- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07628608
Safety and User Experience of BP-CBB
A Placebo-controlled, Double-blind, Safety and Experience Evaluation of IgG Binding Protein CBB (BP-CBB)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Emily Goodbody
- Telefonnummer: +353 (0) 86-218-8787
- E-mail: egoodbody@atlantiatrials.com
Undersøgelse Kontakt Backup
- Navn: Emma Harrington
- Telefonnummer: +353 (0) 86-218-8787
- E-mail: eharrington@atlantiatrials.com
Studiesteder
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-
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Cork, Irland, T23 R50R
- Atlantia Clinical Trials
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Kontakt:
- Emily Goodbody
- Telefonnummer: +353 (0) 86-218-8787
- E-mail: egoodbody@atlantiatrials.com
-
Kontakt:
- Emma Harrington
- Telefonnummer: +353 (0) 86-218-8787
- E-mail: eharrington@atlantiatrials.com
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Test arm
Receives Test product containing BP-CBB
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Dietary supplement containing BP-CBB
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Placebo komparator: Placebo arm
Receives Placebo product without BP-CBB
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Receives dietary supplement without BP-CBB
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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To evaluate the safety and tolerability of once daily intake of the novel food ingredient BP-CBB in healthy adults
Tidsramme: 8 weeks
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Incidence of all AEs per arm by product causality.
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8 weeks
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Martin Buckley, Professor, Atlantia Clinical Trials
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- AFCRO-204
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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Kliniske forsøg med BP-CBB
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Mayo ClinicTilmelding efter invitation
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Chinese University of Hong KongAfsluttet
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Cedars-Sinai Medical CenterNational Heart, Lung, and Blood Institute (NHLBI)AfsluttetForhøjet blodtrykForenede Stater
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University of MinnesotaMayo Clinic; University of Pennsylvania; University of Alabama at Birmingham og andre samarbejdspartnereAfsluttetForhøjet blodtrykForenede Stater
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VA Office of Research and DevelopmentRekruttering
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Hospital General Universitario ElcheAfsluttet
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University of California, San FranciscoAmerican Heart Association; American Medical Association; OCHIN, Inc.; Louisiana...AfsluttetForhøjet blodtrykForenede Stater
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MGB Biopharma LimitedHammersmith Medicines Research; Innovate UK; Cambridge Regulatory Services; Phases Clinical Research Limited og andre samarbejdspartnereAfsluttetSund og rask
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Vanderbilt University Medical CenterAfsluttetBlodtryk | Sygelig fedme | Præeklampsi | FødendeForenede Stater
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University of Missouri-ColumbiaTilmelding efter invitationMetabolisk syndrom | Fedme, sygelig | NASH - Ikke-alkoholisk SteatohepatitisForenede Stater