Radicle GI Health™ RFY: A 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
Radicle GI Health™ RFY: A Randomized, Double-Blind, Placebo-Controlled Study Assessing the Impact of DAO Supplementation on Gastrointestinal and other Histamine Intolerance Symptoms.
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Study Manager
- 電話番号：858-779-0086
- メール：studymgmt@radiclescience.com
研究連絡先のバックアップ
- 名前：Susan Hewlings
- 電話番号：760-281-3898
- メール：susan.hewlings@radiclescience.com
研究場所
-
-
California
-
Del Mar、California、アメリカ、92014
- Radicle Science, Inc
-
コンタクト：
- Study Manager
- 電話番号：760-281-3898
- メール：studymgmt@radiclescience.com
-
コンタクト：
- Megan Moseley
- メール：megan@radiclescience.com
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
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Resides in the United States
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Report histamine intolerance symptoms affecting GI health and at least one other organ/system, determined from the Histamine Intolerance Checklist
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Has the opportunity for at least 30% improvement in their primary health outcome
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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
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Reports current enrollment in another clinical trial
-
Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day)
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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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Active GI Health Product 1
Active GI Health Product 1 |
Participants will use their Active GI Health Product 1 as directed for a period of 6 weeks |
|
プラセボコンパレーター：Placebo GI Health Control
Placebo GI Health Control |
Participants will use their Placebo GI Health Control as directed for a period of 6 weeks |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in the severity of gastrointestinal symptoms
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in GI-related Quality of Life (QOL)
時間枠：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
時間枠：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
時間枠：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
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Minimal clinically important difference (MCID) in the severity of gastrointestinal symptoms
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Susan Hewlings、Radicle Science
出版物と役立つリンク
便利なリンク
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- RADX_P_2610_RFY
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
Data will not be shared with researchers outside of Radicle Collaborators on this study.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。