---
title: Effect of Inulin on Gut Microbiota and Gut Barrier in Chronic Kidney Disease
nct_id: NCT05071131
overall_status: RECRUITING
phase: NA
sponsor: Charite University, Berlin, Germany
study_type: INTERVENTIONAL
primary_condition: Chronic Kidney Disease 5D
countries: Germany
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05071131.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05071131"
ct_last_update_post_date: 2024-06-25
last_seen_at: "2026-05-12T07:10:40.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Effect of Inulin on Gut Microbiota and Gut Barrier in Chronic Kidney Disease

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

**NCT ID:** [NCT05071131](https://clinicaltrials.gov/study/NCT05071131)

## Key Facts

- **Status:** RECRUITING
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 40
- **Lead Sponsor:** Charite University, Berlin, Germany
- **Conditions:** Chronic Kidney Disease 5D
- **Start Date:** 2022-02-01
- **Completion Date:** 2027-02-01
- **CT.gov Last Update:** 2024-06-25

## Brief Summary

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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 75 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **Inulin** (ACTIVE_COMPARATOR) — 15 grams inulin per day for 7 days, followed by 30 grams inulin per day for 28 days
- **Placebo** (PLACEBO_COMPARATOR) — 15 grams maltodextrin per day for 7 days, followed by 30 grams maltodextrin per day for 28 days

## Interventions

- **Inulin** (DIETARY_SUPPLEMENT) — 1 sachet à 15 grams daily for 7 days, followed by 2 sachets à 15 grams daily for 28 days
- **Placebo** (DIETARY_SUPPLEMENT) — 1 sachet à 15 grams daily for 7 days, followed by 2 sachets à 15 grams daily for 28 days

## Primary Outcomes

- **Plasma concentration of Zonulin-1** _(time frame: After 35 days compared to placebo)_ — Measured by ELISA \[ng/ml\]

## Secondary Outcomes

- **Plasma concentration of soluble CD14** _(time frame: 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)_
- **Short-chain fatty acid-associated gene expression in immune cells** _(time frame: After 35 days compared to placebo)_
- **Indole-associated bacterial gene expression** _(time frame: After 35 days compared to placebo)_
- **Indole-associated gene expression in immune cells** _(time frame: After 35 days compared to placebo)_
- **Fecal metabolome** _(time frame: After 35 days compared to placebo and adjusted for baseline)_
- **Serum metabolome** _(time frame: After 35 days compared to placebo)_
- **Serum concentration of Trimethylamine-N-Oxide (TMAO)** _(time frame: After 35 days compared to placebo)_
- **Fecal microbiome taxonomy** _(time frame: 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)_
- **Frequency of circulating T-cell subtypes** _(time frame: After 35 days compared to placebo)_
- **Office systolic blood pressure** _(time frame: After 35 days compared to placebo)_
- **Office diastolic blood pressure** _(time frame: After 35 days compared to placebo)_
- **Plasma concentration of IL-1** _(time frame: After 35 days compared to placebo)_
- **Plasma concentration of IL-6** _(time frame: After 35 days compared to placebo)_
- **Plasma concentration of TNF-alpha** _(time frame: After 35 days compared to placebo)_
- **Creatinine** _(time frame: After 35 days compared to placebo)_
- **Cystatin c** _(time frame: After 35 days compared to placebo)_
- **Creatinine / cystatin c ratio** _(time frame: After 35 days compared to placebo)_

## Locations (1)

- Experimental and Clinical Research Center, Berlin, Germany — _RECRUITING_

## Recent Field Changes (last 30 days)

- `eligibility.sex` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.experimental and clinical research center|berlin||germany` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT05071131.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT05071131*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*