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

Charité University Medicine Berlin

Status: Enrolling

Conditions: Chronic Kidney Disease 5D

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Inulin

Study type: Interventional

Funder types: Other

Identifiers

NCT05071131

RESTORE

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Inulin

Active Comparator group

Description:

15 grams inulin per day for 7 days, followed by 30 grams inulin per day for 28 days

Treatment:

Dietary Supplement: Inulin

Placebo

Placebo Comparator group

Description:

15 grams maltodextrin per day for 7 days, followed by 30 grams maltodextrin per day for 28 days

Treatment:

Dietary Supplement: Placebo