Comparing two feeding methods for patients with cerebral small vessel disease and swallowing difficulties
A Randomized Controlled Study to Explore the Clinical Effect of Multifunctional Nutrition Tube Feeding vs. Nasogastric Tube Feeding on Cerebral Small Vessel Disease Patients
This study is testing whether a new feeding method called Intermittent Oro-esophageal Tube Feeding helps patients with swallowing difficulties due to cerebral small vessel disease do better than the traditional Nasogastric Tube Feeding.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 88 (estimated) |
| Ages | 40 Years to 70 Years |
| Sex | All |
| Sponsor | People's Hospital of Zhengzhou University Academic / other |
| Locations | 1 site (Ban Phon Ko) |
| Trial ID | NCT06265857 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of Intermittent Oro-esophageal Tube Feeding (IOE) compared to Nasogastric Tube Feeding (NGT) in patients with cerebral small vessel disease (CSVD) who experience dysphagia. A total of 60 patients will be randomly assigned to receive either IOE or NGT while undergoing comprehensive rehabilitation therapy. The study will assess various outcomes, including dysphagia severity, nutritional status, quality of life, and incidence of pneumonia, using standardized assessment tools. The goal is to determine if IOE provides better clinical outcomes than NGT in this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 40 to 70 with a clinical diagnosis of cerebral small vessel disease and dysphagia requiring enteral nutrition support.
Not a fit: Patients with dysphagia due to other cerebrovascular or neurodegenerative diseases, or those with severe comorbid conditions, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved feeding methods that enhance recovery and quality of life for patients with dysphagia due to cerebral small vessel disease.
How similar studies have performed: While there is existing research on enteral feeding methods, this specific comparison of IOE versus NGT in CSVD patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Clinical diagnosis of CSVD, confirmed by MRI; * Must be able to cooperate with treatment and questionnaire investigation, (Generally with a Mini-Mental State Examination (MMSE) score ≥ 24) ; * Clinical diagnosis of dysphagia through the Functional Oral Intake Scale (FOIS) and Video Fluoroscopic Swallowing Study (VFSS); * Age between 40 and 70 years; * Enteral nutrition support was required and feasible. * No history of prior stroke. Exclusion Criteria: * Dysphagia related to other cerebrovascular diseases or caused by neurodegenerative diseases; * Complicated with severe liver and kidney failure, tumors, or hematological disorders; * Simultaneously need to undergo other therapy that might affect the outcomes of this study; * Pregnant or nursing females.
Where this trial is running
Ban Phon Ko
- Thai Rehabilitation Community Center — Ban Phon Ko, Thailand (Recruiting)
Study contacts
- Study coordinator: Hongjia Zhao, Master
- Email: 535226944@qq.com
- Phone: 17695841016
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.