Effect of Probiotic Consumption on Chronic Kidney Disease

NCT03400228 | Completed DMC

• 1 other identifier: 072015
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Recent studies have demonstrated that the balance of intestinal microbiota is affected in chronic kidney disease (CKD), leading to a condition known as intestinal dysbiosis. These changes were associated with metabolic complications, accumulation of uremic toxins, inflammation, progression of CKD and cardiovascular risk. Measures with the aim of restore the balance of intestinal flora are suggested, such as the intake of probiotics composed of beneficial bacteria, but few studies have discussed the effect of these supplements in CKD. The present study aims to evaluate the effect of consumption of probiotics in factors associates with progression of CKD and cardiovascular risk. To such will be conducted a double-blind, placebo-controlled, and randomized clinical trial with 30 patients with CKD in stages 3-5, treated in ambulatories of Nephrology of the Hospital de Clínicas de Porto Alegre, independently of etiology and with steady renal function. Patients will be excluded whether in substitutive renal therapy, kidney transplant, on antimicrobial therapy or immunosuppressive agents in the last three months or with acute clinical events. The assessment will include clinical and nutritional parameters, estimated glomerular filtration rate, proteinuria, serum lipids, inflammatory factors, and bowel habits. The study protocol includes the recruitment of patients who will undergo to 4-week washout period. After patients will be randomized and provided with probiotic therapy (intervention group) or placebo (maltodextrin; control group) for 24 weeks. All patients will be instructed to consume 2 sachets/day of probiotic or placebo and receive nutritional advice. All data will be analysed by the principal investigator with the support of a trained statistician and the chief investigator. The statistical programme SPSS will be used.

Conditions

Chronic Kidney Disease

Keywords

Probiotics; Chronic kidney disease; Cardiovascular risk

Outcome Measures

Primary Outcomes (1)

• Decrease in serum creatinine level

  Reduction of serum creatinine level

  24 weeks

Secondary Outcomes (1)

• Reduced levels of serum lipids

  24 weeks

Study Arms (2)

Protics

EXPERIMENTAL

Patients in the intervention group were to drink 2 sachets of 1g of probiotic daily for 24 weeks

Dietary Supplement: Probiotic

Placebo

PLACEBO COMPARATOR

Patients in the intervention group were to drink 2 sachets of 1g of maltodextrin daily for 24 weeks

Dietary Supplement: Maltodextrin

Interventions

Probiotic DIETARY_SUPPLEMENT

The probiotic is composed of a combination of Lactobacillus acidophilus (LA-5®) and Bifidobacterium lactis (BB-12®).

Protics

Maltodextrin DIETARY_SUPPLEMENT

Maltodextrin is a supplement feed based carbohydrate powder and tasteless.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with chronic kidney disease stage 3, 4 and 5;
• Stable renal function;
• Proteinuria greater than or equal to 500 mg;
• Patients who agree to participate.

You may not qualify if:

• Patients on renal replacement therapy or kidney transplant;
• Patients with prior renal transplant;
• Patients with acute clinical events;
• Patients using antibiotics or any other medications that can alter the intestinal microbiota as corticosteroids and immunosuppressants in the last three months;
• Patients with active infection;
• Patients with inflammatory bowel diseases or malabsorption;
• Acute or chronic diarrhea;
• Patients with previous intestinal surgery;
• Pregnants.

Sponsors & Collaborators

• Centro Universitário Univates: lead

Study Sites (1)

Thaís Rodrigues Moreira

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Probiotics; maltodextrin

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Thais Rodrigues, Moreira

  university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 8, 2018
• First Posted: January 17, 2018
• Study Start: July 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: December 31, 2017
• Last Updated: January 17, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)