The Effects of Postbiotic Supplementation in Female Athletes (GIJane)
29 de mayo de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
100
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Kelsie Johnson, PhD
- Número de teléfono: +44 0151 231 2121
- Correo electrónico: k.o.johnson@ljmu.ac.uk
Copia de seguridad de contactos de estudio
- Nombre: Samantha Moss, PhD
- Número de teléfono: 0151 231 2121
- Correo electrónico: S.L.Moss@ljmu.ac.uk
Ubicaciones de estudio
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Merseyside
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Liverpool, Merseyside, Reino Unido, L3 3AF
- Reclutamiento
- Tom Reilley Building
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Contacto:
- Elizabeth Mahon, PhD
- Correo electrónico: e.mahon@ljmu.ac.uk
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Contacto:
- Samanvita Ravikanti, PhDc
- Correo electrónico: s.ravikanti@2021.ljmu.ac.uk
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Sub-Investigador:
- Samanvita Ravikanti, PhDc
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Sub-Investigador:
- Maxine Gaivizo, BSc
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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.
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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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Comparador de placebos: 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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Gastrointestinal Symptom Severity During Menstruation
Periodo de tiempo: At the post menstruation assessment following completion of cycle 4 ~84-147 days depending on individual cycle and menstruation duration
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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
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Total Gastrointestinal Symptom Rating Scale (GSRS) score assessed weekly across the two intervention menstrual cycles.
Periodo de tiempo: 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
Periodo de tiempo: 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".
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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
Periodo de tiempo: 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".
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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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Wilson Gastrointestinal Symptom Score
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Weekly across the two intervention menstrual cycles
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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
Periodo de tiempo: 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.
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Weekly cross the two intervention menstrual cycles
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Kelsie Johnson, PhD, Liverpool John Moores University
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Pfeiffer B, Stellingwerff T, Zaltas E, Jeukendrup AE. Oxidation of solid versus liquid CHO sources during exercise. Med Sci Sports Exerc. 2010 Nov;42(11):2030-7. doi: 10.1249/MSS.0b013e3181e0efc9.
- Hempel S, Newberry S, Ruelaz A, Wang Z, Miles JN, Suttorp MJ, Johnsen B, Shanman R, Slusser W, Fu N, Smith A, Roth B, Polak J, Motala A, Perry T, Shekelle PG. Safety of probiotics used to reduce risk and prevent or treat disease. Evid Rep Technol Assess (Full Rep). 2011 Apr;(200):1-645.
- Svedlund J, Sjodin I, Dotevall G. GSRS--a clinical rating scale for gastrointestinal symptoms in patients with irritable bowel syndrome and peptic ulcer disease. Dig Dis Sci. 1988 Feb;33(2):129-34. doi: 10.1007/BF01535722.
- 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.
- Kulich KR, Madisch A, Pacini F, Pique JM, Regula J, Van Rensburg CJ, Ujszaszy L, Carlsson J, Halling K, Wiklund IK. Reliability and validity of the Gastrointestinal Symptom Rating Scale (GSRS) and Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaire in dyspepsia: a six-country study. Health Qual Life Outcomes. 2008 Jan 31;6:12. doi: 10.1186/1477-7525-6-12.
- Ljotsson B, Jones M, Talley NJ, Kjellstrom L, Agreus L, Andreasson A. Discriminant and convergent validity of the GSRS-IBS symptom severity measure for irritable bowel syndrome: A population study. United European Gastroenterol J. 2020 Apr;8(3):284-292. doi: 10.1177/2050640619900577. Epub 2020 Jan 14.
- 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.
- 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.
- 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.
- 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.
- 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.
- Xiao SD, Zhang DZ, Lu H, Jiang SH, Liu HY, Wang GS, Xu GM, Zhang ZB, Lin GJ, Wang GL. Multicenter, randomized, controlled trial of heat-killed Lactobacillus acidophilus LB in patients with chronic diarrhea. Adv Ther. 2003 Sep-Oct;20(5):253-60. doi: 10.1007/BF02849854.
- Wilson PB. Frequency of Chronic Gastrointestinal Distress in Runners: Validity and Reliability of a Retrospective Questionnaire. Int J Sport Nutr Exerc Metab. 2017 Aug;27(4):370-376. doi: 10.1123/ijsnem.2016-0305. Epub 2017 Mar 2.
- Abbott SJ, Parker CJ, Hough J, Hunter KA, Johnson MA, Williams NC. The Effects of Menstrual Cycle Phase on Gastrointestinal Responses to a Simulated Football Match. Eur J Sport Sci. 2026 Apr;26(4):e70157. doi: 10.1002/ejsc.70157.
- Roberts JD, Suckling CA, Peedle GY, Murphy JA, Dawkins TG, Roberts MG. An Exploratory Investigation of Endotoxin Levels in Novice Long Distance Triathletes, and the Effects of a Multi-Strain Probiotic/Prebiotic, Antioxidant Intervention. Nutrients. 2016 Nov 17;8(11):733. doi: 10.3390/nu8110733.
- Liu A, Ma T, Xu N, Jin H, Zhao F, Kwok LY, Zhang H, Zhang S, Sun Z. Adjunctive Probiotics Alleviates Asthmatic Symptoms via Modulating the Gut Microbiome and Serum Metabolome. Microbiol Spectr. 2021 Oct 31;9(2):e0085921. doi: 10.1128/Spectrum.00859-21. Epub 2021 Oct 6.
- Lievin-Le Moal V, Sarrazin-Davila LE, Servin AL. An experimental study and a randomized, double-blind, placebo-controlled clinical trial to evaluate the antisecretory activity of Lactobacillus acidophilus strain LB against nonrotavirus diarrhea. Pediatrics. 2007 Oct;120(4):e795-803. doi: 10.1542/peds.2006-2930. Epub 2007 Sep 3.
- Chahwan B, Kwan S, Isik A, van Hemert S, Burke C, Roberts L. Gut feelings: A randomised, triple-blind, placebo-controlled trial of probiotics for depressive symptoms. J Affect Disord. 2019 Jun 15;253:317-326. doi: 10.1016/j.jad.2019.04.097. Epub 2019 May 9.
- Canducci F, Armuzzi A, Cremonini F, Cammarota G, Bartolozzi F, Pola P, Gasbarrini G, Gasbarrini A. A lyophilized and inactivated culture of Lactobacillus acidophilus increases Helicobacter pylori eradication rates. Aliment Pharmacol Ther. 2000 Dec;14(12):1625-9. doi: 10.1046/j.1365-2036.2000.00885.x.
- Alvarez M, Colee J, Langkamp-Henken B, Dahl WJ. Assessing Gastrointestinal Tolerance in Healthy Adults: Reliability and Validity of a Weekly Questionnaire. Curr Dev Nutr. 2023 Jul 20;7(8):101976. doi: 10.1016/j.cdnut.2023.101976. eCollection 2023 Aug.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
5 de mayo de 2026
Finalización primaria (Estimado)
30 de marzo de 2027
Finalización del estudio (Estimado)
30 de mayo de 2027
Fechas de registro del estudio
Enviado por primera vez
22 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
5 de mayo de 2026
Publicado por primera vez (Actual)
12 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
2 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
29 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 25/SPS/057_2026
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan 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.
Marco de tiempo para compartir IPD
Data will be available following publication for a period of up to 5 years.
Criterios de acceso compartido de 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.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .