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| Name | Class |
|---|---|
| dsm-firmenich Switzerland AG | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Active Comparator |
| |
| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Postbiotic | Drug | Participants allocated to this arm will receive the investigational product (Humiome(R) Post LB), to be ingested daily for three consecutive menstrual cycles. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liverpool John Moores University | Liverpool | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30982100 | Background | 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. | |
| 33944684 | Background | 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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| Placebo | Drug | Participants allocated to this arm will receive a visually identical placebo to the verum, to be ingested daily for three consecutive menstrual cycles. |
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| 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. | 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. | 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. | 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. | 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. |
| 32600463 | Background | Judkins 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. |
| 29460487 | Background | Hungin 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. |
| 33199360 | Background | Bruinvels 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. |
| 32881097 | Background | Brown 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. |