The Effects of Postbiotic Supplementation in Female Athletes (GIJane)
29 de maio de 2026 atualizado 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.
Visão geral do estudo
Status
Recrutamento
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Intervencional
Inscrição (Estimado)
100
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Kelsie Johnson, PhD
- Número de telefone: +44 0151 231 2121
- E-mail: k.o.johnson@ljmu.ac.uk
Estude backup de contato
- Nome: Samantha Moss, PhD
- Número de telefone: 0151 231 2121
- E-mail: S.L.Moss@ljmu.ac.uk
Locais de estudo
-
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Merseyside
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Liverpool, Merseyside, Reino Unido, L3 3AF
- Recrutamento
- Tom Reilley Building
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Contato:
- Elizabeth Mahon, PhD
- E-mail: e.mahon@ljmu.ac.uk
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Contato:
- Samanvita Ravikanti, PhDc
- E-mail: s.ravikanti@2021.ljmu.ac.uk
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Subinvestigador:
- Samanvita Ravikanti, PhDc
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Subinvestigador:
- Maxine Gaivizo, BSc
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Sim
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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 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.
|
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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Gastrointestinal Symptom Severity During Menstruation
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Total Gastrointestinal Symptom Rating Scale (GSRS) score assessed weekly across the two intervention menstrual cycles.
Prazo: 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
Prazo: 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
|
|
GSRS Sub-Category Scores
Prazo: 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
|
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Wilson Gastrointestinal Symptom Score
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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.
|
Weekly cross the two intervention menstrual cycles
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Kelsie Johnson, PhD, Liverpool John Moores University
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
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- 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.
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Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
5 de maio de 2026
Conclusão Primária (Estimado)
30 de março de 2027
Conclusão do estudo (Estimado)
30 de maio de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
22 de abril de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
5 de maio de 2026
Primeira postagem (Real)
12 de maio de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
2 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
29 de maio de 2026
Última verificação
1 de maio de 2026
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- 25/SPS/057_2026
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano 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.
Prazo de Compartilhamento de IPD
Data will be available following publication for a period of up to 5 years.
Critérios de acesso de compartilhamento 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 informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- CSR
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .