Effect of the Postbiotics on Complications Treatment in Elderly Hemodialysis Patients

Официальное название

A Postbiotics Improves the Quality of Life and Nutritional Status in Elderly Hemodialysis Patients

Обзор

The purpose of the trial is to explore the effect of exogenous postbiotics supply on the quality of life and nutritional status of elderly hemodialysis patients. Participants will be devided into intervention group and placebo group in an 1:1 ratio.They will: 1. In the treatment period for 12 weeks, intervention group receives postbiotics product while the other group receives placebo. 2. In the subsequent 12 weeks, intervention group ends the trial and placebo group enters into remedial treatment period. Placebo group will receive postbiotics product for 12 weeks. Researchers will analyze the change of indicators such as quality of life and nutrition state of participants from the baseline to end of treatment, and compare the difference between the two group.

Подробное описание

Intestinal flora imbalance has a high prevalence in CKD patients and is closely invloved with CKD complications like malnutrition and anemia, which affects quality of life and long-term prognosis of CKD patients. Probiotics is the bioactive compound produced by probiotics when it consumes prebiotics. It can alleviate the condition and improve quality of life of patients by regulating growth of microbiota directly and indirectly and inhibiting growth of pathogenic microorganism. The purpose of the trial is to explore the effect of exogenous postbiotics supply on the quality of life and nutritional status of elderly hemodialysis patients.

The study is a multicenter prospective open-labled and randomized controlled trial. Elderly patients with age ≥65 years and received hemodialysis treatment for more than 6 months will be included in the study. During the screen period, the patients with medical history that might affect oral feeding or gastrointestinal functions will be excluded.

After enrollment, the patients will be educated about how to keep diet records and then they will be randomly divided into group A (intervention group) and group B (placebo group) in an 1:1 ratio. The patients in group A will receive oral postbiotics and group B receive placebo. The treatment period is 12 weeks. Subsequently, group A ends the trial, and group B enters the remedial treatment period, receiving oral postbiotics, and the treatment cycle is 12 weeks.

At 0, 12 and 24 weeks quality of life score, nutrition evaluation, diet status and gastrointestinal symptom score respectively will be evaluated. The stool and serum of patients will be collected for intestinal flora and urotoxins measurements. Besides, the trial will collect routine biochemical indicators. The investigators will analyze those indicators above from the baseline to end of treatment and compare the difference between intervention group and placebo group.

Вмешательства

• Пищевая добавка Yi'en Yuan Honey Fermented Drink
  The oral postbiotics product used in the trial is called Yi'en Yuan Honey Fermented Drink. The product is made from water, edible brown sugar, and honey as raw materials. It is fermented by a mixture of plant lactic acid bacteria and coagulating Bacillus, and then inactivated at high temperature. The product meets the food and beverage standard. Participants will receive the product for 150ml per day.

Первичные конечные точки

• Changes of nutritional status from the baseline to the 12th week of treatment period and differences between the intervention group and the placebo group. [Срок оценки: baseline, the 12th week of treatment period]
• Changes of gastrointestinal symptoms from the baseline to the 12th week of treatment period and differences between the intervention group and the placebo group. [Срок оценки: baseline, the 12th week of treatment period]
• Changes of quality of life from the baseline to the 12th week of treatment period and differences between the intervention group and the placebo group. [Срок оценки: baseline, the 12th week of treatment period]
• Changes of asthenia of the patients from the baseline to the 12th week of treatment period and differences between the intervention group and the placebo group. [Срок оценки: baseline, the 12th week of treatment period]
• Changes of body mass index from the baseline to the 12th week of treatment period and differences between the intervention group and the placebo group. [Срок оценки: baseline, the 12th week of treatment period]
• Changes of dry weight from the baseline to the 12th week of treatment period and differences between the intervention group and the placebo group. [Срок оценки: baseline, the 12th week of treatment period]

Вторичные конечные точки (6)

• Changes of IS level from baseline to the end of treatment and difference between the intervention and placebo group. [Срок оценки: baseline, the 12th week of treatment period]
• Changes of TMAO level from baseline to the end of treatment and difference between the intervention and placebo group. [Срок оценки: baseline, the 12th week of treatment period]
• Changes of PCS level from baseline to the end of treatment and difference between the intervention and placebo group. [Срок оценки: baseline, the 12th week of treatment period]
• Changes of hemoglobin from the baseline to the end of treatment, and differences between the intervention group and the placebo group. [Срок оценки: baseline, the 12th week of treatment period]
• Changes of albumin from the baseline to the end of treatment, and differences between the intervention group and the placebo group. [Срок оценки: baseline, the 12th week of treatment period]
• Changes of BUN from the baseline to the end of treatment, and differences between the intervention group and the placebo group. [Срок оценки: baseline, the 12th week of treatment period]

Критерии участия

Критерии включения

Investigators must maintain a screening log of all potential study candidates that includes limited information about the potential candidate, date, and outcome of the screening process (e.g. enrolled into study, reason for ineligibility, or refused to participate). After signing an informed consent form, potential patients must meet all of the criteria:

• Age ≥65 years.
• Receiving maintenance hemodialysis therapy for at least 6 months.

Критерии исключения

The following exclusion criteria must NOT be present for each subject:

• Subjects with medical history that might affect oral feeding (e.g. intestinal obstruction, gastrointestinal bleeding, acute pancreatitis and accidental inhalation) within the last 1 month prior to screening.
• Subjects with medical history that might affect gastrointestinal functions (e.g. inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), short bowel syndrome (SBS), et al.).
• Subjects who cannot communicate and collaborate normally.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Peking UFH — Пекин

Идентификаторы

NCT: NCT06975995 · Bio-EHD

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗