RecruitingNot ApplicableNCT06975995

Effect of the Postbiotics on Complications Treatment in Elderly Hemodialysis Patients

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


Sponsor

Peking University First Hospital

Enrollment

60 participants

Start Date

Aug 1, 2024

Study Type

INTERVENTIONAL

Conditions

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. 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.


Eligibility

Min Age: 65 Years

Inclusion Criteria3

  • 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.

Exclusion Criteria3

  • 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.

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Interventions

DIETARY_SUPPLEMENTYi'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.


Locations(1)

Peking UFH

Beijing, Beijing Municipality, China

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NCT06975995


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