NCT02179229

Brief Summary

The purpose of this study is to establish whether a short treatment with the synbiotic combination Probinul neutro® may decrease the plasma concentration of the uremic toxin p-cresol in patients bearing a kidney allograft. The effect of this treatment on plasma levels of immunosuppressant drugs will be evaluated as well.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

June 27, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 1, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

July 2, 2014

Status Verified

June 1, 2014

Enrollment Period

1 year

First QC Date

June 27, 2014

Last Update Submit

July 1, 2014

Conditions

Renal Insufficiency, Chronic

Keywords

Kidney transplantationpCresolImmunosuppressant drugs

Outcome Measures

Primary Outcomes (1)

  • Change in p-cresol plasma concentration

    Total p-cresol (free and glucurono- or sulpho-conjugates) plasma concentration will be assessed by reverse phase HPLC at baseline, 15 and 30 days after starting synbiotic treatment.

    one month

Secondary Outcomes (2)

  • Change in bowel habits

    one month

  • Change in plasma immunosuppressant drug concentration

    one month

Study Arms (2)

CONTROL

PLACEBO COMPARATOR

Patient in the CONTROL arm will receive a powder containing only tapioca-resistant starch comparable in colour, texture and taste to the synbiotic.

Dietary Supplement: CONTROL

SYNBIOTIC

EXPERIMENTAL

Patients in this group will receive Probinul neutro® a synbiotic preparation containing (perpacket): lyophilised bacteria (5×109 Lactobacillus plantarum, 2×109 Lactobacillus casei subsp. rhamnosus and 2×109 Lactobacillus gasseri, 1×109 Bifidobacterium infantis and 1×109 Bifidobacterium longum, 1×109 Lactobacillus acidophilus, 1×109 Lactobacillus salivarius and 1×109 Lactobacillus sporogenes and 5×109 Streptococcus thermophilus), prebiotic inulin (2.2 g; VB Beneo Synergy 1) and 1.3 g of tapioca-resistant starch.

Dietary Supplement: SYNBIOTIC

Interventions

CONTROLDIETARY_SUPPLEMENT

Placebo will be taken at home for four weeks as 5 g powder packets to be dissolved in water three times a day far from meals.

Also known as: PLACEBO
CONTROL
SYNBIOTICDIETARY_SUPPLEMENT

Probinul Neutro® will be taken at home for four weeks as 5 g powder packets to be dissolved in water three times a day far from meals.

Also known as: Probinul Neutro®
SYNBIOTIC

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Previous renal allograft transplantation

You may not qualify if:

  • severe infections
  • diabetes
  • malignancy
  • history of food intolerance
  • autoimmune disorders
  • severe malnutrition or clinical conditions requiring artificial feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nutrition Unit of the Federico II University of Naples

Naples, 80131, Italy

RECRUITING

Related Publications (1)

  • Cooper TE, Scholes-Robertson N, Craig JC, Hawley CM, Howell M, Johnson DW, Teixeira-Pinto A, Jaure A, Wong G. Synbiotics, prebiotics and probiotics for solid organ transplant recipients. Cochrane Database Syst Rev. 2022 Sep 20;9(9):CD014804. doi: 10.1002/14651858.CD014804.pub2.

    PMID: 36126902DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Synbiotics

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PrebioticsDietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaProbioticsFood and Beverages

Study Officials

  • Bruna Guida, MD

    Federico II University of Naples

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

June 27, 2014

First Posted

July 1, 2014

Study Start

June 1, 2014

Primary Completion

June 1, 2015

Study Completion

August 1, 2015

Last Updated

July 2, 2014

Record last verified: 2014-06

Locations

IT(1)