Food Science and Human Nutrition Department, University of Florida, 572 Newell Dr, Gainesville, FL, 32611, USA.
Lallemand Health Solutions, 6100 Royalmount avenue, Montreal, QC, H4P 2R2, Canada.
Trials. 2022 Jun 10;23(1):481. doi: 10.1186/s13063-022-06410-w.
For many women, uncomfortable and stressful symptoms accompany the menstrual cycle each month, sometimes in a debilitating manner. Previous studies have reported that gastrointestinal symptoms in healthy women significantly differ by the day of the menstrual cycle, but few studies have assessed interventions intended to minimize these symptoms. Probiotics supplements have been shown to attenuate gastrointestinal symptom severity as well as self-reported feelings of stress in various populations. This study evaluates the effect of a probiotic on abdominal pain and gastrointestinal symptoms in healthy women who take an oral contraceptive, have regular menses, and typically experience these symptoms during menstruation with the primary aim being change in abdominal pain intensity related to the menstrual cycle with probiotic versus placebo supplementation.
In this randomized, double-blind, placebo-controlled parallel study, participants will receive either a probiotic or placebo supplement. Participants will begin answering questionnaires approximately 7 days before the start of menstruation (i.e., active bleeding), and 3 days later, they will begin consuming the study supplement for 8 weeks. The questionnaires administered will collect data about abdominal pain severity (primary outcome) and duration related to the menstrual cycle, digestive health, dietary intake, stress, and digestion-associated quality-of-life. A subgroup of women will provide weekly vaginal swabs and stool samples to examine the effect of the probiotic supplement on microbiota composition and diversity for exploratory purposes. Two-sided tests using a linear model and a type I error rate of α = 0.05 will be employed to test all hypotheses. Continuous variables will be presented as means with standard errors and categorical variables, as counts or proportions.
This study was reviewed and approved by the University of Florida Institutional Review Board 01. Written informed consent will be obtained from all participants prior to any study activities. Study findings will be disseminated at scientific conferences and publication in the trial registry or in a peer-reviewed journal. Any protocol amendments will be reported in the final manuscript of this study.
ClinicalTrials.gov NCT04457401 . Registered prospectively on 07 July 2020. The trial was completed in December of 2021.
V4.0 (11-04-2020) TRIAL STATUS: Currently recruiting. Recruitment began in November 2020 and extend until December 2021.
对于许多女性来说，每个月的月经周期都会伴随一些不适和压力症状，有时这些症状甚至会使人虚弱。先前的研究报告称，健康女性的胃肠道症状在月经周期的不同天数有显著差异，但很少有研究评估旨在减轻这些症状的干预措施。益生菌补充剂已被证明可减轻胃肠道症状的严重程度以及各种人群的自我报告压力感。本研究评估了益生菌对服用口服避孕药、月经规律且通常在月经期间出现这些症状的健康女性的腹痛和胃肠道症状的影响，主要目的是改变与益生菌与安慰剂补充剂相关的月经周期腹痛强度。
在这项随机、双盲、安慰剂对照的平行研究中，参与者将接受益生菌或安慰剂补充剂。参与者将在月经开始前约 7 天（即活跃出血）开始回答问卷，3 天后，他们将开始服用研究补充剂 8 周。管理的问卷将收集与月经周期相关的腹痛严重程度（主要结局）和持续时间、消化健康、饮食摄入、压力和与消化相关的生活质量的数据。一小部分女性将每周提供阴道拭子和粪便样本，以探索益生菌补充剂对微生物群组成和多样性的影响。将使用线性模型和 α = 0.05 的Ⅰ型错误率进行双侧检验来测试所有假设。连续变量将以平均值和标准误差表示，分类变量将以计数或比例表示。
本研究已由佛罗里达大学机构审查委员会审查和批准，01。在进行任何研究活动之前，将从所有参与者处获得书面知情同意。研究结果将在科学会议上公布，并在试验注册处或同行评议期刊上发表。任何方案修正案将在本研究的最终手稿中报告。
ClinicalTrials.gov NCT04457401。于 2020 年 7 月 07 日进行前瞻性注册。试验于 2021 年 12 月完成。
V4.0（2020 年 11 月 04 日）试验状态：正在招募。招募于 2020 年 11 月开始，并持续到 2021 年 12 月。
