- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07628608
Safety and User Experience of BP-CBB
A Placebo-controlled, Double-blind, Safety and Experience Evaluation of IgG Binding Protein CBB (BP-CBB)
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Emily Goodbody
- Numero di telefono: +353 (0) 86-218-8787
- Email: egoodbody@atlantiatrials.com
Backup dei contatti dello studio
- Nome: Emma Harrington
- Numero di telefono: +353 (0) 86-218-8787
- Email: eharrington@atlantiatrials.com
Luoghi di studio
-
-
-
Cork, Irlanda, T23 R50R
- Atlantia Clinical Trials
-
Contatto:
- Emily Goodbody
- Numero di telefono: +353 (0) 86-218-8787
- Email: egoodbody@atlantiatrials.com
-
Contatto:
- Emma Harrington
- Numero di telefono: +353 (0) 86-218-8787
- Email: eharrington@atlantiatrials.com
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
Inclusion Criteria:
- Be able to give written informed consent.
- Be between 18-65 years, both inclusive.
- Record greater than 3 bowel movements recorded during the one-week run-in period.
- In general, in good health, as determined by the investigator.
- Willing to consume the Study Product once daily for the duration of the study.
- Willing to avoid pro, pre post biotics and any new supplements for the duration of the study
Exclusion Criteria:
- Participants who are pregnant or wish to become pregnant during the study or who are lactating and/or currently breastfeeding.
Participants currently of biological childbearing potential, but not using a continuous effective method of contraception, as outlined below:
- Complete abstinence from intercourse two weeks prior to administration of the Study Product, throughout the clinical study, until the completion of follow-up procedures or for two weeks following discontinuation of the Study Product in cases where Participant discontinues the study prematurely. (Participants utilising this method must agree to use an alternate method of contraception if they should become sexually active and will be queried on whether they have been abstinent in the preceding two weeks when they present to the clinic for the final visit).
- Has a male sexual partner who is surgically sterilised prior to the Screening Visit and is the only male sexual partner for that Participant.
- Sexual partner(s) is/are exclusively female.
- Use of acceptable method of contraception, such as a spermicide, mechanical barrier (e.g., male condom, female diaphragm), tubal ligation, or contraceptive pill. The Participant must be using this method for at least one week prior to and one week following the end of the study.
- Use of any intrauterine device (IUD) or contraceptive implant. The Participant must have the device inserted at least two weeks prior to the first screening visit, throughout the study, and two weeks following the end of the study.
- Has a history of drug and/or alcohol abuse.
- Has known food allergies, history of Type I (IgE-mediated) food allergies, or hypersensitivity or other issues with foods or ingredients that would preclude intake of the Study Product (i.e. soya).
Has any significant acute or chronic coexisting health conditions that would prevent them from fulfilling the study requirements, put the Participant at risk or would confound the interpretation of the study results as judged by the investigator on the basis of medical history and routine laboratory test results. Excluded health conditions include:
- Diagnosed gastrointestinal conditions
- Previous bariatric surgery
- Immunocompromised health conditions
Current or recent use of a medication that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results. Prohibited medications include:
- Systemic antibiotics - in the 4 weeks prior to Visit 1
- Proton pump inhibitors (PPIs) - in the past 4 prior to Visit 1
- Non-steroidal anti-inflammatory drugs (NSAIDs) - in the past 2 weeks prior to Visit 1
- GLP-1 agonists - in the 12 weeks prior to Visit 1
- SGLT-2 inhibitors - in the 12 weeks prior to Visit 1
Current or recent (in the 4-weeks prior to Visit 1) use of prohibited nutritional or non-nutritional supplements that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results. Prohibited supplements include:
- Probiotics
- Prebiotics
- Synbiotics
- Postbiotics
- Regular (weekly) consumption of fermented food products (e.g. kefir, kombucha)
- Planning to make significant dietary or lifestyle changes during the study period (e.g., travel, exercise, diet, change in body weight).
- Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the study.
- Participants may not be participating in other clinical studies. If the participant has previously taken part in an experimental study, the Investigator must ensure sufficient time has elapsed before entry to this study to ensure the integrity of the results.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Test arm
Receives Test product containing BP-CBB
|
Dietary supplement containing BP-CBB
|
|
Comparatore placebo: Placebo arm
Receives Placebo product without BP-CBB
|
Receives dietary supplement without BP-CBB
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
To evaluate the safety and tolerability of once daily intake of the novel food ingredient BP-CBB in healthy adults
Lasso di tempo: 8 weeks
|
Incidence of all AEs per arm by product causality.
|
8 weeks
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Martin Buckley, Professor, Atlantia Clinical Trials
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- AFCRO-204
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su BP-CBB
-
Chinese University of Hong KongCompletato
-
Mayo ClinicIscrizione su invito
-
University of MinnesotaMayo Clinic; University of Pennsylvania; University of Alabama at Birmingham; Vanderbilt... e altri collaboratoriCompletato
-
MGB Biopharma LimitedHammersmith Medicines Research; Innovate UK; Cambridge Regulatory Services; Phases... e altri collaboratoriCompletato
-
Hospital General Universitario ElcheCompletato
-
Southcentral FoundationWashington State UniversityCompletatoIpertensioneStati Uniti
-
University of Missouri-ColumbiaIscrizione su invitoSindrome metabolica | Obesità, morboso | NASH - Steatoepatite non alcolicaStati Uniti
-
Biopharma Plasma LLCReclutamentoMalattie da immunodeficienza primariaUcraina
-
NYU Langone HealthNational Institute on Minority Health and Health Disparities (NIMHD)Reclutamento
-
University of California, DavisCompletato