End Stage Renal DiseaseNCT03265639
Prebiotics in Peritoneal Dialysis
A study testing P-inulin in people with End Stage Renal Disease and Gut Microbiome Dysbiosis, run by Ali Ramezani at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- End Stage Renal Disease, Gut Microbiome Dysbiosis
- What is being tested?
- P-inulin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Apr 2016to 28 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Peritoneal dialysis therapy for end-stage renal disease
- ≥30 days since dialysis initiation
- Ability to provide informed consent
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
DaVita Georgetown Home Training Unit
Washington D.C., District of Columbia, 20007
DaVita K Street
Washington D.C., District of Columbia, 20037
About this study
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.
- Conditions
- End Stage Renal Disease, Gut Microbiome Dysbiosis
- Being tested
- P-inulin
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P-inulinDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Pre-treatment | No intervention | This arm is the 8-week observation period before the p-inulin treatment phase. |
| Intervention | Experimental | This arm is the 8 week p-inulin treatment phase (8 grams twice daily, oral). Receives: Dietary Supplement: P-inulin |
| Post-treatment | No intervention | This arm is the 8-week observation period after the p-inulin treatment phase. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change within-patient in the metabolomic profile and targeted metabolites / inflammatory markers during the no treatment phases and the p-inulin treatment phase.
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.
Measured: 24 weeks
Secondary outcomes (10)
Within-patient change in the metabolomic profile and targeted metabolites / inflammatory markers after p-inulin treatment compared with pre-treatment.
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.
Measured: 24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)
Within-patient variability in the bacterial composition of the stool during the no treatment phase.
Bacterial Composition: the relative abundance of bacterial taxa, as determined by 16S rRNA gene sequencing, will be quantified.
Measured: 24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)
Within-patient variability in the bacterial composition of the stool during the p-inulin treatment phase.
Bacterial Composition: the relative abundance of bacterial taxa, as determined by 16S rRNA gene sequencing, will be quantified.
Measured: 24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)
Within-patient change in the bacterial composition of the stool after p-inulin treatment compared with pre-treatment
Bacterial Composition: the relative abundance of bacterial taxa, as determined by 16S rRNA gene sequencing, will be quantified.
Measured: 24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)
Within-cohort variability in the metabolomic profile and targeted metabolites / inflammatory markers during the no treatment phase.
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.
Measured: 24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)
Within-cohort variability in the bacterial composition during the no treatment phase.
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.
Measured: 24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)
Within-cohort variability in the metabolomics profile and targeted metabolites/inflammatory markers during the p-inulin treatment phase.
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.
Measured: 24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)
Within-cohort variability in the bacterial composition during the p-inulin treatment phase.
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.
Measured: 24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)
Within-cohort change in the metabolomic profile and targeted metabolites/inflammatory markers after p-inulin treatment compared with pre-treatment
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.
Measured: 24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)
Within-cohort change in the bacterial composition after p-inulin treatment compared with pre-treatment.
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.
Measured: 24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study start21 Apr 2016
- Primary completion28 Feb 2018
- Study completion28 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ali Ramezani
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ali Ramezani, George Washington University
- Investigators
- Dominic Raj, MD, Principal investigator, The George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03265639
- Sponsor's protocol ID
- 091440
- Status last verified
- Nov 2018
- First submitted
- 17 Feb 2017
- Last updated
- 19 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prebiotics in Peritoneal Dialysis
- ClinicalTrials.gov ID
- NCT03265639
- Acronym / sponsor ID
- 091440
- Conditions
- End Stage Renal Disease, Gut Microbiome Dysbiosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Ali RamezaniUniversity, hospital or other
- Study start
- 21 Apr 2016 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 29 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pre-treatment | No intervention | –This arm is the 8-week observation period before the p-inulin treatment phase. |
| Intervention | Experimental | Dietary Supplement: P-inulinThis arm is the 8 week p-inulin treatment phase (8 grams twice daily, oral). |
| Post-treatment | No intervention | –This arm is the 8-week observation period after the p-inulin treatment phase. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Peritoneal dialysis therapy for end-stage renal disease
- ≥30 days since dialysis initiation
- Ability to provide informed consent
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| P-inulin | Dietary supplement | Intervention |
Primary outcome
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.
10 secondary outcomes
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dominic Raj, MD principal investigator
The George Washington University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing P-inulin in people with End Stage Renal Disease and Gut Microbiome Dysbiosis, run by Ali Ramezani at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2018; AzTrials last refreshed its copy on 28 Oct 2026.