The Effect of Daily Supplementation With Humiome® Post LB on Gastrointestinal Symptoms in Female Athletes. A Double-blinded Randomised Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female, cisgender, premenopausal.
- •Minimum age 18 years.
- •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
- •Ability to give informed consent.
- •Body mass index (BMI) ≥ 18.5 and < 24.9 kg/m²
- •Agreeing to maintain lifestyle habits during the study (same dietary and physical activity habits)
- •Having a smartphone and a history of consistent tracking of training and health records via apps.
- •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).
- •No relevant self-reported abnormalities from medical history.
- •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.).
- •Access to a health-care provider, who can be contacted by the CRO, and who reside in areas with available emergency health services.
排除标准
- •Individuals who are pregnant, lactating, or plan to become pregnant before study end.
- •Individuals with secondary amenorrhea.
- •Individuals who use hormonal contraceptives during the last 6 months before (and during) the trial.
- •Individuals who are currently participating in another clinical trial or have participated in a trial within the last two months prior to enrolment.
- •Tobacco smokers and vapers.
- •Individuals with acute illnesses.
- •Individuals with a current musculoskeletal injury or one within the last month.
- •Individuals taking probiotic supplements or have taken probiotics two weeks prior to enrolment.
- •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.
- •Individuals having received antibiotics treatments within three months of trial start.
- •Individuals having planned major changes in lifestyle (i.e. diet, weight loss program, exercise level, travelling) during the duration of the study.
- •Individuals who have hypersensitivity/allergy to any of the components of the test product.
- •Individuals who have planned major elective surgery during the study period.
研究者
SPSKJOHN@ljmu.AC.UK
Senior Lecturer in Sports Nutrition and Physiology
Liverpool John Moores University