Enteral Nutrition and Colonization Resistance Through Microbiota Modulation in Critically Ill Patients (MICRON)
2026年7月20日 更新者：Andra-Elena Goicea、Iuliu Hatieganu University of Medicine and Pharmacy
Enteral Nutrition to Enhance Colonization Resistance Through Gut Microbiota Modulation in Critically Ill Patients: A Randomized Controlled Pilot Trial
The goal of this clinical trial is to learn whether enteral nutrition enriched with fiber can influence gut microbiota and improve resistance to colonization with multidrug-resistant bacteria in critically ill patients. The study will also evaluate the safety and clinical outcomes associated with fiber-enriched enteral nutrition.
The main questions it aims to answer are:
- Does fiber-enriched enteral nutrition reduce the acquisition of colonization with multidrug-resistant bacteria during intensive care unit (ICU) hospitalization?
- Does fiber-enriched enteral nutrition modify the composition and diversity of the intestinal microbiota?
- Are there differences in clinical outcomes, including adverse events, between patients receiving fiber-enriched and non-fiber enteral nutrition?
Researchers will compare patients receiving fiber-enriched enteral nutrition with patients receiving standard enteral nutrition without added fiber to determine whether fiber supplementation influences gut microbiota and colonization resistance.
Participants will:
- Receive enteral nutrition through a feeding tube according to their clinical needs.
- Receive either a fiber-enriched enteral nutrition formula or a standard enteral nutrition formula.
- Have stool samples collected during ICU hospitalization for analysis of intestinal microbiota and detection of multidrug-resistant bacteria.
- Be monitored for clinical outcomes, infections, antibiotic exposure, and adverse events during their ICU stay and follow-up period.
調査の概要
状態
まだ募集していません
詳細な説明
Critically ill patients frequently experience alterations of the intestinal microbiota due to factors such as severe illness, antibiotic exposure, and the ICU environment. These changes may contribute to loss of colonization resistance and increased susceptibility to acquisition of multidrug-resistant bacteria, which are associated with increased morbidity and mortality in critically ill populations.
Enteral nutrition is commonly used in ICU patients who are unable to meet their nutritional requirements orally. Beyond its role in providing calories and nutrients, enteral nutrition may influence intestinal barrier function and microbiota composition. Fiber-containing enteral formulas include nondigestible carbohydrates that may act as substrates for microbial fermentation and may promote the growth of beneficial bacterial populations and the production of short-chain fatty acids.
Previous studies have suggested that fiber supplementation during enteral nutrition may influence gut microbiota composition and clinical outcomes; however, results remain inconsistent, particularly in critically ill patients receiving broad-spectrum antibiotics. The potential effect of fiber-enriched enteral nutrition on acquisition of multidrug-resistant bacterial colonization has not been adequately investigated.
This clinical trial aims to evaluate whether modulation of the intestinal microbiota through fiber-enriched enteral nutrition may influence colonization resistance in critically ill patients. The study will provide preliminary data regarding microbiota changes associated with enteral nutrition strategies and their potential relationship with multidrug-resistant bacterial colonization. These findings may support the design of future larger clinical trials evaluating nutritional interventions as a strategy to preserve microbiome function and reduce ICU-associated complications.
研究の種類
介入
入学 (推定)
60
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Daniel Corneliu Leucuța
- 電話番号：+40-597256 int 2501
- メール：dleucuta@umfcluj.ro
研究場所
-
-
-
Cluj-Napoca、ルーマニア
- Emergency Military Clinical Hospital "Dr. Constantin Papilian" Cluj-Napoca
-
コンタクト：
- Andra Elena Goicea
- 電話番号：+40723712665
- メール：goiceaandraelena@elearn.umfcluj.ro
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
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
いいえ
説明
Inclusion Criteria:
- Patients with medical (non-surgical) conditions admitted to the ICU.
- ICU admission within the previous 48 hours at the study site.
- Initiation of enteral nutrition within the first 48 hours after ICU admission.
- Written informed consent obtained for participation in the study.
Exclusion Criteria:
- Surgical ICU patients.
- Patients in whom enteral nutrition was not initiated within the first 48 hours after - ICU admission.
- Patients with galactosemia.
- Patients with major contraindications to enteral nutrition, including: intestinal obstruction, intestinal ischemia, intestinal perforation, severe hemodynamic instability, patients who refuse participation in the study.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：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：Fiber-Enriched Enteral Nutrition
Participants will receive an enteral nutrition formula containing dietary fiber according to the study protocol.
|
Participants will receive enteral nutrition administered through an enteral feeding tube according to their clinical nutritional requirements.
The intervention consists of an enteral nutrition formula enriched with dietary fiber, including fermentable fibers with potential prebiotic effects, intended to modulate intestinal microbiota composition and function.
It will be administered according to the study protocol and clinical care requirements of critically ill patients.
The intervention will be initiated during intensive care unit hospitalization and continued according to patient tolerance and clinical indications.
The type and amount of enteral nutrition administered will be documented throughout the study period.
他の名前：
|
|
アクティブコンパレータ：Standard Enteral Nutrition Without Fiber
Participants will receive an enteral nutrition formula without added dietary fiber according to the study protocol.
|
Participants will receive enteral nutrition administered through an enteral feeding tube according to their clinical nutritional requirements.
The comparator intervention consists of a standard enteral nutrition formula without added fiber.
It will be administered according to the study protocol and clinical care requirements of critically ill patients.
The type and amount of enteral nutrition administered will be documented throughout the study period.
他の名前：
|
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 |
|---|---|---|
|
Proportion of Participants With New Multidrug-Resistant Bacterial Colonization Between Days 5 and 7
時間枠：ICU days 5-7 after admission
|
Proportion of participants who acquire new colonization with multidrug-resistant bacteria (MDRB) during ICU hospitalization, assessed between study days 5 and 7. New colonization will be defined as detection of MDRB not present at baseline (day 0) based on microbiological surveillance samples.
|
ICU days 5-7 after admission
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Gut Microbiota Diversity and Composition
時間枠：From ICU admission (Day 1) to ICU days 5-7
|
Changes in intestinal microbiota diversity and composition between baseline and follow-up samples, assessed by microbiome analysis of stool samples.
|
From ICU admission (Day 1) to ICU days 5-7
|
|
Proportion of Participants With MDRO Colonization at Day 14 and 28
時間枠：Day 14 and 28 after ICU admission
|
Proportion of participants with MDRB colonization detected on surveillance microbiological samples among participants who continue receiving enteral nutrition.
|
Day 14 and 28 after ICU admission
|
|
Incidence of Nosocomial Infections
時間枠：From ICU admission (Day 1) to hospital discharge or Day 28, whichever occurs first
|
Incidence and type of nosocomial infections occurring during ICU hospitalization.
|
From ICU admission (Day 1) to hospital discharge or Day 28, whichever occurs first
|
|
Duration of Mechanical Ventilation and Ventilator-Free Days
時間枠：Day 28 after ICU admission
|
Duration of invasive mechanical ventilation and number of ventilator-free days during the first 28 days after ICU admission.
|
Day 28 after ICU admission
|
|
Duration of ICU and Hospital Stay
時間枠：ICU stay: From ICU admission through ICU discharge, an average of 28 days; Hospital stay: From hospital admission through hospital discharge, an average of 90 days.
|
Duration of intensive care unit stay and total hospital length of stay.
|
ICU stay: From ICU admission through ICU discharge, an average of 28 days; Hospital stay: From hospital admission through hospital discharge, an average of 90 days.
|
|
28-Day Mortality and In-Hospital Mortality
時間枠：28-Day Mortality: 28 days after ICU admission; In-Hospital Mortality: during the hospital stay, up to hospital discharge, up to 90 days.
|
All-cause mortality occurring within 28 days after ICU admission and during the index hospital admission.
|
28-Day Mortality: 28 days after ICU admission; In-Hospital Mortality: during the hospital stay, up to hospital discharge, up to 90 days.
|
|
Correlation Between Immunological and Inflammatory Profile Changes and MDRB Colonization or Microbiota Changes
時間枠：From ICU admission (Day 1) to Day 28 after ICU admission
|
Correlation between longitudinal changes in inflammatory and immunological markes, and changes in MDRB colonization status and intestinal microbiota composition.
Biomarkers will include routine laboratory parameters (e.g., leukocyte differential count, C-reactive protein, fibrinogen, erythrocyte sedimentation rate, ferritin) and immunological markers (e.g., immunoglobulins IgA, IgG, IgM, IgE, complement C3 and C4), and will be reported using their respective standard clinical laboratory units.
MDRB colonization will be assessed by microbiological culture and reported for ESBL-producing organisms, CRE, MRSA, VRE.
Intestinal microbiota composition will be characterized by next-generation sequencing and reported using taxonomic relative abundance and diversity indices.
|
From ICU admission (Day 1) to Day 28 after ICU admission
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- スタディチェア：Constantin Bodolea、"Iuliu Hațieganu" University of Medicine and Pharmacy Cluj-Napoca
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Caparros T, Lopez J, Grau T. Early enteral nutrition in critically ill patients with a high-protein diet enriched with arginine, fiber, and antioxidants compared with a standard high-protein diet. The effect on nosocomial infections and outcome. JPEN J Parenter Enteral Nutr. 2001 Nov-Dec;25(6):299-308; discussion 308-9. doi: 10.1177/0148607101025006299.
- Koch JL, Lew CCH, Kork F, Koch A, Stoppe C, Heyland DK, Dresen E, Lee ZY, Hill A. The efficacy of fiber-supplemented enteral nutrition in critically ill patients: a systematic review and meta-analysis of randomized controlled trials with trial sequential analysis. Crit Care. 2024 Nov 7;28(1):359. doi: 10.1186/s13054-024-05128-2.
- Andersen S, Kennedy G, Banks M, Flanagan B, Henden A. Prebiotic fiber enteral supplementation after allogeneic transplantation: feasibility and impact on the microbiome. Blood Adv. 2025 Aug 26;9(16):4167-4179. doi: 10.1182/bloodadvances.2024015703.
- O'Keefe SJ, Ou J, Delany JP, Curry S, Zoetendal E, Gaskins HR, Gunn S. Effect of fiber supplementation on the microbiota in critically ill patients. World J Gastrointest Pathophysiol. 2011 Dec 15;2(6):138-45. doi: 10.4291/wjgp.v2.i6.138.
- Freedberg DE, Messina M, Lynch E, Tess M, Miracle E, Chong DH, Wahab R, Abrams JA, Wang HH, Munck C. Impact of Fiber-Based Enteral Nutrition on the Gut Microbiome of ICU Patients Receiving Broad-Spectrum Antibiotics: A Randomized Pilot Trial. Crit Care Explor. 2020 Jun 11;2(6):e0135. doi: 10.1097/CCE.0000000000000135. eCollection 2020 Jun.
- Majid HA, Cole J, Emery PW, Whelan K. Additional oligofructose/inulin does not increase faecal bifidobacteria in critically ill patients receiving enteral nutrition: a randomised controlled trial. Clin Nutr. 2014 Dec;33(6):966-72. doi: 10.1016/j.clnu.2013.11.008. Epub 2013 Nov 16.
- Serbanescu MA, Wright MC, Elebasy M, Shi P, Arnold JW, Haines KL, White JR, Surana NK, Wischmeyer PE. Impact of fiber-containing enteral nutrition on microbial community dynamics in critically ill trauma patients: a pilot-randomized trial. BMC Med. 2025 Dec 29;23(1):706. doi: 10.1186/s12916-025-04511-2.
- Fu Y, Moscoso DI, Porter J, Krishnareddy S, Abrams JA, Seres D, Chong DH, Freedberg DE. Relationship Between Dietary Fiber Intake and Short-Chain Fatty Acid-Producing Bacteria During Critical Illness: A Prospective Cohort Study. JPEN J Parenter Enteral Nutr. 2020 Mar;44(3):463-471. doi: 10.1002/jpen.1682. Epub 2019 Aug 6.
- Kamarul Zaman M, Chin KF, Rai V, Majid HA. Fiber and prebiotic supplementation in enteral nutrition: A systematic review and meta-analysis. World J Gastroenterol. 2015 May 7;21(17):5372-81. doi: 10.3748/wjg.v21.i17.5372.
- Krezalek MA, Yeh A, Alverdy JC, Morowitz M. Influence of nutrition therapy on the intestinal microbiome. Curr Opin Clin Nutr Metab Care. 2017 Mar;20(2):131-137. doi: 10.1097/MCO.0000000000000348.
- Goicea AE, Leucuta DC, Bodolea C. Gut Microbiota Alterations Associated With Colonization by Multidrug-Resistant Organisms in ICU Patients: First Systematic Review and Meta-Analysis. Microbiologyopen. 2026 Jun;15(3):e70322. doi: 10.1002/mbo3.70322.
- Choy A, Freedberg DE. Impact of microbiome-based interventions on gastrointestinal pathogen colonization in the intensive care unit. Ther Adv Gastroenterol. 2020 Jul 17;13:1756284820939447. doi: 10.1177/1756284820939447. eCollection 2020.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年10月1日
一次修了 (推定)
2027年10月1日
研究の完了 (推定)
2027年12月1日
試験登録日
最初に提出
2026年7月14日
QC基準を満たした最初の提出物
2026年7月20日
最初の投稿 (実際)
2026年7月22日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月22日
QC基準を満たした最後の更新が送信されました
2026年7月20日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- DEP227/25.06.2026
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?
いいえ
IPD プランの説明
Individual participant data will not be shared because the study involves a relatively small number of critically ill patients and includes detailed clinical and microbiological information that may present privacy and confidentiality risks.
Data will be handled according to applicable ethical and data protection requirements.
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
いいえ
米国FDA規制機器製品の研究
いいえ
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。