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Radicle GI HealthTM VNB: A Study Assessing the Impact of Health and Wellness Products on Constipation and Related Health Outcomes

18. august 2026 oppdatert av: Radicle Science

Radicle GI HealthTM VNB: A Randomized, Double-Blind, Placebo- Controlled Direct-to-Consumer Study Assessing the Impact of Health and Wellness Products on Constipation and Related Health Outcomes

Radicle GI HealthTM VNB: A randomized, double-blind, placebo- controlled direct-to-consumer study assessing the impact of health and wellness products on constipation and related health outcomes

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This is a randomized, double-blind, placebo-controlled study conducted with adult participants, residing in the United States. Eligible participants will (1) have the opportunity for meaningful improvement (at least 30%) in their primary health outcome, and (2) express acceptance in taking a product and not knowing its formulation until the end of the study.

Participants that report a known contraindication or with well-established, significant safety concerns due to illness will be excluded. Heavy drinkers and those who report they are pregnant, trying to become pregnant, or breastfeeding will be excluded. Participants that report taking medications with a known contraindication or with well-established, significant safety concerns will be excluded. Self-reported data are collected electronically from eligible participants for 5 weeks. Participant reports of health indicators will be collected at enrollment and throughout the active period of study product usage. All study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study.

Studietype

Intervensjonell

Registrering (Antatt)

550

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Beskrivelse

3.1 Inclusion

Participants must meet all the following criteria:

  • Adults, at least 21 years of age at the time of electronic consent, inclusive of all ethnicities, races, and gender identities

    • Assigned sex at birth will determine sex-specific recruitment and PROs (male vs female) employed, when needed
  • Resides in the United States
  • Has the opportunity for at least 30% improvement in their primary health outcome
  • Expresses a willingness to take a study product and not know the product identity (active or placebo) until the end of the study

3.2 Exclusion

Individuals who report any of the following during screening may be excluded from participation:

  • Report being pregnant, trying to become pregnant, or breastfeeding
  • Unable to provide a valid US shipping address and mobile phone number
  • Reports current enrollment in another clinical trial
  • Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day)
  • Unable to read and understand English at a 7th grade level
  • Reports a current and/or recent (up to 3 months ago) major illness and/or surgery that poses a known, significant safety risk.

  • Reports a diagnosis of cardiac dysfunction, liver or kidney disease that presents a known contraindication and/or a significant safety risk with any of the study product ingredients.

    • NYHA Class III or IV congestive heart failure, atrial fibrillation, uncontrolled arrhythmias, cirrhosis, end-stage liver disease, stage 3b or 4 chronic kidney disease, or kidney failure

  • Reports taking medications that have a well-established moderate or severe interaction, posing a substantial safety risk with any of the study product ingredients.

    • Anticoagulants, antihypertensives, anxiolytics, antidepressants, chemotherapy, immunotherapy, sedative hypnotics, seizure medications, medications that warn against grapefruit consumption, corticosteroids at doses greater than 5 mg per day, diabetic medications, oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, MAOIs, or thyroid products

  • Reports current use of the primary ingredient(s) and/or similar product(s) to the active study product(s) that may limit the effects of the study products and/or pose a safety risk

    • Reports taking any product for acute constipation
    • Reports taking any medications containing levodopa
  • Lack of reliable daily access to the internet

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Active GI Health Product 1
Kosttilskudd: Active GI Health Product
Participants will use their Active GI Health Product as directed for a period of 4 weeks
Placebo komparator: Placebo GI Health Control
Kosttilskudd: Placebo GI Health Control
Participants will use their Placebo GI Health Control product as directed for a period of 4 weeks

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Constipation
Tidsramme: 5 weeks
Change in Constipation: Difference between rates of change over time in constipation score as assessed by PROMIS Constipation 9A (scale 5-45; where the higher scores correspond to worse constipation)
5 weeks

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Gas and Bloating
Tidsramme: 5 weeks
Change in Gas and Bloating: Difference between rates of change over time in gas and bloating score as assessed by PROMIS Gas and Bloating 13A (scale 3-59; where the higher scores correspond to worse gas and bloating)
5 weeks
Change in GI-related Quality of Life (QOL)
Tidsramme: 5 weeks
Change in GI-related Quality of Life (QOL): Difference between rates of change over time in GI-related QOL as assessed by Digestion-associated Quality of Life Questionnaire (scale 0-9; where the higher scores correspond to worse GI-related quality of life)
5 weeks
Change in the severity of gastrointestinal symptoms
Tidsramme: 5 weeks
Change in the severity of gastrointestinal symptoms: Difference between rates of change over time in gastrointestinal symptoms score as assessed by GSRS (scale 7-105; with higher scores equaling greater severity)
5 weeks

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Minimal clinically important difference (MCID) in Constipation
Tidsramme: 5 weeks
Minimal clinically important difference (MCID) in Constipation: Likelihood of experiencing minimal clinically important difference in constipation, as measured by PROMIS Constipation 9A (scale 5-45; where the higher scores correspond to worse constipation)
5 weeks
Minimal clinically important difference (MCID) in Gas and Bloating
Tidsramme: 5 weeks
Minimal clinically important difference (MCID) in Gas and Bloating: Likelihood of experiencing minimal clinically important difference in gas and bloating, as measured by PROMIS Gas and Bloating 13A (scale 3-59; where the higher scores correspond to worse gas and bloating)
5 weeks
Minimal clinically important difference (MCID) in GI-related Quality of Life (QOL)
Tidsramme: 5 weeks
Minimal clinically important difference (MCID) in GI-related Quality of Life (QOL): Likelihood of experiencing minimal clinically important difference in GI-related QOL as assessed by Digestion-associated Quality of Life Questionnaire (scale 0-9; where the higher scores correspond to worse GI-related quality of life)
5 weeks
Change in Diarrhea
Tidsramme: 5 weeks
Change in Diarrhea: Difference between rates of change over time in diarrhea score as assessed by PROMIS Diarrhea 6A (scale 2-30; where the higher scores correspond to worse diarrhea)
5 weeks
Minimal clinically important difference (MCID) in Diarrhea
Tidsramme: 5 weeks
Minimal clinically important difference (MCID) in Diarrhea: Likelihood of experiencing minimal clinically important difference in diarrhea, as measured by PROMIS Diarrhea 6A scale (2-30; where the higher scores correspond to worse diarrhea)
5 weeks
Change in cognitive function
Tidsramme: 5 weeks
Change in cognitive function: Difference in rates of change over time in cognitive function score as assessed by PROMIS Cognitive Function 4A (scale 4-20; where lower scores correspond to worse cognitive function)
5 weeks
Minimal clinically important difference (MCID) in cognitive function
Tidsramme: 5 weeks
Minimal clinically important difference (MCID) in cognitive function: Likelihood of experiencing minimal clinically important difference in cognitive function score as assessed by PROMIS Cognitive Function 4A (scale 4-20; where lower scores correspond to worse cognitive function)
5 weeks
Minimal clinically important difference (MCID) in the severity of gastrointestinal symptoms
Tidsramme: 5 weeks
Minimal clinically important difference (MCID) in the severity of gastrointestinal symptoms: Likelihood of experiencing minimal clinically important difference in gastrointestinal symptoms score as assessed by GSRS (scale 7-105; with higher scores equaling greater severity)
5 weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Radicle Science

Etterforskere

  • Hovedetterforsker: Susan Hewlings, Radicle Science

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

30. juli 2026

Primær fullføring (Antatt)

16. juli 2027

Studiet fullført (Antatt)

16. juli 2027

Datoer for studieregistrering

Først innsendt

15. juli 2026

Først innsendt som oppfylte QC-kriteriene

15. juli 2026

Først lagt ut (Faktiske)

20. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

20. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

18. august 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • RADX_P_2604_VNB

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

Data will not be shared with researchers outside of Radicle Collaborators on this study.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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