Effect of Intermittent Enteral Feeding in Severe Stroke

NCT07353658 | Not Yet Recruiting DMC

• 1 other identifier: KY20252538jiangwen
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a single-center, randomized, exploratory clinical trial investigating whether intermittent enteral feeding improves outcomes compared to continuous feeding in patients with severe stroke. The study will enroll 60 patients to evaluate the impact on 90-day all-cause mortality, neurological function, nutritional status, and safety. It will also explore underlying mechanisms through analysis of metabolic profiles, circadian gene expression, and gut microbiota.

Conditions

Severe Stroke; Enteral Nutrition

Keywords

Stroke; Enteral Nutrition

Outcome Measures

Primary Outcomes (1)

• All-cause mortality

  90 days post-randomization

Secondary Outcomes (6)

• 90-day unfavorable outcome rate

  at 90 days

• Neurological deficit score

  at Day 3 and Day 7 post-randomization

• Activities of daily living

  90 days post-randomization

• Nutritional status indicators

  Baseline and Day 7 assessments

• Incidence of gastrointestinal intolerance

  Throughout the intervention period (expected ≥7 days)

Study Arms (2)

Intermittent Enteral Nutrition Group

EXPERIMENTAL

Behavioral: Intermittent Enteral Feeding

Continuous Enteral Nutrition Group

ACTIVE COMPARATOR

Behavioral: Continuous Enteral Feeding

Interventions

Intermittent Enteral Feeding BEHAVIORAL

Participants randomized to this group will receive enteral nutrition via a nasogastric or nasojejunal tube using an intermittent, daytime-only feeding schedule designed to align with the physiological circadian rhythm.

Intermittent Enteral Nutrition Group

Continuous Enteral Feeding BEHAVIORAL

Participants randomized to this group will receive enteral nutrition via a nasogastric or nasojejunal tube using the standard, continuous 24-hour feeding method commonly employed in critical care settings.

Continuous Enteral Nutrition Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years old
• It was definitely diagnosed as acute stroke by clinical imaging.
• Enteral nutrition program can be started within 72 hours of onset.
• Baseline GCS≤12 or NIHSS≥11
• There is nutritional risk (NRS 2002≥3), Wadian drinking water test≥ 3 or there is consciousnessdisorder,it is estimated that you need to receive nutritional support treatment for ≥7 days
• Obtain informed consent

You may not qualify if:

• Before joining the group, he had received total parenteral nutrition treatment.
• There are contraindications to enteral nutrition.
• Unstable vital signs
• Dementia or severe disability before onset (mRS≥3)
• There are concomitant diseases that will interfere with outcome evaluation and/or follow-up.
• Participating in other interventional clinical trials.
• Other circumstances in which the study cannot be completed.

Sponsors & Collaborators

• Xijing Hospital: lead

Related Publications (12)

• Reignier J, Plantefeve G, Mira JP, Argaud L, Asfar P, Aissaoui N, Badie J, Botoc NV, Brisard L, Bui HN, Chatellier D, Chauvelot L, Combes A, Cracco C, Darmon M, Das V, Debarre M, Delbove A, Devaquet J, Dumont LM, Gontier O, Groyer S, Guerin L, Guidet B, Hourmant Y, Jaber S, Lambiotte F, Leroy C, Letocart P, Madeux B, Maizel J, Martinet O, Martino F, Maxime V, Mercier E, Nay MA, Nseir S, Oziel J, Picard W, Piton G, Quenot JP, Reizine F, Renault A, Richecoeur J, Rigaud JP, Schneider F, Silva D, Sirodot M, Souweine B, Tamion F, Terzi N, Thevenin D, Thiery G, Thieulot-Rolin N, Timsit JF, Tinturier F, Tirot P, Vanderlinden T, Vinatier I, Vinsonneau C, Voicu S, Lascarrou JB, Le Gouge A; NUTRIREA-3 Trial Investigators; Clinical Research in Intensive Care; Sepsis (CRICS-TRIGGERSEP)Group. Low versus standard calorie and protein feeding in ventilated adults with shock: a randomised, controlled, multicentre, open-label, parallel-group trial (NUTRIREA-3). Lancet Respir Med. 2023 Jul;11(7):602-612. doi: 10.1016/S2213-2600(23)00092-9. Epub 2023 Mar 20.

  PMID: 36958363 RESULT

• Zhao J, Yuan F, Song C, Yin R, Chang M, Zhang W, Zhang B, Yu L, Jia Y, Ma Y, Song Y, Wang C, Song C, Wang X, Shang L, Yang F, Jiang W; OPENS Trial Investigators. Safety and efficacy of three enteral feeding strategies in patients with severe stroke in China (OPENS): a multicentre, prospective, randomised, open-label, blinded-endpoint trial. Lancet Neurol. 2022 Apr;21(4):319-328. doi: 10.1016/S1474-4422(22)00010-2. Epub 2022 Feb 24.

  PMID: 35219379 RESULT

• Panwar R, Kumar N, Parikh H, Dash S, Rai S. Standard continuous feeding versus intermittent feeding among mechanically ventilated patients in intensive care: A systematic review and meta-analysis of randomized controlled trials. Clin Nutr. 2025 Aug;51:40-49. doi: 10.1016/j.clnu.2025.05.024. Epub 2025 Jun 7.

  PMID: 40516326 RESULT

• Zhu W, Jiang Y, Li J. Intermittent versus continuous tube feeding in patients with hemorrhagic stroke: a randomized controlled clinical trial. Eur J Clin Nutr. 2020 Oct;74(10):1420-1427. doi: 10.1038/s41430-020-0579-6. Epub 2020 Mar 9.

  PMID: 32152512 RESULT

• Arabi YM, Aldawood AS, Haddad SH, Al-Dorzi HM, Tamim HM, Jones G, Mehta S, McIntyre L, Solaiman O, Sakkijha MH, Sadat M, Afesh L; PermiT Trial Group. Permissive Underfeeding or Standard Enteral Feeding in Critically Ill Adults. N Engl J Med. 2015 Jun 18;372(25):2398-408. doi: 10.1056/NEJMoa1502826. Epub 2015 May 20.

  PMID: 25992505 RESULT

• Heyland DK, Cahill N, Day AG. Optimal amount of calories for critically ill patients: depends on how you slice the cake! Crit Care Med. 2011 Dec;39(12):2619-26. doi: 10.1097/CCM.0b013e318226641d.

  PMID: 21705881 RESULT

• Wong HJ, Harith S, Lua PL, Ibrahim KA. Prevalence and Predictors of Malnutrition Risk among Post-Stroke Patients in Outpatient Setting: A Cross-Sectional Study. Malays J Med Sci. 2020 Jul;27(4):72-84. doi: 10.21315/mjms2020.27.4.7. Epub 2020 Aug 19.

  PMID: 32863747 RESULT

• van Wijk N, Studer B, van den Berg CA, Ripken D, Lansink M, Siebler M, Schmidt-Wilcke T. Evident lower blood levels of multiple nutritional compounds and highly prevalent malnutrition in sub-acute stroke patients with or without dysphagia. Front Neurol. 2023 Jan 10;13:1028991. doi: 10.3389/fneur.2022.1028991. eCollection 2022.

  PMID: 36703642 RESULT

• Sharie SA, Almari R, Azzam S, Al-Husinat L, Araydah M, Battaglini D, Schultz MJ, Patroniti NA, Rocco PR, Robba C. Brain Protective Ventilation Strategies in Severe Acute Brain Injury. Curr Neurol Neurosci Rep. 2025 Oct 13;25(1):68. doi: 10.1007/s11910-025-01462-2.

  PMID: 41082009 RESULT

• Ma Q, Li R, Wang L, Yin P, Wang Y, Yan C, Ren Y, Qian Z, Vaughn MG, McMillin SE, Hay SI, Naghavi M, Cai M, Wang C, Zhang Z, Zhou M, Lin H, Yang Y. Temporal trend and attributable risk factors of stroke burden in China, 1990-2019: an analysis for the Global Burden of Disease Study 2019. Lancet Public Health. 2021 Dec;6(12):e897-e906. doi: 10.1016/S2468-2667(21)00228-0.

  PMID: 34838196 RESULT

• GBD 2021 Stroke Risk Factor Collaborators. Global, regional, and national burden of stroke and its risk factors, 1990-2021: a systematic analysis for the Global Burden of Disease Study 2021. Lancet Neurol. 2024 Oct;23(10):973-1003. doi: 10.1016/S1474-4422(24)00369-7.

  PMID: 39304265 RESULT

• Walter K. What Is Acute Ischemic Stroke? JAMA. 2022 Mar 1;327(9):885. doi: 10.1001/jama.2022.1420. No abstract available.

  PMID: 35230392 RESULT

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Jingjing Zhao

CONTACT

18192829590; zhaojing@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 25, 2025
• First Posted: January 20, 2026
• Study Start: January 5, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 20, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share