The Effect of a Probiotic Intervention in Healthy Subjects and Patients With Atopic Dermatitis
Intervention Study on the Effects of a Probiotic Yoghurt Drink on the Immune System and Further Physiological Parameters in Patients With Atopic Dermatitis and Healthy Persons
調査の概要
詳細な説明
Recent studies suggest that oral bacteriotheraphy with probiotic bacteria might be useful to alleviate atopic dermatitis in infants. There are few indications about the effect of probiotics in the management of atopic dermatitis in adults.
As a precondition for participating in this study, the subjects were provided information in writing and verbally about the details of the study. Informed consent was obtained from all volunteers. Before the beginning of the study, all participants were subject to a medical examination in the Clinic for Dermatology and Dermatologic Allergology of the Friedrich Schiller University Jena. The AD was diagnosed according to the atopy-score of Diepgen. Severity of eczema was evaluated by using the SCORAD score. A skin prick test was performed for the exclusion of type 1 sensitivity to cow's milk.
The study was designed as a placebo-controlled and cross-over study. After a 3-week run-in period the 30 participants (15 healthy subjects and 15 patients with AD) were randomized to receive either 200 ml/d of a probiotic drink containing L. paracasei Lpc-37, L. acidophilus 74-2 and B. lactis 420 or 200 ml/d of a placebo drink for 8 weeks. After a 2-week washout period the intervention was crossed between the groups and the respective products were consumed for another 8 weeks followed by a 2-week washout period. Venous blood and fresh stool samples were collected before the beginning and at the end of each period. In AD patients the Scoring of atopic dermatitis (SCORAD) was assessed by the same physician every 4 weeks and 2 weeks after the wash-out period, respectively.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Thuringia
-
Jena、Thuringia、ドイツ、07743
- University of Jena, Institute of Nutrition, Department of Nutritional Physiology
-
-
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:
Healthy subjects:
- No allergic asthma
- No allergic rhinoconjunctivitis
- No food allergies
- Exclusion of atopic diathesis (< 7 points in Erlangen atopy score)
Patients with AD:
- Clear diagnosis of atopic dermatitis (> 10 points in the Erlangen atopy score) or flexural eczema or pruritis for at least 12 months (recidivating or permanent)
- SCORAD 5-30 (minor or medium AD)
- Willingness to apply for the duration of the study exclusively the cosmetic products recommended by the accompanying doctor and to use the recommended class II corticosteroid (Advantan) as further therapy of AD (for example during an episode)
Exclusion Criteria:
- Pregnancy, lactation
- Immune suppressive or cytostatic therapy or systemic steroids < 1 month before the first intake
- Phototherapy or systemic therapy of AD < 1 month before the first intake
- Active infections of the skin
- Relevant asthma disease, which must be treated with inhalative corticoids (FEV1 < 70 %)
- Patients with an indigestibility of/allergy against the components of milk/lactose intolerance (previously known or detected in the allergy test)
- Patients under long-term treatment with systemic steroids, depot steroids, long-acting antihistamines, tranquilizers, psychopharmaceuticals
- Intake of antihistamines, psychopharmaceuticals with antihistaminic effect and application of steroid containing cream to the forearms within the past 7 days before prick testing resp. treatment of the patient with Astemizol (Hismanal) within 4 weeks before the test. Such patients must be excluded from the study because of the long half-life of the medicament.
- Acute or chronic symptomatic heart disease or severe internistic diseases
- Autoimmune diseases, immune deficiencies (including immune suppressive treatment)
- Immune-complex-induced immunopathies or malignant tumors
- Abuse of alcohol, drugs or medicaments
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：処理
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Probiotic
intervention
|
Lactobacillus paracasei Lpc-37, Lactobacillus acidophilus 74-2 Bifidobacterium animalis subsp.
lactis DGCC 420
|
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 |
時間枠 |
|---|---|
|
SCORAD change in patients with AD taken at baseline and after 4 and 8 weeks, respectively -change in phagocytic and oxidative burst activity of monocytes and granulocytes at baseline and after 8 weeks
時間枠：8 weeks
|
8 weeks
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
cellular and humoral immunological parameters (CD's; Interleukins); detection of bacterial species in faecs, faecal short-chain fatty acids, blood lipids
時間枠：8 weeks
|
8 weeks
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Gerhard Jahreis, Prof. Dr.、University of Jena, Dept. of Nutritional Physiology
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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
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。