Effect of the Postbiotics on Complications Treatment in Elderly Hemodialysis Patients

NCT06975995 | Recruiting DMC

• 1 other identifier: Bio-EHD
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.In the treatment period for 12 weeks, intervention group receives postbiotics product while the other group receives placebo.
2. 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.

Conditions

Hemodialysis Complication

Outcome Measures

Primary Outcomes (6)

• Changes of nutritional status from the baseline to the 12th week of treatment period and differences between the intervention group and the placebo group.

  Nutritional status of the patient is defined as the results of physical examination and SGA-7 rating scale.

  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.

  Gastrointestinal symptoms of the patient is defined as the scores of gastrointestinal symptom rating scale (GSRS).

  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.

  Quality of life of the patient is defined as the scores of kidney disease life quality scale (SF-36) .

  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.

  Asthenia of the patients is defined as the scores of edmonton frail Scale (EFS).

  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.

  The BMI (kg/m2) of the patients.

  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.

  The dry weight of the patient is obtained from the bioelectrical impedance analysis.

  baseline, the 12th week of treatment period

Secondary Outcomes (6)

• Changes of IS level from baseline to the end of treatment and difference between the intervention and placebo group.

  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.

  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.

  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.

  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.

  baseline, the 12th week of treatment period

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

The intervention group will receive oral postbiotics product for 150ml per day during the treatment period (from week 1 to week 12). Then, the group will end the trial.

Dietary Supplement: Yi'en Yuan Honey Fermented Drink

Placebo group

PLACEBO COMPARATOR

The placebo group will receive oral placebo during the treatment period (from week 1 to week 12). Then, the group will enter into remedial the treatment period (from week 13 to week 24) and receive the same oral postbiotics product as intervention group for 150ml per day. The group will end the trial at week 24.

Dietary Supplement: Yi'en Yuan Honey Fermented Drink

Interventions

Yi'en Yuan Honey Fermented Drink DIETARY_SUPPLEMENT

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.

Intervention group; Placebo group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Peking UFH

Beijing, Beijing Municipality, 100034, China

RECRUITING

Study Officials

• Yuqing Chen

  Peking University First Hospital

  STUDY CHAIR

Central Study Contacts

Yuqing Chen

CONTACT

86-010-82572254; cyq@bjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2024
• First Posted: May 16, 2025
• Study Start: August 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 16, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)