The Effects of Postbiotic Supplementation in Female Athletes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorLiverpool John Moores University
About this 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Postbiotic
Dietary supplementPostbiotic 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
Dietary supplementPlacebo 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Postbiotic SupplementationExperimental treatment 2 interventions
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Gastrointestinal Symptom Severity During Menstruation
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.
Time frame
At the post menstruation assessment following completion of cycle 4 ~84-147 days depending on individual cycle and menstruation durationSecondary outcomes
1
Total Gastrointestinal Symptom Rating Scale (GSRS) score assessed weekly across the two intervention menstrual cycles.
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".
Time frame
Weekly from the start of Cycle 2 through completion of Cycle 4 (up to 147 days from baseline; cycles range 21-35 days2
Total Gastrointestinal Symptom Rating Scale Score
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".
Time frame
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 baseline3
GSRS Sub-Category Scores
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".
Time frame
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 baseline4
Wilson Gastrointestinal Symptom Score
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.
Time frame
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov