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New feeding strategy aims to cut pneumonia in severe stroke

NCT ID NCT05998902

Disease control Sponsor: Wen Jiang-3 Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a combination of small amounts of tube feeding plus extra nutrition through an IV could reduce pneumonia in people with severe stroke. The trial enrolled 546 adults who had trouble swallowing. Researchers compared this approach to standard full tube feeding. The goal was to see if the mixed method lowers infection risk and improves recovery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Trophic enteral feeding combined with supplemental parenteral nutrition
What this could lead to
If successful, this nutrition strategy could lower the chance of pneumonia after severe stroke and improve recovery.
What could go wrong
This is a completed Phase 3 trial, but results are not yet published. The approach may not reduce pneumonia or improve outcomes for all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

546 people

The number who actually took part.

Started

Dec 2023

Finished

May 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age≥18 years 2. Definite diagnosis of acute stroke (GCS ≤12 or NIHSS≥11) 3. The randomized nutritional treatment could be initiated up to 72 hours after symptom onset. 4. Any cases of profiles #3 through 5 in Water Swallowing Test or with disorder of consciousness. 5. Plan to receive nutritional support treatment for at least 7 days. 6. Informed consent. Exclusion Criteria: 1. Receiving parenteral nutrition support 2. Contraindications of enteral nutrition 3. Complicated with the disease which only have life expectancy \< 7 days 4. Admission with infection signs 5. Dementia or severe disability (mRS\>4) before stroke 6. Antibiotics were used within the previous 7 days 7. Subarachnoid hemorrhage, cerebral arteriovenous malformation 8. Presence of coexisting medical conditions that could interfere with outcome assessment and/or follow-up (a. advanced cancer; b. severe pulmonary dysfunction \[forced expiratory volume in 1 second \< 50% or/and moderate to severe acute lung injury (PaO2/FiO2)\<200mmHg\]; c. cardiac insufficiency (NYHA class \> I; cardiac structural and/or functional abnormalities such as EF\< 50%, abnormal cardiac chamber enlargement, moderate/severe ventricular hypertrophy, or moderate/severe valvular stenosis); d. Severe liver failure \[Child-Pugh score≥7\]; e. Severe renal failure \[glomerular filtration rate ≤30mL/min or serum creatinine ≥4mg/dL\] 9. Currently participating in other clinical trial 10. Pregnant woman 11. Patient who is considered highly likely not to adhere to the study treatment or follow-up protocol.

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Conditions

The condition(s) this trial relates to.

Deglutition Disorders pneumonia stroke disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute stroke Dysphagia Severe stroke

Contacts and locations

Locations

  • Chongqing University Three Gorges Hospital

    Chongqing, Chongqing Municipality, 404100, China

  • Daping Hospital, The Third Military Medical University

    Chongqing, Chongqing Municipality, China

  • Department of Neurology, Xijing Hospital

    Xi'an, Shaanxi, China

  • First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, China

  • Gansu Provincal Central Hospital

    Lanzhou, Gansu, China

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia, 750000, China

  • Liaocheng People's Hospital

    Liaocheng, Shandong, 252000, China

  • Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong, China

  • People's Hospital of Xinjiang Uygur Autonomous Region

    Ürümqi, Xinjiang, 830000, China

  • Qilu Hospital of Shangdong University

    Jinan, Shandong, China

  • Shaanxi Second Provincal People's Hospital

    Xi'an, Shaanxi, 710000, China

  • Shannxi Provincal People's Hospital

    Xi'an, Shaanxi, China

  • Tangdu Hospital

    Xi'an, Shaanxi, 710000, China

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang, Guizhou, 550000, China

  • The First Affiliated Hospital of Xi'an Medical University

    Xi'an, Shaanxi, China

  • The First Hospital of Changsha City

    Changsha, Hunan, China

  • The First People's Hospital of Xianyang

    Xianyang, Shaanxi, China

  • The PLA 960 Hospital

    Jinan, Shandong, China

  • The Second Affiliated Hospital of Guangzhou University of Chinese Medicine

    Guangzhou, Guangdong, China

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330000, China

  • The Second Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, 830000, China

  • The Second Hospital of Shandong University

    Jinan, Shandong, China

  • The first affiliated hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, 710000, China

  • Tongji Hospital

    Wuhan, Hubei, China

  • Xi'an Central Hospital

    Xi'an, Shaanxi, 710000, China

  • Xi'an Gaoxin Hospital

    Xi'an, Shaanxi, China

  • Xi'an No.3 Hospital

    Xi'an, Shaanxi, China

  • Xianyang Hospital, Yan'an University

    Xianyang, Shaanxi, 712000, China

  • Yulin No.1 Hospital

    Yulin, Shaanxi, China

  • Yulin No.2 Hospital

    Yulin, Shaanxi, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.