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The Effects of Postbiotic Supplementation in Female Athletes (GIJane)

29 maja 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

100

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Tak

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Potroić

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Suplement diety: 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.
Suplement diety: 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.
Komparator placebo: 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.
Suplement diety: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Gastrointestinal Symptom Severity During Menstruation
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Total Gastrointestinal Symptom Rating Scale (GSRS) score assessed weekly across the two intervention menstrual cycles.
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Liverpool John Moores University

Śledczy

  • Główny śledczy: Kelsie Johnson, PhD, Liverpool John Moores University

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

5 maja 2026

Zakończenie podstawowe (Szacowany)

30 marca 2027

Ukończenie studiów (Szacowany)

30 maja 2027

Daty rejestracji na studia

Pierwszy przesłany

22 kwietnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

5 maja 2026

Pierwszy wysłany (Rzeczywisty)

12 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

2 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

29 maja 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • 25/SPS/057_2026

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu 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.

Ramy czasowe udostępniania IPD

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

Kryteria dostępu do udostępniania 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.

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • CSR

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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