Investigação Probiótica: Intervenção Funcional Aberta e Avaliação Longitudinal em Adultos Saudáveis (PROFILE)
This study is a pre-post, open-label cohort study designed to investigate how a food-grade probiotic supplement affects biological measurements and wellbeing in healthy adults. Participants will take one capsule daily for either 1 month or 6 months.
During the study, participants will complete online cognitive tasks and provide blood and stool samples collected during home visits by trained staff. The samples will be analysed to explore changes in gut bacteria and other biological markers.
This study aims to understand whether the supplement is well tolerated and whether measurable biological changes occur. The study does not involve any experimental drugs or invasive procedures beyond blood sampling and stool collection, and participants will not be asked to change any current prescribed medications or treatments; with eligibility exclusions applying for recent antibiotics or immunosuppressants. The supplement is being studied for research purposes only and is not intended to diagnose, treat, or prevent disease. Participants will be invited to participate in a follow-up visit to assess long-term effects.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Research Team
- Número de telefone: +44 7757 056785
- E-mail: team@healthspanbiotics.com
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Aged 18 years or older at the time of providing informed consent.
- In generally good health, with no known medical conditions that could interfere with the aims of the study or participant safety, as judged by self-report and screening questionnaire.
- No history of significant psychiatric or neurological illness
- Ability to complete study specific tasks, including:
- Daily oral intake of a probiotic capsule
- Self-collection of stool samples
- Completion of online questionnaires and simple cognitive tasks
- Able to read, understand, and communicate in English, in order to give informed consent and follow study instructions.
- Access to the internet and a suitable device (e.g., smartphone, tablet, or computer) for completing online aspects of the study.
Exclusion Criteria:
- Participants will be excluded from the study if any of the following criteria apply:
- Use of any systemic antibiotic or systemic immunosuppressive medication within the past 8 weeks, including but not limited to:
- β-lactam antibiotics, macrolides, tetracyclines, fluoroquinolones, aminoglycosides, glycopeptides, sulfonamides, antimycobacterial agents, systemic antifungals or antivirals
- Use of any systemic immunosuppressants within the past 16 weeks, including, but not limited to:
- Systemic corticosteroids, conventional immunosuppressants, biologic immunomodulators, targeted synthetic immunosuppressants, cytotoxic chemotherapy, or transplant-related immunosuppression.
- A longer exclusion window is applied for systemic immunosuppressive therapies due to their prolonged and potentially lasting effects on immune function and gut microbial composition compared with systemic antibiotics.
- Participants who commence systemic antibiotics or immunosuppressive therapy after enrolment will not be withdrawn from safety monitoring but will stop the supplement and will not continue the intervention phase of the study. With participant consent, data collected may still be used.
- Major gastrointestinal disease or surgery:
- Any history of significant gastrointestinal disease or surgery that may alter gut microbiome composition, immune function, or nutrient absorption, including but not limited to inflammatory bowel disease (Crohn's disease, ulcerative colitis, indeterminate colitis); coeliac disease or other chronic malabsorptive disorders; chronic liver, biliary, or pancreatic disease; moderate-to-severe or unstable irritable bowel syndrome; gastrointestinal malignancy; chronic gastrointestinal motility disorders; recurrent Clostridioides difficile infection; or any major gastrointestinal surgery such as bowel resection, bariatric surgery, colectomy, ileostomy or colostomy. Prior appendectomy or cholecystectomy alone is not exclusionary.
- Current pregnancy or development of pregnancy, breastfeeding
- Known allergy to probiotic or compounding ingredients:
- Vitamin D3
- Isomaltooligosaccharide
- Yeast extract
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Ciência básica
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Short Phase Group
This group will receive supplementation for 1 month |
This probiotic is a proprietary food-grade supplement that is not yet commercially available or CE-marked. |
|
Experimental: Long Phase Group
This group will receive supplementation for 6 months |
This probiotic is a proprietary food-grade supplement that is not yet commercially available or CE-marked. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Changes in metagenome of stool samples
Prazo: From enrolment to the end of treatment at 4 or 24 weeks respectively. Optionally, a follow-up measure may be offered 24 weeks after the end of treatment.
|
The investigators will evaluate changes in genetic material in participant stool, representing establishment of the probiotic in the digestive tract |
From enrolment to the end of treatment at 4 or 24 weeks respectively. Optionally, a follow-up measure may be offered 24 weeks after the end of treatment.
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in blood multiome
Prazo: From enrolment to the end of treatment at 4 or 24 weeks respectively. Optionally, a follow-up measure may be offered 24 weeks after the end of treatment.
|
This measure will evaluate change in blood proteins (plasma proteome) and blood metabolites (plasma metabolome). Both measures are quantified using mass to charge ratio. |
From enrolment to the end of treatment at 4 or 24 weeks respectively. Optionally, a follow-up measure may be offered 24 weeks after the end of treatment.
|
|
Changes in cognition
Prazo: Assessed weekly from enrolment and to end of treatment at 4 or 24 weeks respectively.
|
Participants will complete a weekly online cognitive test administered via our remote platform. This generates a score relativised to each participant's performance, and does not utilise a scale. |
Assessed weekly from enrolment and to end of treatment at 4 or 24 weeks respectively.
|
|
Change in daytime sleepiness
Prazo: Assessed at enrolment and at end of treatment at 4 or 24 weeks respectively.
|
Participants will complete the Epworth Sleepiness Scale (ESS), with a minimum score of 0, and a maximum score of 24. A higher score indicates worse daytime sleepiness. |
Assessed at enrolment and at end of treatment at 4 or 24 weeks respectively.
|
|
Change in sleep quality
Prazo: Assessed at enrolment and at end of treatment at 4 or 24 weeks respectively.
|
Participants will complete the Pittsburgh Sleep Quality Index (PSQI) survey. This has a minimum global score of 0, and a maximum of 21. A higher score indicates worse sleep quality. |
Assessed at enrolment and at end of treatment at 4 or 24 weeks respectively.
|
|
Change in self-reported wellbeing and mood
Prazo: Assessed at enrolment and at end of treatment at 4 or 24 weeks respectively.
|
Participants will fill out a questionnaire at the beginning and end of the study which will ask questions about subjective mood and wellbeing. |
Assessed at enrolment and at end of treatment at 4 or 24 weeks respectively.
|
|
Adverse event monitoring
Prazo: Assessed from enrolment until end of treatment at 4 or 24 weeks respectively.
|
Participants will be expected to self-report any adverse features resulting from use of the supplement |
Assessed from enrolment until end of treatment at 4 or 24 weeks respectively.
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- PROFILE
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
All personal data collected during the study will be pseudonymised at the earliest possible stage. Each participant will be assigned a unique study ID number, which will be used on all samples, questionnaires, and datasets. A separate, password-protected file will securely store the link between participant names and study IDs. This file will be accessible only to authorised study personnel.
No identifiable personal information will be included in the research database or shared with external analysts. All electronic data will be stored on secure, encrypted servers in compliance with UK GDPR and the Data Protection Act 2018. Access will be limited to members of the research team through password-protected accounts and role-based permissions.
Hard copies of personal data will not be collected or stored. Any correspondence containing identifiable information (e.g. email addresses) will be deleted or anonymised once no longer needed.
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