Safety and User Experience of BP-CBB
A Placebo-controlled, Double-blind, Safety and Experience Evaluation of IgG Binding Protein CBB (BP-CBB)
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- 適用できない
連絡先と場所
研究連絡先
研究連絡先
- 名前:Emily Goodbody
- 電話番号:+353 (0) 86-218-8787
- メール:egoodbody@atlantiatrials.com
研究連絡先のバックアップ
- 名前:Emma Harrington
- 電話番号:+353 (0) 86-218-8787
- メール:eharrington@atlantiatrials.com
研究場所
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-
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Cork、アイルランド、T23 R50R
- Atlantia Clinical Trials
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参加基準
適格基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
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:トリプル
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
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実験的:Test arm
Receives Test product containing BP-CBB
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Dietary supplement containing BP-CBB
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プラセボコンパレーター:Placebo arm
Receives Placebo product without BP-CBB
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Receives dietary supplement without BP-CBB
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この研究は何を測定していますか?
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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To evaluate the safety and tolerability of once daily intake of the novel food ingredient BP-CBB in healthy adults
時間枠:8 weeks
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Incidence of all AEs per arm by product causality.
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8 weeks
|
協力者と研究者
協力者
協力者
捜査官
捜査官
- 主任研究者:Martin Buckley, Professor、Atlantia Clinical Trials
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
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
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
その他の研究ID番号
- AFCRO-204
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?
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
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