A Specific Probiotic in thE MOdulation of Gut Microbiota of patieNts With Mild-to-modErate Ulcerative Colitis (ANEMONE)
A. M in thE MOdulation of Gut Microbiota of patieNts With Mild-to-modErate Ulcerative Colitis: a Pilot,Phase 2A, Single-arm, Interventional Study
調査の概要
詳細な説明
The concept of probiotics dates back to 1907, when Elie Metchnikoff observed that elderly Bulgarian populations consuming fermented dairy products, such as yogurt rich in lactic acid bacteria (LAB), appeared to have increased longevity. This observation formed the basis for the development of traditional probiotics.
Traditional probiotics are defined as live microorganisms that confer a health benefit when administered in adequate amounts. These microbes are typically derived from fermented foods or the human gastrointestinal tract. Most belong to a limited number of well-characterized genera, particularly Lactobacillus and Bifidobacterium. Certain strains of these bacteria are recognized as safe and have been granted Qualified Presumption of Safety (QPS) status by the European Food Safety Authority (EFSA). In addition, they are technologically robust, meaning they can be easily cultivated and mass-produced for industrial applications.
Despite their popularity and widespread use in dietary supplements and functional foods, traditional probiotics are not specifically developed as treatments for diseases. Their mechanisms of action include modulation of gut microbiota, enhancement of the gut barrier, and interaction with the immune system. However, most supporting evidence comes from laboratory (in vitro), animal, or ex vivo studies rather than strong clinical trials. As a result, EFSA has evaluated more than 400 probiotic-related claims but has not approved any specific health claims due to insufficient conclusive evidence.
In recent years, advances in microbiota and microbiome research-particularly through metagenomics and microbial profiling-have significantly expanded our understanding of the gut ecosystem. It is now well established that dysbiosis, or imbalance in gut microbiota composition, is associated with a wide range of diseases, including metabolic, immune, and inflammatory disorders.
These scientific developments have led to the identification of new microorganisms that are associated with healthy individuals rather than traditional dietary sources. These microbes are classified as Next-Generation Probiotics (NGPs) or Live Biotherapeutic Products (LBPs). Unlike traditional probiotics, NGPs are not restricted to classical genera and do not have a long history of safe human use. Instead, they are often identified through comparative studies analyzing differences between healthy and diseased microbiomes.
NGPs represent a promising new frontier in microbiota-based therapies, as they may be specifically selected or engineered to target particular diseases or health conditions. A growing number of potentially beneficial species have been identified, opening new opportunities for precision medicine and personalized interventions based on gut microbiota composition.
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：Antonio Gasbarrini
- 電話番号：0630157104
- メール：antonio.gasbarrini@unicatt.it
研究場所
-
-
RM
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Roma、RM、イタリア、00146
- 募集
- Fondazione Policlinico Universitario Agostino Gemelli, IRCCS
-
コンタクト：
- Antonio Gasbarrini
- 電話番号：0630157104
- メール：antonio.gasbarrini@unicatt.it
-
-
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:
- Men or women 18 to 80 years of age at the time of consent
- Previous diagnosis of ulcerative colitis, based on available endoscopic and histopathologic report, at least 3 months before screening
- Mild-to-moderate disease activity based on Modified Mayo Score that should be between 4 and 6 with an endoscopic subscore >1 based on endoscopic evaluation performed during screening phase
- Subjects are permitted to receive a concomitant therapeutic dose of the following IPs: Corticosteroids (≤20 mg/day of prednisone equivalents) at stable dose for at least 2 weeks before screening and mesalazine or other 5-ASA (including salazopyrin) at stable dose for at least 4 weeks before screening
- Ability to provide a written informed consent and to be compliant with the schedule of protocol assessments.
Exclusion Criteria:
- concomitant immunosuppressive therapy, including but not limited to thiopurines, methotrexate, anti-TNFalfas, anti-integrins and anti-IL12/23 or JAK inhibitors. Biological therapies should be stopped at least 8 weeks before baseline, except for ustekinumab which should be stopped for at least 12 weeks before baseline, small molecules agent should be discontinued 5 elimination half-lives within baseline. Patients that have been previously treated with ≥ 2 advanced/biological drugs (even if belonging to the same class) will be excluded.
- Intolerance to topical therapy (enemas)
- Allergy to A. muciniphila or any other component of the IP
- Crohn's disease or inflammatory bowel disease unclassified (IBD-U)
- Subject who received IV/intramuscular corticosteroids within 14 days prior to Screening or during the Screening period.
- Subject who received topical therapy (i.e., enema or suppository of aminosalicylates / corticosteroids) within 14 days prior to Screening or during the Screening period.
- Subject who received fecal microbial transplantation within 3 months prior to Baseline.
Subjects with the following chronic or active infections:
- Active, chronic, or recurrent infection that based on the Investigator's clinical assessment makes the subject unsuitable candidate for the study
- Infection with C. difficile, intestinal pathogen bacteria, intestinal parasites as identified during Screening as per clinical practice,
- Are infected with human immunodeficiency virus (HIV),
- Subject who has any condition including any physical, psychological, or psychiatric condition, which in the opinion of the Investigator, would compromise the safety of the subject or the quality of the data and renders the subject an unsuitable candidate for the study.
- Pregnancy and breastfeeding
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：診断
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- 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 |
|---|---|
|
実験的：Type of patients
patients with UC and CD
|
For the collection of a few additional biopsies
rectal administration of a specific probiotic
|
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 |
|---|---|---|
|
Evaluate the effect of rectal administered a specific probiotic in Rectal mucosal healing
時間枠：1 year
|
The primary aim of this study is to evaluate the effect of rectal administered a specific probiotic on gut microbiota in patients with UC and CD for Rectal Mucosal Healing with mayo score.
Rectal mucosal healing assessed by Mayo Endoscopic Subscore (MES) (range 0-3; lower scores indicate better mucosal healing and lower disease activity).
|
1 year
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
evaluate the feasibility of a specific probiotic
時間枠：1 year
|
To evaluate the feasibility of a specific probiotic rectal administration in a cohort of patients with mild-to-moderate ulcerative colitis by nursing notes
|
1 year
|
|
Evaluate the tolerability of rectal a specific probiotic in Rectal Mucosal healing
時間枠：1 year
|
Tolerability of rectally administered probiotic assessed by the incidence of adverse events and treatment discontinuations.
|
1 year
|
|
Evaluate the quality of life
時間枠：1 year
|
Quality of life assessed by the Inflammatory Bowel Disease Questionnaire (IBDQ) (range 32-224; higher scores indicate better quality of life).
|
1 year
|
協力者と研究者
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
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