Study Evaluating the Effect of UCB8600 on Mast Cell Activation in the Human Gut (MASTGUT)
Study evaluating the effect of UCB8600 on mast cell activation in the human gut:
IBS is a disease characterized by abdominal pain and a change in stool. Treatment is limited to an adapted life style, dietary changes and medication to lessen cramps (spasmolytica), all of which have seen limited to no clinical success.
Recently, we were able to demonstrate that mast cells play an active role in IBS symptoms. More specifically, they set histamine free when activated which heightens nerve sensitivity in the intestines which probably contributes to the abdominal pain. A new product called "UCB8600" is hypothesized to be able to counteract this by causing less mast cells to be activated. In this study we'll test this by administering UCB8600 on intestinal tissue and see if there is less mast cell activation. If the study produces good results, this new product could potentially be used as a treatment for IBS in the future.
調査の概要
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：Ine De Booser, MSc
- 電話番号：0032-16-341943
- メール：ine.debooser@uzleuven.be
研究場所
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Vlaams-Brabant
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Leuven、Vlaams-Brabant、ベルギー、3000
- University Hospitals Leuven
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コンタクト：
- Ine De Booser, MSc
- 電話番号：0032-16-341943
- メール：ine.debooser@uzleuven.be
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参加基準
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 group 1 (resection tissue surgery patients = healthy volunteers):
- Voluntary written informed consent of the participant has been obtained prior to any screening procedures
- At least 18 years of age at the time of signing the Informed Consent Form (ICF)
- Undergoing surgery for colorectal cancer
- No preoperative radiotherapy or chemotherapy
Exclusion Criteria group 1 (resection tissue surgery patients = healthy volunteers):
- Using anti-histaminics such as ebastine, cetirizine, desloratadine, … (non-exhautive list) at the moment of surgery
- Inflammatory bowel disease (IBD) or diverticulitis
- Diabetes or BMI ≥ 30 kg/m²
- Subject is legally incapacitated
Inclusion Criteria group 2 (rectal biopsies from IBS patients):
- Voluntary written informed consent of the subject has been obtained prior to any screening procedures
- At least 18 years of age at the time of signing the Informed Consent Form (ICF) and maximum age of 65 years of age at the time of signing the ICF
- Diagnosed with IBS
Exclusion Criteria group 2 (rectal biopsies from IBS patients):
- Subject has internal/external hemorrhoids at the moment of biopsy sampling.
- Using blood-thinners such as Acenocoumarol, Aspirine (acetylsalicylzuur), Apixaban (Eliquis), Clopidogrel (Plavix), Dabigatran (Pradaxa), Edoxaban (Lixiana), Rivaroxaban (Xarelto), warfarine (Marevan®) and Enoxaparine (Clexane), … (non-exhausative list).
- Using anti-histaminics such as ebastine, cetirizine, desloratadine, … (non-exhausative list) at the moment of biopsy sampling. Anti-histaminics should be stopped 2 weeks prior to the biopsy sampling.
- Subject is legally incapacitated
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：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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他の：Donation of resection material
Collection of colonic resection material of subjects undergoing abdominal surgery due to malignancies
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Collection of colonic resection material (surgery patients) and rectal biopsies (IBS patients)
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他の：Rectal biopsies
Collection of rectal biopsies of IBS patients
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Collection of colonic resection material (surgery patients) and rectal biopsies (IBS patients)
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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
結果測定 |
メジャーの説明 |
時間枠 |
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Total percentage of degranulated mast cells, detected using fluorescence microscopy
時間枠：After finishing the essay, approximately on day 2
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Using an avidin essay and fluorescence microscopy, the percentage of degranulated mast cells will be quantified
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After finishing the essay, approximately on day 2
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Total corrected cellular fluorescence (TCCF) per mast cell
時間枠：After finishing the essay, approximately on day 2
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Using an avidin essay and fluorescence microscopy, the TCCF per mast cell will be quantified
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After finishing the essay, approximately on day 2
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Guy Boecxkstaens, prof. dr.、Catholic University Leuven and Universitary Hospitals Leuven
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
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。
Sample collectionの臨床試験
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Cliniques universitaires Saint-Luc- Université...Université de Liège募集
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The Institute of Molecular and Translational Medicine...Cancer Research Czech Republic完了