Healthy Adult FemalesPhase 1/2GI-JaneNCT07366931
The Effect of Daily Supplementation With Humiome® Post LB on Gastrointestinal Symptoms in Female Athletes
A Phase 1/2 study testing Postbiotic in people with Healthy Adult Females and Gastrointestinal Symptoms, run by Liverpool John Moores University at 1 site in United Kingdom.
Trial summary
Female athletes are often overlooked in scientific research, including the understanding of their digestive system and its impact on overall health, training, and performance. The gastrointestinal (GI) system plays a critical role in supporting digestion, nutrient absorption, and acting as a protective barrier for the… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Females, Gastrointestinal Symptoms
- What is being tested?
- Postbiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jan 2026to 30 Sep 2026
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- Willingness and ability to give informed consent and to understand, to participate, and to comply with the clinical study requirements.
- 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)
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- Having a smartphone and a history of consistent tracking of training and health records via apps.
- Having regular GI issues during exercise, preferably also 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 application, certificates of attendance to 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 health services.
Who cannot join
- 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 illness.
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- Individuals with a current musculoskeletal injury or one within the last month.
- Individuals taking probiotic supplements or who 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 any hypersensitivity/allergy to any of the components of the test product.
- Individuals who have planned major elective surgery during the study period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Liverpool John Moores University
Liverpool
Kat Silang, k.g.silang@ljmu.ac.uk
About this study
Official title: A Randomized, Placebo-controlled, Double-blind Trial on the Effect of Daily Supplementation With Humiome® Post LB on Gastrointestinal Symptoms in Female Athletes
Female athletes are often overlooked in scientific research, including the understanding of their digestive system and its impact on overall health, training, and performance. The gastrointestinal (GI) system plays a critical role in supporting digestion, nutrient absorption, and acting as a protective barrier for the body. While there is some knowledge about the differences in GI structure and function between males and females at rest, there is a lack of understanding regarding how these differences manifest during exercise, especially among female athletes and at different phases of the menstrual cycle.
It has been observed that female athletes commonly report a higher prevalence of GI symptoms compared to males, with many experiencing an increase during menstruation. These symptoms, including bloating, abdominal discomfort, and irregular bowel movements, can significantly disrupt an athlete's training and performance. Elite female athletes have acknowledged that GI symptoms associated with the menstrual cycle have led to altered or disrupted training routines. While these symptoms are commonly recognized to affect a large portion of the female population, few interventions have been studied to assist in managing this discomfort. Some clinicians may direct their patients to take pain-relieving medications without any thoughts on the consequences of chronic use.
Read more
One potential strategy to reduce GI symptoms during endurance exercise is probiotic-postbiotic supplementation. Various probiotic supplements have been shown to effectively decrease diarrhoea, constipation stress, and intestinal permeability, as well as impact immunologic outcomes. Postbiotics differ from probiotics in that they are made from microorganisms that are not alive. They allow the modulation of the composition and function of the gut microbiota and enhance the intestinal barrier to prevent unwanted substances from entering the body proper. While these biotics can relieve lower GI symptoms in irritable bowel syndrome (IBS), there is less consensus regarding their efficacy in modulating exercise-associated GI symptoms. Previous research by Pugh et al., 2019 has demonstrated that four weeks of probiotic supplementation was able to reduce GI symptoms during a marathon race, however this work was predominantly conducted in males and did not take menstrual cycle in consideration. This is important given that symptoms are commonly higher in the early follicular phase when a female experiences their period. Therefore, the aim of this study is to assess the effects of postbiotic supplementation on GI symptomology in female athletes.
The aim of this present study is to investigate the influence of postbiotic supplementation on menstrual cycle symptoms and exercise-associated GI symptoms in female endurance athletes while exercising compared to symptoms while taking a placebo.
- Conditions
- Healthy Adult Females, Gastrointestinal Symptoms
- Being tested
- Postbiotic, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PostbioticDrug
Participants allocated to this arm will receive the investigational product (Humiome(R) Post LB), to be ingested daily for three consecutive menstrual cycles.
PlaceboDrug
Participants allocated to this arm will receive a visually identical placebo to the verum, to be ingested daily for three consecutive menstrual cycles.
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | Not described Receives: Drug: Postbiotic |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal Symptom Rating Scale (GSRS) scores
A list of fifteen gastrointestinal symptoms scored on a Likert scale, where 1=no discomfort at all, and 7=very severe discomfort.
Measured: Starting from Day 1 of the participants' menstrual cycle, the questionnaire is to be completed every seven days for the duration of the trial, an average of three months.
Secondary outcomes (5)
Gastrointestinal Symptom Rating Scale (GSRS) Sub-scores
A list of fifteen gastrointestinal symptoms scored on a Likert scale, where 1=no discomfort at all, and 7=very severe discomfort. The symptoms are grouped into five sub-categories: Reflux, Abdominal pain, Indigestion, Diarrhoea, and Constipation.
Measured: Starting from Day 1 of the participants' menstrual cycle, the questionnaire is to be completed every seven days for the duration of the trial, an average of three months.
Wilson Gastrointestinal (GI) Score
A list of six gastrointestinal symptoms scored on a Likert scale, with the following descriptors:
0=no discomfort 5=moderate discomfort 10=unbearable discomfort.
Measured: Questionnaire to be completed once a day on the days the participants are menstruating. An average of 5 days every cycle, for the duration of the trial, an average of three months.
Faecal microbiome composition
Faecal samples will be collected to assess gut microbial composition using full shotgun sequencing.
Measured: Two times throughout participation (average of three months); first sample is taken after the first month of participation, and second sample taken after the third month of participation. Exact times vary from participant to participant.
Faecal microbiome diversity
Faecal samples will be collected to assess gut microbial diversity using full shotgun sequencing.
Measured: Two times throughout participation (average of three months); first sample is taken after the first month of participation, and second sample taken after the third month of participation. Exact times vary from participant to participant.
Adherence to physical activity training schedules
Participants will be asked to complete a weekly training diary where they will provide any planned training activities and their adherence to these plans. Data taken will be minutes of activity per week and intensity of the training.
Measured: Starting from Day 1 of the participants' menstrual cycle, the diary is to be completed every seven days for the duration of the trial, an average of three months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Healthy Adult FemalesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liverpool John Moores University
- Sponsor type
- University, hospital or other
- Collaborators
- dsm-firmenich Switzerland AG
- Responsible party
- Principal investigator, Kat Silang, Liverpool John Moores University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07366931
- Sponsor's protocol ID
- 25/SPS/057
- Acronym
- GI-Jane
- Status last verified
- Jan 2026
- First submitted
- 17 Dec 2025
- Last updated
- 27 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pugh JN, Sparks AS, Doran DA, Fleming SC, Langan-Evans C, Kirk B, Fearn R, Morton JP, Close GL. Four weeks of probiotic supplementation reduces GI symptoms during a marathon race. Eur J Appl Physiol. 2019 Jul;119(7):1491-1501. doi: 10.1007/s00421-019-04136-3. Epub 2019 Apr 13.
PubMed 30982100Pugh 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.
PubMed 33944684Judkins TC, Dennis-Wall JC, Sims SM, Colee J, Langkamp-Henken B. Stool frequency and form and gastrointestinal symptoms differ by day of the menstrual cycle in healthy adult women taking oral contraceptives: a prospective observational study. BMC Womens Health. 2020 Jun 29;20(1):136. doi: 10.1186/s12905-020-01000-x.
PubMed 32600463Hungin APS, Mitchell CR, Whorwell P, Mulligan C, Cole O, Agreus L, Fracasso P, Lionis C, Mendive J, Philippart de Foy JM, Seifert B, Wensaas KA, Winchester C, de Wit N; European Society for Primary Care Gastroenterology. Systematic review: probiotics in the management of lower gastrointestinal symptoms - an updated evidence-based international consensus. Aliment Pharmacol Ther. 2018 Apr;47(8):1054-1070. doi: 10.1111/apt.14539. Epub 2018 Feb 20.
PubMed 29460487Bruinvels G, Goldsmith E, Blagrove R, Simpkin A, Lewis N, Morton K, Suppiah A, Rogers JP, Ackerman KE, Newell J, Pedlar C. Prevalence and frequency of menstrual cycle symptoms are associated with availability to train and compete: a study of 6812 exercising women recruited using the Strava exercise app. Br J Sports Med. 2021 Apr;55(8):438-443. doi: 10.1136/bjsports-2020-102792. Epub 2020 Nov 16.
PubMed 33199360Brown N, Knight CJ, Forrest Nee Whyte LJ. Elite female athletes' experiences and perceptions of the menstrual cycle on training and sport performance. Scand J Med Sci Sports. 2021 Jan;31(1):52-69. doi: 10.1111/sms.13818. Epub 2020 Sep 19.
PubMed 32881097