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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCharite University, Berlin, Germany

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Men and women in a ratio of 1:1

Age 18-75 years

Body mass index 25.0 - 39.9 kg/m²

End-stage kidney disease, which has been treated regularly with hemodialysis for at least 3 months

Disqualifiers

Malignant diseases

Recent or current hospitalization

Postoperative phase

Acute infections

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: InulinActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Plasma concentration of Zonulin-1

Measured by ELISA \[ng/ml\]

Time frame
After 35 days compared to placebo

Secondary outcomes

1

Plasma concentration of soluble CD14

Measured by ELISA \[ng/ml\]

Time frame
After 35 days compared to placebo
2

Short-chain fatty acid-associated bacterial gene expression

Measured by quantitative PCR

Time frame
After 35 days compared to placebo and adjusted for baseline
3

Short-chain fatty acid-associated gene expression in immune cells

Measured by quantitative PCR

Time frame
After 35 days compared to placebo
4

Indole-associated bacterial gene expression

Measured by quantitative PCR

Time frame
After 35 days compared to placebo

Other outcomes

Sponsors and contacts

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