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Prebiotics in Peritoneal Dialysis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03265639
Recruitment Status : Completed
First Posted : August 29, 2017
Last Update Posted : November 19, 2018
Sponsor:
Information provided by (Responsible Party):
Ali Ramezani, George Washington University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
End Stage Renal Disease Gut Microbiome Dysbiosis Dietary Supplement: P-inulin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Masking Description: Open label
Primary Purpose: Treatment
Official Title: Prebiotics in Peritoneal Dialysis
Actual Study Start Date : April 21, 2016
Actual Primary Completion Date : February 28, 2018
Actual Study Completion Date : February 28, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis
Drug Information available for: Inulin

Arm Intervention/treatment
No Intervention: Pre-treatment
This arm is the 8-week observation period before the p-inulin treatment phase.
Experimental: Intervention
This arm is the 8 week p-inulin treatment phase (8 grams twice daily, oral).
Dietary Supplement: P-inulin
No Intervention: Post-treatment
This arm is the 8-week observation period after the p-inulin treatment phase.



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03265639


Locations
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United States, District of Columbia
DaVita Georgetown Home Training Unit
Washington, District of Columbia, United States, 20007
DaVita K Street
Washington, District of Columbia, United States, 20037
Sponsors and Collaborators
Ali Ramezani
Investigators
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Principal Investigator: Dominic Raj, MD The George Washington University
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Responsible Party: Ali Ramezani, Assistant Research Professor, George Washington University
ClinicalTrials.gov Identifier: NCT03265639    
Other Study ID Numbers: 091440
First Posted: August 29, 2017    Key Record Dates
Last Update Posted: November 19, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Dysbiosis
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Pathologic Processes