細菌ライセートを使用した気道感染症および喘鳴から早産児を保護します。 (PROTEA)
中等度後期の早産児を生後 1 年間の呼吸器感染症および喘鳴から細菌溶解物を使用して保護する。
The primary objective of this study is to reduce respiratory tract infections and wheezing in moderate-late preterms in the first years of life by bacterial lysate administration. Next to determine the correlation of biological markers with respiratory symptoms, immune protection and treatment effect.
調査の概要
詳細な説明
This is a randomised placebo-controlled trial including 500 otherwise healthy moderate-late preterm infants. Participants will receive bacterial lysate (OM-85/Broncho-Vaxom, 3,5mg) or placebo powder for ten days each month, from 6-10 weeks after birth until 12 months after birth. At 12 months, parents of participants are asked to join in Protea-2. If they do, participants in the treatment arm of year 1 are randomised again over placebo and OM-85 and treated until the age of 24 months. Clinical data will be continuously collected by e-Health and 3 (possibly digital) study visits; with optional biological sampling and lung function at baseline, 6 and 12 months.
Main study parameters are doctor diagnosed lower RTI and wheezing episodes in the first year of life. Biological sampling will allow investigation of immune maturation, as well as microbiome development in the respiratory tract and gut. Also, biomarkers for risk-group selection and/or treatment success will be examined.
研究の種類
入学 (推定)
段階
- フェーズ 3
連絡先と場所
研究連絡先
- 名前：Gerdien Tramper, MD PhD
- 電話番号：0031 10 4617126
- メール：proteastudie@franciscus.nl
研究場所
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South Holland
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Rotterdam、South Holland、オランダ、3045PM
- 募集
- Franciscus Gasthuis & Vlietland
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コンタクト：
- Gerdien Tramper, MD PhD
- 電話番号：+311046117126
- メール：proteastudie@franciscus.nl
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コンタクト：
-
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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 Criteria:
- Gestational age at delivery between 30+0 and 35+6 weeks
- Postnatal age at least 6 weeks at randomization & postmenstrual age at least 37 weeks
- Written informed consent by both parents or formal caregivers
Exclusion Criteria:
- Underlying other severe respiratory disease such as broncho-pulmonary dysplasia (unexpected in this group); hemodynamic significant cardiac disease; immunodefi-ciency; severe failure to thrive; birth asphyxia with predicted poor neurological out-come; syndrome or serious congenital disorder.
- Maternal TNF-alpha inhibitors or other immunosuppression during pregnancy and/or breastfeeding
- Parents unable to speak and read Dutch/English language
- Known allergic hypersensitivity to the active ingredients/substance or to any of the excipients.
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：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：Broncho-Vaxom treatment
Infants in this arm will be given 3,5mg bacterial lysate (OM-85) 10 days per month from 6 weeks after birth until 12 months of age. At age 12 months they will be (if informed consent for Protea-2 is provided) randomised over Broncho-Vaxom treatment and placebo again. |
Broncho-Vaxom is a bacterial extract comprising lyophilised fractions of 21 different inactivated bacterial strains, which are frequently causing RTI.
他の名前：
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プラセボコンパレーター：Placebo
Infants in this arm will be given a placebo powder from a capsule that will be indistinguishable from the active study drug. |
Placebo powder from a capsule will be given, which will be indistinguishable from the active study drug. |
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 |
|---|---|---|
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Total number of physician diagnosed lower RTI and wheezing episodes in the first year of life
時間枠：In the first year of life.
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Recorded by frequent questionnaires |
In the first year of life.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Time to first lower RTI or wheezing episode
時間枠：In the first and second year of life.
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Recorded by short weekly questionnaires (which will be filled in during the first year of life) and more extensive questionnaires every six months in the first and second year of life. |
In the first and second year of life.
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Total number of RTI
時間枠：In the first and second year of life.
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Recorded by short weekly questionnaires (which will be filled in during the first year of life) and more extensive questionnaires every six months in the first and second year of life. |
In the first and second year of life.
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Total number of wheezing episodes
時間枠：In the first and second year of life.
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Recorded by short weekly questionnaires (which will be filled in during the first year of life) and more extensive questionnaires every six months in the first and second year of life. |
In the first and second year of life.
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Distribution of viruses
時間枠：In the first year of life.
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Viruses present in the nasofarynx during complaints of lower respiratory tract infection or wheezing. Nasofaryngeal swabs will be taken in case of complaints during the first year of life. In the second year of life this will not be done. |
In the first year of life.
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Medication use (bronchodilators, corticosteroids, antibiotics)
時間枠：In the first and second year of life.
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Recorded by short weekly questionnaires (which will be filled in during the first year of life) and more extensive questionnaires every six months in the first and second year of life. |
In the first and second year of life.
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Lung function as measured by expiratory variability index (Ventica)
時間枠：In the first year of life.
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Measured at age 6-10 weeks (baseline), 6 months and 12 months in a subset of participants. |
In the first year of life.
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Quality of life questionnaires
時間枠：In the first and second year of life.
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Recorded by extensive questionnaires every six months in the first and second year of life. |
In the first and second year of life.
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(serious) adverse events
時間枠：In the first year of life.
|
Will be reported by parents immediately. Respiratory episodes are not regarded as an (S)AE since these episodes comprise primary and secondary outcomes. (S)AE's are only expected in the first year of life because the treatment stops at the age of 12 months. |
In the first year of life.
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Serum specific IgE (allergen sensitization) at 12 months
時間枠：At age 12 months
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Total IgE and house dust mite specific IgE |
At age 12 months
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Infant vaccination titers at 12 months
時間枠：At age 12 months
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Vaccination titers of haemohilus influenza type B, pneumococci, tetanus |
At age 12 months
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Costs- and cost-effectiveness
時間枠：In the first and second year of life.
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Estimated from information from standardized questionnaires |
In the first and second year of life.
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Gut and respiratory microbiome composition
時間枠：In the first year of life.
|
Measured from faeces and nasofaryngeal swabs taken at age 6-10 weeks, 6 months and 12 months. |
In the first year of life.
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Secretory IgA in saliva or nasal lining fluid
時間枠：In the first year of life
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Saliva will be collected at age 6-10 weeks, 6 months and 12 months. |
In the first year of life
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Immune maturation: immune cells in nasal epithelium
時間枠：In the first year of life
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Collected by nasal scraping at age 6-10 weeks, 6 months and 12 months. Analysed using masscytometry. |
In the first year of life
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Immune maturation: chemokines and cytokines in nasal lining fluid
時間枠：In the first year of life
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Collected by nasosorption at age 6-10 weeks, 6 months and 12 months. Analysed using Luminex cyto/chemokine assay. |
In the first year of life
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Immune maturation: immune cells in bloodsamples
時間枠：In the first year of life
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Collected by blooddraws at age 6-10 weeks, 6 months and 12 months. Analysed using masscytometry. |
In the first year of life
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Serum IgE (total and specific to house dust mite)
時間枠：At age 12 months
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Measured in blood samples which will be drawn at age 12 months |
At age 12 months
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Immune maturation: Single cell transcriptomics
時間枠：At age 12 months
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Performed on blood drawn at age 12 months |
At age 12 months
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Whole blood stimulation essays
時間枠：At age 12 months
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Performed on blood drawn at age 12 months |
At age 12 months
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Biomarkers predictive of high morbidity and/or treatment success
時間枠：In the first year of life.
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From combined microbial and immunological data |
In the first year of life.
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協力者と研究者
出版物と役立つリンク
一般刊行物
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研究記録日
主要日程の研究
研究開始 (実際)
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
追加の関連 MeSH 用語
その他の研究ID番号
- NL76165.100.20
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
Researchdata will be shared in data repositories according to the FAIR principle. Clinical data about respiratory health will be shared in the DANS repository. Inlcuding metadata which will ensure reusability. Sequencing data will be shared online in the ENA repository which will provide an unique global identifier. All used bioinformatics pipelines for data analysis will be made accessible on a GitHub account. Immunological data will be shared in NCBI Gene Expression omnibus and ImmPort. Used analysis pipelines for the transcriptomics data will also be tracked and can be shared using a Github account.
All data shared will be pneudonymized.
IPD 共有時間枠
Data will come available after publication of the data in articles by initating researchers.
IPD 共有アクセス基準
Data will be available under restricted access. A request for data sharing will include at least the reason for request (for what will the receiver use the data?) and agreements about authorship.
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。