)
An Open-label, Multicenter Study to Assess the Efficacy and Safety of a Novel Probiotic Blend in Patients With Functional Gastrointestinal Symptoms
Journal of Clinical Gastroenterology ( IF 2.9 ) Pub Date : 2022-05-01 , DOI: 10.1097/mcg.0000000000001567
Lucinda A Harris 1 , Brooks D Cash 2 , Karim Moftah 3 , Howard Franklin 4
Affiliation  

Goal: 

A novel 5-strain (Bl-04, Bi-07, HN019, NCFM, and Lpc-37) probiotic blend was developed and its safety and efficacy were evaluated in patients with functional gastrointestinal (GI) symptoms.

Background: 

These strains administered together have not previously been investigated.

Study: 

Patients aged 18 to 75 years with functional GI symptoms were eligible for inclusion in a single-arm, open-label, multicenter study (NCT04155801). An oral capsule containing the novel probiotic blend was administered once daily for 30 days. The primary efficacy endpoint was patient-reported improvement in overall GI well-being at day 30. Secondary efficacy endpoints included changes in GI symptoms assessed using the GI Health Symptom Questionnaire. Incidence of treatment-emergent adverse events was recorded at all visits.

Results: 

Of 188 enrolled patients, 72.3% were female and mean (SD) age was 44.1 (13.4) years. At day 30, 85.1% of patients achieved the primary endpoint, a positive response signifying improvement in overall GI well-being. Improvements from baseline were reported at day 30 in diarrhea frequency (baseline frequency≥3 to 4 d/wk) and severity (baseline severity≥5/10) for 75.8% and 87.3% of patients, respectively. Over the same time period, constipation frequency (baseline frequency≥3 to 4 d/wk) and severity (baseline severity≥5/10) improved in 73.6% and 80.4% of patients, respectively. Most patients reported improvements at day 30 in frequency and severity of straining, urgency, abdominal pain/discomfort, bloating, and distention. Improvements reported at day 30 were generally observable at day 14. No safety signals were identified.

Conclusion: 

A novel 5-strain probiotic blend improved functional GI symptoms and was safe.



中文翻译:

一项开放标签、多中心研究,旨在评估新型益生菌混合物对功能性胃肠道症状患者的功效和安全性

目标: 

开发了一种新型 5 株(Bl-04、Bi-07、HN019、NCFM 和 Lpc-37)益生菌混合物,并在患有功能性胃肠道 (GI) 症状的患者中评估了其安全性和有效性。

背景: 

之前尚未对这些一起施用的菌株进行过研究。

学习: 

年龄在 18 岁至 75 岁之间、有功能性胃肠道症状的患者有资格参加一项单臂、开放标签、多中心研究 (NCT04155801)。每天一次服用含有新型益生菌混合物的口服胶囊,持续 30 天。主要疗效终点是患者报告的第 30 天时胃肠道整体健康状况的改善。次要疗效终点包括使用胃肠道健康症状问卷评估的胃肠道症状的变化。每次就诊时均记录治疗引起的不良事件的发生率。

结果: 

在 188 名入组患者中,72.3% 为女性,平均 (SD) 年龄为 44.1 (13.4) 岁。第 30 天时,85.1% 的患者达到了主要终点,即阳性反应,表明整体胃肠道健康状况有所改善。第 30 天时,75.8% 和 87.3% 的患者的腹泻频率(基线频率≥3 至 4 天/周)和严重程度(基线严重程度≥5/10)较基线有所改善。同一时期内,73.6% 和 80.4% 的患者便秘频率(基线频率≥3 至 4 天/周)和严重程度(基线严重程度≥5/10)分别得到改善。大多数患者报告第 30 天时用力、尿急、腹痛/不适、腹胀和腹胀的频率和严重程度有所改善。第 30 天报告的改善通常在第 14 天即可观察到。未发现任何安全信号。

结论: 

一种新型 5 株益生菌混合物改善了功能性胃肠道症状并且是安全的。

更新日期:2022-05-02
down
wechat
bug