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Completed

NCT Number: NCT03265639

Prebiotics in Peritoneal Dialysis

The Prebiotics in Peritoneal Dialysis trial is a non-randomized, open-label, crossover study of p-inulin for patients with end-stage renal disease treated with peritoneal dialysis.

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Key information

Conditions

End Stage Renal Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gut Microbiome Dysbiosis Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

DaVita Georgetown Home Training Unit, Washington D.C., District of Columbia, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Peritoneal dialysis therapy for end-stage renal disease
  • ≥30 days since dialysis initiation
  • Ability to provide informed consent

Exclusion criteria

  • Use of pre- or pro-biotics during the past 2 months
  • Consumption of pro-biotic yogurt during the past 2 weeks
  • Use of antibiotics within the past 2 months
  • Presence of chronic infection
  • Chronic gastrointestinal condition other than constipation
  • Cirrhosis or chronic active hepatitis
  • Stomach/intestinal resection
  • PD access problems
  • Anticipated kidney transplant or transfer to another dialysis unit within 9 months
  • Expected survival < 9 months
  • Pregnancy, anticipated pregnancy, or breastfeeding
  • Incarceration
  • Participation in another intervention study
  • Severe anemia defined as hemoglobin <9.0 g/dl

Treatment and study plan

p-inulin

Dietary Supplement

Primary outcomes

  1. Change within-patient in the metabolomic profile and targeted metabolites / inflammatory markers during the no treatment phases and the p-inulin treatment phase.

    Time frame: 24 weeks

    Metabolomic Profile: the relative abundance of metabolites, determined by liquid chromatography-mass spectrometry (LC-MS), will be quantified under each condition and compared between groups.

Secondary outcomes

  1. Within-patient change in the metabolomic profile and targeted metabolites / inflammatory markers after p-inulin treatment compared with pre-treatment.

    Time frame: 24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)

    Metabolomic Profile: the relative abundance of metabolites, determined by liquid chromatography-mass spectrometry (LC-MS), will be quantified under each condition and compared between groups.

  2. Within-patient variability in the bacterial composition of the stool during the no treatment phase.

    Time frame: 24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)

    Bacterial Composition: the relative abundance of bacterial taxa, as determined by 16S rRNA gene sequencing, will be quantified.

  3. Within-patient variability in the bacterial composition of the stool during the p-inulin treatment phase.

    Time frame: 24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)

    Bacterial Composition: the relative abundance of bacterial taxa, as determined by 16S rRNA gene sequencing, will be quantified.

  4. Within-patient change in the bacterial composition of the stool after p-inulin treatment compared with pre-treatment

    Time frame: 24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)

    Bacterial Composition: the relative abundance of bacterial taxa, as determined by 16S rRNA gene sequencing, will be quantified.

  5. Within-cohort variability in the metabolomic profile and targeted metabolites / inflammatory markers during the no treatment phase.

    Time frame: 24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)

    Metabolomic Profile: the relative abundance of metabolites, determined by liquid chromatography-mass spectrometry (LC-MS), will be quantified under each condition and compared between groups.

  6. Within-cohort variability in the bacterial composition during the no treatment phase.

    Time frame: 24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)

    Bacterial Composition: the relative abundance of bacterial taxa, as determined by 16S rRNA gene sequencing, will be quantified under each condition and compared between groups.

  7. Within-cohort variability in the metabolomics profile and targeted metabolites/inflammatory markers during the p-inulin treatment phase.

    Time frame: 24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)

    Metabolomic Profile: the relative abundance of metabolites, determined by liquid chromatography-mass spectrometry (LC-MS), will be quantified under each condition and compared between groups.

  8. Within-cohort variability in the bacterial composition during the p-inulin treatment phase.

    Time frame: 24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)

    Bacterial Composition: the relative abundance of bacterial taxa, as determined by 16S rRNA gene sequencing, will be quantified under each condition and compared between groups.

  9. Within-cohort change in the metabolomic profile and targeted metabolites/inflammatory markers after p-inulin treatment compared with pre-treatment

    Time frame: 24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)

    Metabolomic Profile: the relative abundance of metabolites, determined by liquid chromatography-mass spectrometry (LC-MS), will be quantified under each condition and compared between groups.

  10. Within-cohort change in the bacterial composition after p-inulin treatment compared with pre-treatment.

    Time frame: 24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)

    Bacterial Composition: the relative abundance of bacterial taxa, as determined by 16S rRNA gene sequencing, will be quantified under each condition and compared between groups.

Other outcomes

  1. Change in Score of the Gastrointestinal Symptom Rating Scale (GSRS)

    Time frame: 24 weeks

    Gastrointestinal symptoms as measured by the Gastrointestinal Symptom Rating Scale (GSRS)

  2. Number of Participants Who Discontinue Use of p-inulin

    Time frame: 8 week period of treatment

  3. Number of Participants Who Reduce the Dose of p-inulin

    Time frame: 8 week period of treatment

  4. Number of Adverse Events

    Time frame: 24 weeks

  5. Enrollment Refusal Rate

    Time frame: 2 years

  6. Proportion of completed stool sample collections

    Time frame: 24 weeks

  7. Proportion of completed blood sample collections

    Time frame: 24 weeks

  8. Adherence rate to p-inulin

    Time frame: 8 weeks

    Assessed by sachet counts

  9. Rate of Study Withdrawal

    Time frame: 24 weeks

    Number of subjects who withdrew during each phase

Sponsors and collaborators

Lead sponsor

Ali Ramezani

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 29, 2017
Registry last updated
Nov 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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