DysphagiaIOEfinalNCT07386834
Large-Scale Study of Oro-esophageal Feeding Versus Nasogastric Feeding for Swallowing Function and Airway Protection
A study testing Oro-esophageal Feeding, Nasogastric Feeding and Rehabilitation care in people with Dysphagia, run by Zeng Changhao.
Trial summary
This is a randomized controlled trial involving patients with ischemic stroke and dysphagia. The aim of this study is to explore the recovery speed and therapeutic effect of oro-esophageal feeding compared with nasogastric feeding on swallowing function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysphagia
- What is being tested?
- Oro-esophageal Feeding, Nasogastric Feeding and Rehabilitation care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 422 participants
- Where
- No sites listed yet
- Study dates
- Mar 2026to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age>18 years.
- First stroke
- Disease duration less than one month.
- Ischemic stroke.
- Patients who need enteral feeding.
- Dysphagia confirmed by imaging Study.
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- Clear consciousness.
- Stable vital signs.
- With informed consent and participants who understand and agree to comply with planned study procedures.
Who cannot join
- Dysphagia that might be caused by other diseases or structural abnormalities.
- Complicated with severe liver and kidney failure, tumors, or hematological disorders.
- Contraindications for tube feeding.
- Pregnancy or breast feeding.
- Anticipated discharge from the hospital or transfer to another hospital within two week.
About this study
Official title: The Effect of Oro-esophageal Versus Nasogastric Feeding for Stroke Patients With Dysphagia: A Multicenter Randomized Controlled Large-Scale Study
This is a randomized controlled trial involving patients with ischemic stroke and dysphagia. The aim of this study is to explore the recovery speed and therapeutic effect of oro-esophageal feeding compared with nasogastric feeding on swallowing function. This study mainly addresses the following two research questions: 1. Whether oro-esophageal feeding improves swallowing function more rapidly and effectively than nasogastric tube feeding. 2. Whether oro-esophageal feeding is non-inferior to nasogastric tube feeding in terms of safety.
Read the detailed description
This is a randomized controlled trial involving patients with ischemic stroke and dysphagia. The aim of this study is to explore the recovery speed and therapeutic effect of oro-esophageal feeding compared with nasogastric feeding on swallowing function. This study mainly addresses the following two research questions: 1. Whether oro-esophageal feeding improves swallowing function more rapidly and effectively than nasogastric tube feeding. 2. Whether oro-esophageal feeding is non-inferior to nasogastric tube feeding in terms of safety.
The intervention period will last for two weeks, with an additional four-week follow-up observation period. This is a multicenter study to be conducted across multiple hospitals.
- Conditions
- Dysphagia
- Being tested
- Oro-esophageal Feeding, Nasogastric Feeding, Rehabilitation care
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oro-esophageal FeedingDietary supplement
Medical staff inserts the tube slowly and smoothly into the upper esophagus, verifying the correct insertion depth by referencing the calibration marks on the tube wall. The distance from the incisors to the tube's tip should range from 22 to 25 cm. Following insertion, the distal end of the tube is submerged in a container of water, and the absence of continuous bubbling confirms successful intubation. Feeding is subsequently administered three times daily at a rate of 50 mL per minute, with a volume of 400 to 600 mL per feeding. The intervention period lasts for a total of two weeks.
Nasogastric FeedingDietary supplement
The feeding was conducted once every 3-4 hours, with 200-300ml each time. The total feeding volume was determined based on daily requirements. The feeding content was formulated by the nutritionists based on the patient condition and relevant guidelines to reach the energy demand as 20-35 kcal/kg/day and daily protein demand of patients through the determination of 24-h urinary urea for both two groups.The intervention period lasts for a total of two weeks.
Rehabilitation careBehavioural
All patients will receive rehabilitation care according to the standard of care for the trial site hospital. All these interventions are performed in accordance with the Chinese Guidelines for Stroke Rehabilitation and the Chinese Guidelines for Dysphagia Rehabilitation. The intervention period lasts for a total of two weeks.
| Study group | Role | What they receive |
|---|---|---|
| Oro-esophageal Group | Experimental | Participants will receive oro-esophageal feeding plus rehabilitation therapy in accordance with stroke rehabilitation guidelines, with the specific content determined by the participating centers, for 14 days and being hospitalized. Receives: Dietary Supplement: Oro-esophageal Feeding; Behavioral: Rehabilitation care |
| Nasogastric Group | Active comparator | Participants will receive Nasogastric feeding plus rehabilitation therapy in accordance with stroke rehabilitation guidelines, with the specific content determined by the participating centers, for 14 days and being hospitalized. Receives: Dietary Supplement: Nasogastric Feeding; Behavioral: Rehabilitation care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dysphagia Outcome and Severity Scale
The Dysphagia Outcome and Severity Scale consists of 7 levels, from 1 to 7, based on imaging data. A higher level indicates better swallowing function.
Measured: Day 0 and day15
Secondary outcomes (6)
Time to improvement of one level and of the baseline Dysphagia Outcome and Severity Scale
The Dysphagia Outcome and Severity Scale consists of 7 levels, from 1 to 7, based on imaging data.
The investigators will record the time required for participants to achieve a one-grade improvement from the baseline Dysphagia Outcome and Severity Scale.
Measured: up to 2 weeks
Time to oral intake
The time to recovery is the first day, during the two weeks of the intervention period, on which a participant meets level 3, 4, 5, 6, or 7 on the Dysphagia Outcome and Severity Scale. The Dysphagia Outcome and Severity Scale consists of 7 levels, from 1 to 7, based on imaging data. A higher level indicates better swallowing function.
Measured: up to 2 weeks
Penetration-Aspiration Scale
The Penetration-Aspiration Scale is for assessing airway protection. It has 8 grades, grouped into 3 categories: no penetration/aspiration, penetration, aspiration. Lower grades = better function: Grade 1 is optimal (no airway entry); Grade 8 is most severe (food enters airway below vocal cords with no clearing effort).
Measured: Day 0 and day15
Murray Secretion Scale
The Murray Secretion Scale is used to evaluate the accumulation of secretions, in which grade 0 meant no obvious accumulation, and grade 3 meant secretions in the laryngeal vestibule. The Murray Secretion Scale has 4 grades. The higher grade indicates more severe accumulation of secretions.
Measured: Day 0 and day15
Yale Pharyngeal Residual Severity Rating Scale
The Yale Pharyngeal Residual Severity Rating Scale is used to evaluate pharyngeal residue after swallowing. The score could range between 1 and 5, with higher scores indicating worse situations.
Measured: Day 0 and day15
Aspiration
Aspiration is based on self-reporting, caregiver monitoring, or the diagnosis of aspiration pneumonia, defined as the coughing and discomfort caused by food or water entering the airway for various reasons. The numbers of aspiration will be recorded.
Measured: up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study startMar 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 422 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zeng Changhao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zeng Changhao, People's Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07386834
- Sponsor's protocol ID
- IOElastreport
- Acronym
- IOEfinal
- Status last verified
- Mar 2026
- First submitted
- 26 Jan 2026
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang M, Xia C, Lu Y, Zeng H, Liu H, Zhao W, Wang L, Zeng X, Yang Y. Effects of oro-esophageal versus nasogastric feeding on dysphagia for ischemic stroke survivors: study protocol for a randomized controlled trial. Front Nutr. 2026 Apr 29;13:1830508. doi: 10.3389/fnut.2026.1830508. eCollection 2026.
PubMed 42137858
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oro-esophageal Versus Nasogastric Feeding for Stroke Patients With Dysphagia: A Multicenter Randomized Controlled Large-Scale Study
- ClinicalTrials.gov ID
- NCT07386834
- Acronym / sponsor ID
- IOEfinal / IOElastreport
- Conditions
- Dysphagia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 422 participants (estimated)
- Lead sponsor
- Zeng ChanghaoUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 4 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized controlled trial involving patients with ischemic stroke and dysphagia. The aim of this study is to explore the recovery speed and therapeutic effect of oro-esophageal feeding compared with nasogastric feeding on swallowing function. This study mainly addresses the following two research questions: 1. Whether oro-esophageal feeding improves swallowing function more rapidly and effectively than nasogastric tube feeding. 2. Whether oro-esophageal feeding is non-inferior to nasogastric tube feeding in terms of safety.
Detailed description
This is a randomized controlled trial involving patients with ischemic stroke and dysphagia. The aim of this study is to explore the recovery speed and therapeutic effect of oro-esophageal feeding compared with nasogastric feeding on swallowing function. This study mainly addresses the following two research questions: 1. Whether oro-esophageal feeding improves swallowing function more rapidly and effectively than nasogastric tube feeding. 2. Whether oro-esophageal feeding is non-inferior to nasogastric tube feeding in terms of safety.
The intervention period will last for two weeks, with an additional four-week follow-up observation period. This is a multicenter study to be conducted across multiple hospitals.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oro-esophageal Group | Experimental | Dietary Supplement: Oro-esophageal Feeding, Behavioral: Rehabilitation careParticipants will receive oro-esophageal feeding plus rehabilitation therapy in accordance with stroke rehabilitation guidelines, with the specific content determined by the participating centers, for 14 days and being hospitalized. |
| Nasogastric Group | Active comparator | Dietary Supplement: Nasogastric Feeding, Behavioral: Rehabilitation careParticipants will receive Nasogastric feeding plus rehabilitation therapy in accordance with stroke rehabilitation guidelines, with the specific content determined by the participating centers, for 14 days and being hospitalized. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age>18 years.
- First stroke
- Disease duration less than one month.
- Ischemic stroke.
- Patients who need enteral feeding.
Key exclusion criteria (5 listed)
- Dysphagia that might be caused by other diseases or structural abnormalities.
- Complicated with severe liver and kidney failure, tumors, or hematological disorders.
- Contraindications for tube feeding.
- Pregnancy or breast feeding.
- Anticipated discharge from the hospital or transfer to another hospital within two week.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oro-esophageal FeedingMedical staff inserts the tube slowly and smoothly into the upper esophagus, verifying the correct insertion depth by referencing the calibration marks on the tube wall. The distance from the incisors to the tube's tip should range from 22 to 25 cm. Following insertion, the distal end of the tube is submerged in a container of water, and the absence of continuous bubbling confirms successful intubation. Feeding is subsequently administered three times daily at a rate of 50 mL per minute, with a volume of 400 to 600 mL per feeding. The intervention period lasts for a total of two weeks. | Dietary supplement | Oro-esophageal Group |
| Nasogastric FeedingThe feeding was conducted once every 3-4 hours, with 200-300ml each time. The total feeding volume was determined based on daily requirements. The feeding content was formulated by the nutritionists based on the patient condition and relevant guidelines to reach the energy demand as 20-35 kcal/kg/day and daily protein demand of patients through the determination of 24-h urinary urea for both two groups.The intervention period lasts for a total of two weeks. | Dietary supplement | Nasogastric Group |
| Rehabilitation careAll patients will receive rehabilitation care according to the standard of care for the trial site hospital. All these interventions are performed in accordance with the Chinese Guidelines for Stroke Rehabilitation and the Chinese Guidelines for Dysphagia Rehabilitation. The intervention period lasts for a total of two weeks. | Behavioural | Nasogastric Group, Oro-esophageal Group |
Primary outcome
Dysphagia Outcome and Severity Scale
Time frame: Day 0 and day15
The Dysphagia Outcome and Severity Scale consists of 7 levels, from 1 to 7, based on imaging data. A higher level indicates better swallowing function.
6 secondary outcomes
Time to improvement of one level and of the baseline Dysphagia Outcome and Severity Scale
Time frame: up to 2 weeks
Time to oral intake
Time frame: up to 2 weeks
Penetration-Aspiration Scale
Time frame: Day 0 and day15
Murray Secretion Scale
Time frame: Day 0 and day15
Yale Pharyngeal Residual Severity Rating Scale
Time frame: Day 0 and day15
Aspiration
Time frame: up to 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Derived from this study: PubMed 42137858Wang M, Xia C, Lu Y, Zeng H, Liu H, Zhao W, Wang L, Zeng X, Yang Y. Effects of oro-esophageal versus nasogastric feeding on dysphagia for ischemic stroke survivors: study protocol for a randomized controlled trial. Front Nutr. 2026 Apr 29;13:1830508. doi: 10.3389/fnut.2026.1830508. eCollection 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Oro-esophageal Feeding, Nasogastric Feeding and Rehabilitation care in people with Dysphagia, run by Zeng Changhao.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dysphagia Outcome and Severity Scale (time frame: Day 0 and day15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07386834, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.