Oral Enteral Nutrition Feeding in Alzheimer's Patients

A Randomly Controlled Study to Explore Oral vs Nasal Enteral Nutrition Feeding in Alzheimer's Patients

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Alzheimer Disease
• Intervention / Treatment: Behavioral: Conventional Care; Device: Intermittent Oral-esophageal Tube Feeding; Device: Nasogastric tube

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lavie Ce, Master; Phone Number: 15333828388; Email: zenghongjixx@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intermittent Oral-esophageal Tube Feeding group; This 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	Behavioral: Conventional Care; Basic treatment, including corresponding control of risk factors and education on healthy lifestyles. Swallowing training, including lemon ice stimulation, mendelson maneuver, empty swallowing training, and pronunciation training. Pulmonary function training, including standing training, cough training, and diaphragm muscle training.; Device: Intermittent Oral-esophageal Tube Feeding; Before each feeding, inside and outside of the tube was cleaned with water. During feeding, the patient should maintain a semi-reclining or sitting position with mouth opened, and the tube was inserted slowly and smoothly into the upper part of the esophagus by medical staffs while the appropriate depth of intubation was checked with the calibration markings on the tube wall. The distance from the incisors to the head part of the tube should be between 22-25 cm. However, the specific depth should be evaluated based on patients' feedback and adjusted accordingly. After insertion, the tail part of the tube should be put into a container full of water and the absence of continuous bubbles indicated a successful intubation. Then, the feeding was to be conducted three times per day with 50 ml per minute and 400-600ml for each feeding.
Active Comparator: Nasogastric tube group; This 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	Behavioral: Conventional Care; Basic treatment, including corresponding control of risk factors and education on healthy lifestyles. Swallowing training, including lemon ice stimulation, mendelson maneuver, empty swallowing training, and pronunciation training. Pulmonary function training, including standing training, cough training, and diaphragm muscle training.; Device: Nasogastric tube; Within 4 hours after admission, the placement of the feeding tube was conducted by professional medical staffs and after intubation, the tube was secured to the patient's cheek with medical tape. 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's condition and relevant guidelines to reach the energy demand as 20-25 kcal/kg/day and protein supplementation of 1.2-2.0 g/kg/day for both two groups. For patients with limited tube feeding compliance, we made appropriate adjustments to ensure that they were not at risk of severe malnutrition as much as possible.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of Hemoglobin	Hemoglobin was recorded through the blood routine test. (g/L)	day 1 and day 15
Level of Serum albumin	Serum albumin was recorded through the blood routine test. (g/L)	day 1 and day 15
Level of Total serum protein	Total serum protein was recorded through the blood routine test. ( g/L)	day 1 and day 15
Level of Serum prealbumin	Serum prealbumin was recorded through the blood routine test.(g/L)	day 1 and day 15

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Mass Index	Body Mass Index was assessed with the combination of body weight and height: weight (kg)/ [height (m)] ^2	day 1 and day 15
Pulmonary Infections	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.	day 1 and day 15
Mini Nutritional Assessment	Mini Nutritional Assessment is used for assessment of nutritional status, ranging 0 to 30. A higher score indicates the better nutritional status	day 1 and day 15

Collaborators and Investigators

• Sponsor: Muhammad
• Investigators: Study Chair: Nieto Luis, Master, Site Coordinator of United Medical Group

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: March 4, 2024
• First Submitted That Met QC Criteria: March 4, 2024
• First Posted (Actual): March 8, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 8, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: Tube-Alzheimer

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