Effect of Inulin on Gut Microbiota and Gut Barrier in Chronic Kidney Disease (RESTORE)

June 24, 2024 updated by: Till Schütte, Charite University, Berlin, Germany

Investigating the Effect of Inulin on Gut Microbiota and Gut Barrier in Advanced Chronic Kidney Disease - a Randomised, Placebo-controlled Trial

An adequate fiber intake is crucial for a well-balanced diet and reduces the risk of chronic diseases. However, nutritional recommendations for chronic kidney disease patients lead to an insufficient fiber intake with possible maladaptive effects on the gut microbiome. Therefore, we want to study the effects of a 35-day inulin supplementation on the gut microbiome, gut barrier function, bacterial metabolites and immune cell states in chronic kidney disease patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Men and women in a ratio of 1:1
  • Age 18-75 years
  • Body mass index 25.0 - 39.9 kg/m^2
  • End-stage kidney disease, which has been treated regularly with hemodialysis for at least 3 months

Exclusion Criteria:

  • Malignant diseases
  • Recent or current hospitalization
  • Postoperative phase
  • Acute infections
  • Malnutrition
  • Antibiotic treatment within the last 4 weeks
  • Regular intake of probiotics and/or prebiotics
  • Change of body weight of more than 2 kg in the month prior to study entry
  • Known drug or alcohol abuse

Changes applied in July 2022 according to amendment no. 1:

  • Two inclusion criteria were changed to improve recruitment

    • Age range was changed from 18-70 to 18-75 years
    • BMI range was changed from 18.5 - 34.9 to 25.0 - 39.9 kg/m^2

  • The intervention scheme was adapted to increase patient adherence

    • A 7-day adaption phase with half of the dose (15 grams per day) at the start of the intervention was introduced, changing treatment duration from 28 to 35 days

Changes applied in January 2024 according to amendment no. 2:

  • One inclusion criteria was changed to improve recruitment

    • BMI range was changed from 25 - 39,9 to 18,5 - 39,9 kg/m²
  • Last visit was brought foward by 4 weeks.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Inulin
15 grams inulin per day for 7 days, followed by 30 grams inulin per day for 28 days
Dietary supplement: Inulin
1 sachet à 15 grams daily for 7 days, followed by 2 sachets à 15 grams daily for 28 days
Placebo Comparator: Placebo
15 grams maltodextrin per day for 7 days, followed by 30 grams maltodextrin per day for 28 days
Dietary supplement: Placebo
1 sachet à 15 grams daily for 7 days, followed by 2 sachets à 15 grams daily for 28 days

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Plasma concentration of Zonulin-1
Time Frame: After 35 days compared to placebo
Measured by ELISA [ng/ml]
After 35 days compared to placebo

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Plasma concentration of soluble CD14
Time Frame: After 35 days compared to placebo
Measured by ELISA [ng/ml]
After 35 days compared to placebo
Short-chain fatty acid-associated bacterial gene expression
Time Frame: After 35 days compared to placebo and adjusted for baseline
Measured by quantitative PCR
After 35 days compared to placebo and adjusted for baseline
Short-chain fatty acid-associated gene expression in immune cells
Time Frame: After 35 days compared to placebo
Measured by quantitative PCR
After 35 days compared to placebo
Indole-associated bacterial gene expression
Time Frame: After 35 days compared to placebo
Measured by quantitative PCR
After 35 days compared to placebo
Indole-associated gene expression in immune cells
Time Frame: After 35 days compared to placebo
Measured by quantitative PCR
After 35 days compared to placebo
Fecal metabolome
Time Frame: After 35 days compared to placebo and adjusted for baseline
Measured by mass spectrometry
After 35 days compared to placebo and adjusted for baseline
Serum metabolome
Time Frame: After 35 days compared to placebo
Measured by mass spectrometry
After 35 days compared to placebo
Serum concentration of Trimethylamine-N-Oxide (TMAO)
Time Frame: After 35 days compared to placebo
Measured by LC-MS [µM]
After 35 days compared to placebo
Fecal microbiome taxonomy
Time Frame: After 35 days compared to placebo
Measured by 16S amplicon sequencing
After 35 days compared to placebo
Activation potential of aryl hydrocarbon receptor (AhR) in serum
Time Frame: After 35 days compared to placebo and adjusted for baseline
Measured by cell-based luciferase reporter assay (delta luminescence)
After 35 days compared to placebo and adjusted for baseline
Frequency of circulating T-cell subtypes
Time Frame: After 35 days compared to placebo
Measured by flow cytometry (%)
After 35 days compared to placebo
Office systolic blood pressure
Time Frame: After 35 days compared to placebo
Mean of five consecutive blood pressure measurements (mmHg)
After 35 days compared to placebo
Office diastolic blood pressure
Time Frame: After 35 days compared to placebo
Mean of five consecutive blood pressure measurements (mmHg)
After 35 days compared to placebo
Plasma concentration of IL-1
Time Frame: After 35 days compared to placebo
Measured by ELISA [pg/ml]
After 35 days compared to placebo
Plasma concentration of IL-6
Time Frame: After 35 days compared to placebo
Measured by ELISA [pg/ml]
After 35 days compared to placebo
Plasma concentration of TNF-alpha
Time Frame: After 35 days compared to placebo
Measured by ELISA [pg/ml]
After 35 days compared to placebo
Creatinine
Time Frame: After 35 days compared to placebo
Creatine serum concentration
After 35 days compared to placebo
Cystatin c
Time Frame: After 35 days compared to placebo
Cystatin c serum concentration
After 35 days compared to placebo
Creatinine / cystatin c ratio
Time Frame: After 35 days compared to placebo
Measured in serum
After 35 days compared to placebo

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Charite University, Berlin, Germany

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Anja Mähler, PhD, Charite University, Berlin, Germany
  • Principal Investigator: Nicola Wilck, MD, Charite University, Berlin, Germany
  • Principal Investigator: Victoria McParland, PhD, Charite University, Berlin, Germany
  • Principal Investigator: Johannes Holle, MD, Charite University, Berlin, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 16, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 8, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 25, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RESTORE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie the results of reported articles (text, tables, figures, supplemental data) will be shared after deidentification.

IPD Sharing Time Frame

Beginning 9 months and ending 36 months following article publication.

IPD Sharing Access Criteria

Researchers who provide a methodologically sound proposal.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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