Effect of Intermittent Enteral Feeding in Severe Stroke

January 11, 2026 updated by: Xijing Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥18 years old
  2. It was definitely diagnosed as acute stroke by clinical imaging.
  3. Enteral nutrition program can be started within 72 hours of onset.
  4. Baseline GCS≤12 or NIHSS≥11
  5. 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
  6. Obtain informed consent

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intermittent Enteral Nutrition Group
Behavioral: Intermittent Enteral Feeding
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.
Active Comparator: Continuous Enteral Nutrition Group
Behavioral: Continuous Enteral Feeding
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
All-cause mortality
Time Frame: 90 days post-randomization
90 days post-randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
90-day unfavorable outcome rate
Time Frame: at 90 days
Defined as a modified Rankin Scale (mRS) score of 3-6
at 90 days
Neurological deficit score
Time Frame: at Day 3 and Day 7 post-randomization
National Institutes of Health Stroke Scale (NIHSS) score
at Day 3 and Day 7 post-randomization
Activities of daily living
Time Frame: 90 days post-randomization
Barthel Index (BI)
90 days post-randomization
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)
Baseline and Day 7 assessments
Incidence of gastrointestinal intolerance
Time Frame: Throughout the intervention period (expected ≥7 days)
Gastric retention; diarrhea; constipation and gastrointestinal bleeding
Throughout the intervention period (expected ≥7 days)
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Throughout the study period (up to 90-day follow-up).
Throughout the study period (up to 90-day follow-up).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 5, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

December 25, 2025

First Submitted That Met QC Criteria

January 11, 2026

First Posted (Actual)

January 20, 2026

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 11, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20252538jiangwen

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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