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The Effects of Postbiotic Supplementation in Female Athletes (GIJane)

2026年5月29日 更新者：SPSKJOHN@ljmu.AC.UK、Liverpool John Moores University

The Effect of Daily Supplementation With Humiome® Post LB on Gastrointestinal Symptoms in Female Athletes. A Double-blinded Randomised Controlled Trial.

The goal of this clinical trial is to learn if a postbiotic supplement can reduce stomach and gut symptoms in physically active women.

The main questions it aims to answer are:

Does the supplement reduce gut symptoms during the menstrual cycle? Does it improve symptoms related to exercise?

Researchers will compare the postbiotic supplement to a placebo (a look-alike capsule that contains no active ingredient) to see if the supplement works.

Participants will be physically active, premenopausal female athletes.

Participants will:

Take either the postbiotic supplement or a placebo each day for two menstrual cycles Track their menstrual cycle and training Report gut symptoms using regular questionnaires Provide stool samples to assess gut health

This study will help researchers understand whether postbiotic supplements can improve gut health and reduce symptoms that may affect training and performance in female athletes.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

Female athletes commonly report gastrointestinal (gut) symptoms, particularly during exercise and at certain phases of the menstrual cycle. These symptoms can negatively affect comfort, training, and performance. Despite this, there is limited research examining strategies to reduce these symptoms in physically active women.

Postbiotics are non-living microbial products that may support gut health by improving the function of the gut barrier and influencing the gut microbiota. While previous research suggests that similar products may reduce gut symptoms in clinical and general populations, their effects in female athletes, particularly across the menstrual cycle, are not well understood.

This study is a randomized, placebo-controlled clinical trial designed to investigate the effects of daily postbiotic supplementation on gut symptoms in physically active, premenopausal female athletes. Participants will be randomly assigned to receive either a postbiotic supplement (Humiome® Post LB) or a placebo for two consecutive menstrual cycles.

Throughout the study, participants will record gut symptoms using validated questionnaires, with a focus on symptoms experienced during menstruation and across the menstrual cycle. Additional measures will include subtypes of gut symptoms (such as abdominal pain, diarrhoea, and constipation), training behaviour, and stool samples to assess gut microbiota composition and diversity.

The primary aim is to determine whether postbiotic supplementation reduces overall gut symptom severity during menstruation compared to placebo. Secondary analyses will explore changes in specific symptom types, gut microbiota outcomes, and training-related measures.

This research will provide new insight into the role of postbiotic supplementation in supporting gut health in female athletes and may help inform strategies to reduce symptoms that can impact training and performance.

研究类型

介入性

注册 (估计的)

100

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 英国
    • Merseyside
      • Liverpool、Merseyside、英国、L3 3AF
        • 招聘中
        • Tom Reilley Building
        • 接触：
        • 接触：
        • 副研究员：
          • Samanvita Ravikanti, PhDc
        • 副研究员：
          • Maxine Gaivizo, BSc

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

描述

Inclusion Criteria:

  1. Female, cisgender, premenopausal.
  2. Minimum age 18 years.
  3. Regular, natural menstrual cycle (21-35 days in duration), with 9 or more consecutive periods per year, if possible documented with tracker apps, calendars, or other tools
  4. Ability to give informed consent.
  5. Body mass index (BMI) ≥ 18.5 and < 24.9 kg/m²
  6. Agreeing to maintain lifestyle habits during the study (same dietary and physical activity habits)
  7. Having a smartphone and a history of consistent tracking of training and health records via apps.
  8. Having regular GI issues during exercise, and during menstruation. During pre-screening, this will be assessed with a shortened GSRS questionnaire, where participants need to have had, in the month preceding pre-screening, the equivalent of at least a score of 2 in a GSRS focus area (diarrhoea, pain, indigestion).
  9. No relevant self-reported abnormalities from medical history.
  10. Trained athlete (trains at least 3 times per week for more than 1 hour per day and who has been involved in endurance training for at least 2 years in alignment with previous research (Pfeiffer et al., 2010). This will be evaluated by assessing training records (Strava or similar applications, certificates of attendance at athletic events, club membership, etc.).
  11. Access to a health-care provider, who can be contacted by the CRO, and who reside in areas with available emergency health services.

Exclusion Criteria:

  1. Individuals who are pregnant, lactating, or plan to become pregnant before study end.
  2. Individuals with secondary amenorrhea.
  3. Individuals who use hormonal contraceptives during the last 6 months before (and during) the trial.
  4. Individuals who are currently participating in another clinical trial or have participated in a trial within the last two months prior to enrolment.
  5. Tobacco smokers and vapers.
  6. Individuals with acute illnesses.
  7. Individuals with a current musculoskeletal injury or one within the last month.
  8. Individuals taking probiotic supplements or have taken probiotics two weeks prior to enrolment.
  9. Individuals controlling chronic diseases with treatments known to alter the intestinal microbiome or to alter GI symptoms, such as certain pain killers, antacids, proton pump inhibitors, anti-diarrhoeal medication or supplements, and laxatives.
  10. Individuals having received antibiotics treatments within three months of trial start.
  11. Individuals having planned major changes in lifestyle (i.e. diet, weight loss program, exercise level, travelling) during the duration of the study.
  12. Individuals who have hypersensitivity/allergy to any of the components of the test product.
  13. Individuals who have planned major elective surgery during the study period.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：三倍

武器和干预

参与者组/臂
干预/治疗
实验性的：Postbiotic Supplementation
All participants complete a one menstrual cycle placebo run-in phase before randomisation. Participants in this arm then receive the postbiotic supplement daily for two consecutive menstrual cycles.
膳食补充剂：Postbiotic
Postbiotic supplement (Humiome® Post LB) administered as two oral capsules daily, providing 340 mg of postbiotic per day. The supplement contains heat-inactivated microbial strains and fermentation products. Participants will take the supplement daily for two consecutive menstrual cycles following a one-cycle placebo run-in phase.
膳食补充剂：Placebo
Placebo capsules containing microcrystalline cellulose, matched in appearance to the postbiotic supplement. Participants will take two capsules daily during a one-cycle placebo run-in phase and, if randomized to the placebo group, continue for two additional menstrual cycles.
安慰剂比较：Placebo
All participants complete a one menstrual cycle placebo run-in phase before randomisation. Participants in this arm then continue taking placebo daily for two consecutive menstrual cycles.
膳食补充剂：Placebo
Placebo capsules containing microcrystalline cellulose, matched in appearance to the postbiotic supplement. Participants will take two capsules daily during a one-cycle placebo run-in phase and, if randomized to the placebo group, continue for two additional menstrual cycles.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Gastrointestinal Symptom Severity During Menstruation
大体时间：At the post menstruation assessment following completion of cycle 4 ~84-147 days depending on individual cycle and menstruation duration
To assess the effect of daily consumption of Humiome® Post LB (HPLB) on menstrual cycle-related gastrointestinal symptoms (total amended Gastrointestinal Symptom Rating Scale scores; aGSRS) during the final intervention menstrual cycle (Phase 3) in physically active, premenopausal female athletes.
At the post menstruation assessment following completion of cycle 4 ~84-147 days depending on individual cycle and menstruation duration

次要结果测量

结果测量
措施说明
大体时间
Total Gastrointestinal Symptom Rating Scale (GSRS) score assessed weekly across the two intervention menstrual cycles.
大体时间：Weekly from the start of Cycle 2 through completion of Cycle 4 (up to 147 days from baseline; cycles range 21-35 days
To assess the effect of daily consumption of HPLB on menstrual cycle-related gastrointestinal symptoms (GSRS) during the second intervention menstrual cycle (Phase 2) in physically active, premenopausal female athletes, by comparing the HPLB group to the placebo group. This is a 7-point Likert scale with 1 indicating "no discomfort at all" and 7 indicating "very severe discomfort".
Weekly from the start of Cycle 2 through completion of Cycle 4 (up to 147 days from baseline; cycles range 21-35 days
Total Gastrointestinal Symptom Rating Scale Score
大体时间：Weekly from the start of the start of the first intervention cycle (Cycle 2) through completion of the final intervention cycle (Cycle 4), up to 147 days from baseline
Between-group difference (HPLB vs placebo) in total Gastrointestinal Symptom Rating Scale (GSRS) score assessed weekly across the two intervention menstrual cycles. This is a 7-point Likert scale with 1 indicating "no discomfort at all" and 7 indicating "very severe discomfort".
Weekly from the start of the start of the first intervention cycle (Cycle 2) through completion of the final intervention cycle (Cycle 4), up to 147 days from baseline
GSRS Sub-Category Scores
大体时间：Weekly from the start of the start of the first intervention cycle (Cycle 2) through completion of the final intervention cycle (Cycle 4), up to 147 days from baseline
Between-group difference (HPLB vs placebo) in Gastrointestinal Symptom Rating Scale (GSRS) sub-category scores assessed weekly across the two intervention menstrual cycles, including reflux, abdominal pain, indigestion, diarrhoea, and constipation. This is a 7-point Likert scale with 1 indicating "no discomfort at all" and 7 indicating "very severe discomfort".
Weekly from the start of the start of the first intervention cycle (Cycle 2) through completion of the final intervention cycle (Cycle 4), up to 147 days from baseline
Wilson Gastrointestinal Symptom Score
大体时间：Daily during menstruation on Day 1 (±1 day) of Cycle 2 (phase 2), Cycle 3 and Cycle 4 (phase 3). Up to 147 days from baseline.
Between-group difference (HPLB vs placebo) in Wilson Gastrointestinal Symptom scores recorded daily during menstruation across both intervention cycles. Gastrointestinal symptoms will be rated on a 0-10 Likert scale for that day. The scale has descriptors of "no discomfort," "moderate discomfort," and "unbearable discomfort" at 0, 5, and 10, respectively.
Daily during menstruation on Day 1 (±1 day) of Cycle 2 (phase 2), Cycle 3 and Cycle 4 (phase 3). Up to 147 days from baseline.
Faecal microbial composition
大体时间：Menstruation on Day 1 (±1 day) of Cycle 2 (phase 2) and Cycle 4 (phase 3). Approximately 28-140 days from baseline depending on individual menstrual cycle duration.
Between-group difference (HPLB vs placebo) in faecal microbial composition at phylum, genus, and species level measured using metagenomic sequencing.
Menstruation on Day 1 (±1 day) of Cycle 2 (phase 2) and Cycle 4 (phase 3). Approximately 28-140 days from baseline depending on individual menstrual cycle duration.
Faecal Microbial Diversity
大体时间：Menstruation on Day 1 (±1 day) of Cycle 2 (phase 2) and Cycle 4 (phase 3). Approximately 28-140 days from baseline depending on individual menstrual cycle duration.
Between-group difference (HPLB vs placebo) in faecal microbial diversity at species level measured using metagenomic sequencing.
Menstruation on Day 1 (±1 day) of Cycle 2 (phase 2) and Cycle 4 (phase 3). Approximately 28-140 days from baseline depending on individual menstrual cycle duration.
Faecal Microbial Metabolites
大体时间：Menstruation on Day 1 (±1 day) of Cycle 2 (phase 2) and Cycle 4 (phase 3). Approximately 28-140 days from baseline depending on individual menstrual cycle duration.
Between-group difference (HPLB vs placebo) in faecal microbial metabolites, including short-chain fatty acids.
Menstruation on Day 1 (±1 day) of Cycle 2 (phase 2) and Cycle 4 (phase 3). Approximately 28-140 days from baseline depending on individual menstrual cycle duration.
Adherence to Planned Training
大体时间：Weekly from the start of the first intervention cycle (Cycle 2) through completion of the final intervention cycle (Cycle 4), up to 147 days from baseline.
Between-group difference (HPLB vs placebo) in adherence to physical activity training schedules, measured as the percentage of planned training sessions completed across the two intervention menstrual cycles.
Weekly from the start of the first intervention cycle (Cycle 2) through completion of the final intervention cycle (Cycle 4), up to 147 days from baseline.
Weekly Duration of Physical Training
大体时间：Weekly from the start of the first intervention cycle (Cycle 2) through completion of the final intervention cycle (Cycle 4), up to 147 days from baseline.
Between-group difference (HPLB vs placebo) in average weekly minutes of physical training completed across the two intervention menstrual cycles.
Weekly from the start of the first intervention cycle (Cycle 2) through completion of the final intervention cycle (Cycle 4), up to 147 days from baseline.
Weeks With Moderately Severe or Worse Gastrointestinal Symptoms
大体时间：Weekly across the two intervention menstrual cycles
Between-group difference (HPLB vs placebo) in the number of weeks with moderately severe or worse gastrointestinal symptoms, defined as a GSRS score of 4 or higher in any of the five symptom categories: reflux, abdominal pain, indigestion, diarrhoea, or constipation.
Weekly across the two intervention menstrual cycles
Gastrointestinal-Symptom-Free Weeks
大体时间：Weekly cross the two intervention menstrual cycles
Between-group difference (HPLB vs placebo) in the number of gastrointestinal-symptom-free weeks, defined as a GSRS score of 1 in all five symptom categories: reflux, abdominal pain, indigestion, diarrhoea, and constipation.
Weekly cross the two intervention menstrual cycles

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Liverpool John Moores University

调查人员

  • 首席研究员：Kelsie Johnson, PhD、Liverpool John Moores University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年5月5日

初级完成 (估计的)

2027年3月30日

研究完成 (估计的)

2027年5月30日

研究注册日期

首次提交

2026年4月22日

首先提交符合 QC 标准的

2026年5月5日

首次发布 (实际的)

2026年5月12日

研究记录更新

最后更新发布 (实际的)

2026年6月2日

上次提交的符合 QC 标准的更新

2026年5月29日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

其他研究编号

  • 25/SPS/057_2026

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

De-identified individual participant data that underlie the results reported in this study will be made available upon reasonable request to the principal investigator following publication.

IPD 共享时间框架

Data will be available following publication for a period of up to 5 years.

IPD 共享访问标准

Data will be available to researchers who provide a methodologically sound proposal, subject to approval by the principal investigator. Requests should be directed to the principal investigator.

IPD 共享支持信息类型

  • 研究方案
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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