The Effects of Postbiotic Supplementation in Female Athletes (GIJane)
29 мая 2026 г. обновлено: 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.
Обзор исследования
Статус
Рекрутинг
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Интервенционный
Регистрация (Оцененный)
100
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Kelsie Johnson, PhD
- Номер телефона: +44 0151 231 2121
- Электронная почта: k.o.johnson@ljmu.ac.uk
Учебное резервное копирование контактов
- Имя: Samantha Moss, PhD
- Номер телефона: 0151 231 2121
- Электронная почта: S.L.Moss@ljmu.ac.uk
Места учебы
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Merseyside
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Liverpool, Merseyside, Соединенное Королевство, L3 3AF
- Рекрутинг
- Tom Reilley Building
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Контакт:
- Elizabeth Mahon, PhD
- Электронная почта: e.mahon@ljmu.ac.uk
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Контакт:
- Samanvita Ravikanti, PhDc
- Электронная почта: s.ravikanti@2021.ljmu.ac.uk
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Младший исследователь:
- Samanvita Ravikanti, PhDc
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Младший исследователь:
- Maxine Gaivizo, BSc
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Да
Описание
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Тройной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: 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.
|
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.
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.
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Плацебо Компаратор: 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.
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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.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Gastrointestinal Symptom Severity During Menstruation
Временное ограничение: 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.
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At the post menstruation assessment following completion of cycle 4 ~84-147 days depending on individual cycle and menstruation duration
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Total Gastrointestinal Symptom Rating Scale (GSRS) score assessed weekly across the two intervention menstrual cycles.
Временное ограничение: 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".
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Weekly from the start of Cycle 2 through completion of Cycle 4 (up to 147 days from baseline; cycles range 21-35 days
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Total Gastrointestinal Symptom Rating Scale Score
Временное ограничение: 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
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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".
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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
|
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GSRS Sub-Category Scores
Временное ограничение: 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
|
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Wilson Gastrointestinal Symptom Score
Временное ограничение: 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.
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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.
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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.
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Faecal microbial composition
Временное ограничение: 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.
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Between-group difference (HPLB vs placebo) in faecal microbial composition at phylum, genus, and species level measured using metagenomic sequencing.
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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.
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Faecal Microbial Diversity
Временное ограничение: 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.
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Between-group difference (HPLB vs placebo) in faecal microbial diversity at species level measured using metagenomic sequencing.
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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.
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Faecal Microbial Metabolites
Временное ограничение: 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.
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Between-group difference (HPLB vs placebo) in faecal microbial metabolites, including short-chain fatty acids.
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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.
|
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Adherence to Planned Training
Временное ограничение: 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.
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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.
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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.
|
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Weekly Duration of Physical Training
Временное ограничение: 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.
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Between-group difference (HPLB vs placebo) in average weekly minutes of physical training completed across the two intervention menstrual cycles.
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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.
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Weeks With Moderately Severe or Worse Gastrointestinal Symptoms
Временное ограничение: 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.
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Weekly across the two intervention menstrual cycles
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Gastrointestinal-Symptom-Free Weeks
Временное ограничение: Weekly cross the two intervention menstrual cycles
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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
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Следователи
- Главный следователь: Kelsie Johnson, PhD, Liverpool John Moores University
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Общие публикации
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- Salminen S, Collado MC, Endo A, Hill C, Lebeer S, Quigley EMM, Sanders ME, Shamir R, Swann JR, Szajewska H, Vinderola G. The International Scientific Association of Probiotics and Prebiotics (ISAPP) consensus statement on the definition and scope of postbiotics. Nat Rev Gastroenterol Hepatol. 2021 Sep;18(9):649-667. doi: 10.1038/s41575-021-00440-6. Epub 2021 May 4.
- Hariri Z, Yari Z, Hoseini S, Abhari K, Sohrab G. Synbiotic as an ameliorating factor in the health-related quality of life in women with polycystic ovary syndrome. A randomized, triple-blind, placebo-controlled trial. BMC Womens Health. 2024 Jan 3;24(1):19. doi: 10.1186/s12905-023-02868-1.
- Pugh JN, Lydon KM, O'Donovan CM, O'Sullivan O, Madigan SM. More than a gut feeling: What is the role of the gastrointestinal tract in female athlete health? Eur J Sport Sci. 2022 May;22(5):755-764. doi: 10.1080/17461391.2021.1921853. Epub 2021 May 20.
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Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
5 мая 2026 г.
Первичное завершение (Оцененный)
30 марта 2027 г.
Завершение исследования (Оцененный)
30 мая 2027 г.
Даты регистрации исследования
Первый отправленный
22 апреля 2026 г.
Впервые представлено, что соответствует критериям контроля качества
5 мая 2026 г.
Первый опубликованный (Действительный)
12 мая 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
2 июня 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
29 мая 2026 г.
Последняя проверка
1 мая 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Другие идентификационные номера исследования
- 25/SPS/057_2026
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
ДА
Описание плана IPD
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.
Сроки обмена IPD
Data will be available following publication for a period of up to 5 years.
Критерии совместного доступа к IPD
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.
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- КСО
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .