Clinical trial NCT06328829: Intermittent Oral Tube in Alzheimer's Patients
Official title: Clinical Observation of Intermittent Oral-esophageal Tube Feeding in Alzheimer's Patients With Dysphagia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Alzheimer Disease
Lead sponsor: Chao Phya Abhaibhubejhr Hospital
Sponsor class: OTHER_GOV
First posted: 2024-03-25
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Concentration of Hemoglobin
timeFrame: day 1 and day 15
measure: Concentration of Serum albumin
timeFrame: day 1 and day 15
measure: Concentration of Total serum protein
timeFrame: day 1 and day 15
measure: Concentration of Serum prealbumin
timeFrame: day 1 and day 15
measure: Body Mass Index
timeFrame: day 1 and day 15
Secondary outcomes:
measure: Pulmonary Infections
timeFrame: day 1 and day 15
measure: Mini Nutritional Assessment
timeFrame: day 1 and day 15
measure: Standardized Swallowing Assessment
timeFrame: day 1 and day 15
Other outcomes:
Locations:
Study officials:
affiliation: Site Coordinator of United Medical Group
name: Nieto Luis
role: STUDY_CHAIR
References: