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Oral Enteral Nutrition Feeding in Alzheimer's Patients

Not Applicable
Not yet recruiting
Conditions
Alzheimer Disease
Interventions
Behavioral: Conventional Care
Device: Nasogastric tube
Device: Intermittent Oral-esophageal Tube Feeding
Registration Number
NCT06301750
Lead Sponsor
Muhammad
Brief Summary

This is a prospective multicenter study with Alzheimer's patients with dysphagia. Patients enrolled are randomly divided equally into the observation group and the control group. All patients receive conventional care, and the observation group received Intermittent Oral-esophageal Tube Feeding while the control group received Nasogastric Tube Feeding for enteral nutrition support. Baseline information (demographics, medical history, etc.), nutritional status at admission and after treatment, depression, dysphagia, and quality of life after treatment are compared.

Detailed Description

The Alzheimer's disease in the elderly exhibits the high prevalence.This is a prospective multicenter study with Alzheimer's patients with dysphagia. Patients enrolled are randomly divided equally into the observation group and the control group. All patients receive conventional care, and the observation group received Intermittent Oral-esophageal Tube Feeding while the control group received Nasogastric Tube Feeding for enteral nutrition support. Baseline information (demographics, medical history, etc.), nutritional status at admission and after treatment, depression, dysphagia, and quality of life after treatment are compared.

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
80
Inclusion Criteria
  • age between 18 years and 85 years, meeting the diagnosis of Alzheimer's Disease.
  • presence of no contraindication for enteral nutrition.
  • with dysphagia verified by Imaging materials.
  • with stable vital signs and no severe liver or kidney dysfunction, metabolic disorders, cardiovascular diseases, or multiple complications
  • Minimum Mental State Examination ranging from 10-26
Exclusion Criteria
  • unable to cooperate in completing treatment and assessment due to personal reasons or other disorders.
  • complicated with other intracranial lesions, such as stroke.
  • abnormal structure of swallowing-related organ and tissue.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Intermittent Oral-esophageal Tube Feeding groupConventional CareThis group is hospitalized, while conventional care and enteral nutrition support are provided to the two groups. The Intermittent Oral-esophageal Tube Feeding group receives Intermittent Oral-esophageal Tube Feeding for enteral nutrition support
Nasogastric tube groupConventional CareThis group is hospitalized, while conventional care and enteral nutrition support are provided to the two groups. The Nasogastric tube group receives Nasogastric Tube Feeding for enteral nutrition support
Nasogastric tube groupNasogastric tubeThis group is hospitalized, while conventional care and enteral nutrition support are provided to the two groups. The Nasogastric tube group receives Nasogastric Tube Feeding for enteral nutrition support
Intermittent Oral-esophageal Tube Feeding groupIntermittent Oral-esophageal Tube FeedingThis group is hospitalized, while conventional care and enteral nutrition support are provided to the two groups. The Intermittent Oral-esophageal Tube Feeding group receives Intermittent Oral-esophageal Tube Feeding for enteral nutrition support
Primary Outcome Measures
NameTimeMethod
Level of Serum albuminday 1 and day 15

Serum albumin was recorded through the blood routine test. (g/L)

Level of Total serum proteinday 1 and day 15

Total serum protein was recorded through the blood routine test. ( g/L)

Level of Serum prealbuminday 1 and day 15

Serum prealbumin was recorded through the blood routine test.(g/L)

Level of Hemoglobinday 1 and day 15

Hemoglobin was recorded through the blood routine test. (g/L)

Secondary Outcome Measures
NameTimeMethod
Pulmonary Infectionsday 1 and day 15

During the treatment, the occurrence of complications was recorded for both groups. These complications included but were not limited to: 1) Pulmonary Infections: Monitoring for the development of respiratory infections such as pneumonia or bronchitis.

Mini Nutritional Assessmentday 1 and day 15

Mini Nutritional Assessment is used for assessment of nutritional status, ranging 0 to 30. A higher score indicates the better nutritional status

Body Mass Indexday 1 and day 15

Body Mass Index was assessed with the combination of body weight and height: weight (kg)/ \[height (m)\] \^2

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