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NCT Number: NCT07353658

Effect of Intermittent Enteral Feeding in Severe Stroke

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.

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Key information

Conditions

Severe Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Enteral Nutrition Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. All-cause mortality

    Time frame: 90 days post-randomization

Secondary outcomes

  1. 90-day unfavorable outcome rate

    Time frame: at 90 days

    Defined as a modified Rankin Scale (mRS) score of 3-6

  2. Neurological deficit score

    Time frame: at Day 3 and Day 7 post-randomization

    National Institutes of Health Stroke Scale (NIHSS) score

  3. Activities of daily living

    Time frame: 90 days post-randomization

    Barthel Index (BI)

  4. Nutritional status indicators

    Time frame: Baseline and Day 7 assessments

    Serum albumin (ALB); Serum prealbumin (PAB); Serum total protein (TP); Hemoglobin (HB) levels; Mid-upper arm circumference (MUAC); Triceps skinfold thickness (TSF)

  5. Incidence of gastrointestinal intolerance

    Time frame: Throughout the intervention period (expected ≥7 days)

    Gastric retention; diarrhea; constipation and gastrointestinal bleeding

  6. Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: Throughout the study period (up to 90-day follow-up).

Study contacts

Contact information is provided by the study sponsor or research team.

Jingjing Zhao

CONTACT

[email protected]

18192829590

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Official study title

The Effect of Intermittent Versus Continuous Enteral Feeding on Outcomes in Severe Stroke: An Exploratory Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 20, 2026
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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