NCT02276326

Brief Summary

Aim of the study is to evaluate the effects of a change in the intestinal microflora on the neuro-cognitive profile of patients with HIV infection receiving HAART treatment. Improvements will be evaluated with questionnaires on Quality of life and Cognitive and Behavior function. 20 patients will be enrolled and will receive 4 sachets of VSL#3 per day.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 17, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 28, 2014

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

4.4 years

First QC Date

October 17, 2014

Last Update Submit

February 4, 2023

Conditions

HIV SeropositivityART

Outcome Measures

Primary Outcomes (3)

  • Delta of scores of questionnaires on quality of life

    HIV dementia-scale, Beck Depression Inventory BDI-II, State Trait Anxiety Inventory (STAI Y 1 - Y2), the questionnaire for the assessment of quality of life in persons with HIV infection (ISS-QoL)

    4 months

  • Delta of scores of questionnaires on cognitive functions

    HIV dementia-scale, Beck Depression Inventory BDI-II, State Trait Anxiety Inventory (STAI Y 1 - Y2), the questionnaire for the assessment of quality of life in persons with HIV infection (ISS-QoL)

    4 months

  • Delta of scores of questionnaires on behavioral functions

    HIV dementia-scale, Beck Depression Inventory BDI-II, State Trait Anxiety Inventory (STAI Y 1 - Y2), the questionnaire for the assessment of quality of life in persons with HIV infection (ISS-QoL)

    4 months

Secondary Outcomes (1)

  • Delta of value of serum lipopolysaccharide (LPS)

    between time 0 and after 4 months of assumption of VSL#3

Other Outcomes (7)

  • Delta of Cluster of Differentiation 14 (CD14)+ in blood (T0-T1)

    between time 0 and after 4 months of assumption

  • Delta of value of serum lipopolysaccharide binding protein (LBP)

    between time 0 and after 4 months of assumption

  • Delta of value of serum EndoCAb

    between time 0 and after 4 months of assumption

  • +4 more other outcomes

Study Arms (1)

VSL#3 sachets

EXPERIMENTAL

VSL#3 is a mix of lactic acid bacteria and bifidobacteria (original De Simone's formulation)

Dietary Supplement: VSL#3 sachets

Interventions

VSL#3 sachetsDIETARY_SUPPLEMENT

4 sachets a day for 4 months

VSL#3 sachets

Eligibility Criteria

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

You may qualify if:

  • Men or women at least 18 years of age
  • In HAART with HIV RNA \<50cp/mL, with CD4 counts\> 400 cells / mm
  • Availability to release informed consent

You may not qualify if:

  • Patients with known allergy or intolerance to VSL#3
  • Chronic inflammatory bowel diseases
  • Drug addiction
  • Use of antibiotics or probiotics during the 3 weeks prior the enrollment
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Policlinico Umberto I Hospital

Rome, 00155, Italy

Location

Related Publications (3)

  • Ceccarelli G, Brenchley JM, Cavallari EN, Scheri GC, Fratino M, Pinacchio C, Schietroma I, Fard SN, Scagnolari C, Mezzaroma I, Vullo V, d'Ettorre G. Impact of High-Dose Multi-Strain Probiotic Supplementation on Neurocognitive Performance and Central Nervous System Immune Activation of HIV-1 Infected Individuals. Nutrients. 2017 Nov 21;9(11):1269. doi: 10.3390/nu9111269.

    PMID: 29160817RESULT

  • Ceccarelli G, Fratino M, Selvaggi C, Giustini N, Serafino S, Schietroma I, Corano Scheri G, Pavone P, Passavanti G, Alunni Fegatelli D, Mezzaroma I, Antonelli G, Vullo V, Scagnolari C, d'Ettorre G. A pilot study on the effects of probiotic supplementation on neuropsychological performance and microRNA-29a-c levels in antiretroviral-treated HIV-1-infected patients. Brain Behav. 2017 Jul 16;7(8):e00756. doi: 10.1002/brb3.756. eCollection 2017 Aug.

    PMID: 28828217RESULT

  • Santinelli L, Ceccarelli G, Borrazzo C, Innocenti GP, Frasca F, Cavallari EN, Celani L, Nonne C, Mastroianni CM, d'Ettorre G. Sex-related differences in markers of immune activation in virologically suppressed HIV-infected patients. Biol Sex Differ. 2020 May 1;11(1):23. doi: 10.1186/s13293-020-00302-x.

    PMID: 32357901DERIVED

MeSH Terms

Conditions

HIV Seropositivity

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Gabriella D'Ettorre

    Policlinico Umberto I Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

October 17, 2014

First Posted

October 28, 2014

Study Start

July 1, 2014

Primary Completion

December 1, 2018

Study Completion

June 1, 2019

Last Updated

February 8, 2023

Record last verified: 2023-02

Locations

IT(1)