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Radicle GI Health™ RFY: A Study Assessing the Impact of DAO Supplementation on Gastrointestinal and Other Histamine Intolerance Symptoms

17 septembre 2026 mis à jour par: Radicle Science

Radicle GI Health™ RFY: A Randomized, Double-Blind, Placebo-Controlled Study Assessing the Impact of DAO Supplementation on Gastrointestinal and Other Histamine Intolerance Symptoms

Radicle GI Health™ RFY: A Randomized, Double-Blind, Placebo-Controlled Study Assessing the Impact of DAO Supplementation on Gastrointestinal and other Histamine Intolerance Symptoms.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

This is a randomized, double-blind, placebo-controlled study conducted with adult participants, residing in the United States.

Eligible participants will (1) have histamine intolerance symptoms affecting GI health and at least one other organ/system, (2) have the opportunity for meaningful improvement (at least 30%) in their primary health outcome, and (3) 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 7 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.

Type d'étude

Interventionnel

Inscription (Estimé)

550

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

21 ans à 105 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

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

  • Report histamine intolerance symptoms affecting GI health and at least one other organ/system, determined from the Histamine Intolerance Checklist

  • 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

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. This may include:

    • 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. This may include:

    • 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

  • Lack of reliable daily access to the internet

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Autre
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Active GI Health Product 1

Active GI Health Product 1
Complément alimentaire: Active GI Health Product 1

Participants will use their Active GI Health Product 1 as directed for a period of 6 weeks
Comparateur placebo: Placebo GI Health Control

Placebo GI Health Control
Complément alimentaire: Placebo GI Health Control

Participants will use their Placebo GI Health Control as directed for a period of 6 weeks

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in the severity of gastrointestinal symptoms
Délai: 7 weeks

Change in the severity of gastrointestinal symptoms: Difference between rates of change over time in gastrointestinal symptoms score as assessed by GSRS (scale 15-105; with higher scores equaling greater severity)
7 weeks

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in GI-related Quality of Life (QOL)
Délai: 7 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)
7 weeks
Change in rhinitis symptom control
Délai: 7 weeks

Change in rhinitis symptom control: Change in control of rhinitis symptoms as assessed by the Rhinitis Control Assessment Test (RCAT) (Scores range from 6 to 30, with higher scores indicating better rhinitis symptom control.)
7 weeks
Change in itch severity
Délai: 7 weeks

Change in the severity of itching: Difference between rates of change over time in itch severity as assessed by the Itch Severity Scale (ISS; scale 0-21; with higher scores equaling greater severity)
7 weeks

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Minimal clinically important difference (MCID) in the severity of gastrointestinal symptoms
Délai: 7 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 15-105; with higher scores equaling greater severity)
7 weeks
Minimal clinically important difference (MCID) in GI-related Quality of Life (QOL)
Délai: 7 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)
7 weeks
Minimal clinically important difference in rhinitis symptom control
Délai: 7 weeks

Minimal clinically important difference in rhinitis symptom control: Likelihood of experiencing minimal clinically important difference in control of rhinitis symptoms as assessed by the Rhinitis Control Assessment Test (RCAT) (Scores range from 6 to 30, with higher scores indicating better rhinitis symptom control.)
7 weeks
Minimal clinically important difference (MCID) in the severity of itching
Délai: 7 weeks

Minimal clinically important difference (MCID) in the severity of itching: Likelihood of experiencing minimal clinically important difference in itch severity as assessed by ISS (scale 0-21; with higher scores equaling greater severity)
7 weeks

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Radicle Science

Les enquêteurs

  • Chercheur principal: Susan Hewlings, Radicle Science

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

8 octobre 2026

Achèvement primaire (Estimé)

8 octobre 2027

Achèvement de l'étude (Estimé)

8 octobre 2027

Dates d'inscription aux études

Première soumission

17 septembre 2026

Première soumission répondant aux critères de contrôle qualité

17 septembre 2026

Première publication (Réel)

23 septembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

23 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

17 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • RADX_P_2610_RFY

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

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

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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