Clinical Trial to Evaluate the Addition to an Antiretroviral Treatment of a Probiotic

NCT03542786 | Completed

• 1 other identifier: I3.1 IRSICAIXA
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this study is to evaluate a therapy for the inflammaging (premature aging).

Conditions

HIV; Premature Aging

Keywords

HIV-1

Outcome Measures

Primary Outcomes (1)

• The appearance of adverse effects.

  Percentage of patients with adverse events (AE) in the 3 study arms: i3.1, i3.1 + ProSeed and Placebo.

  Change from Baseline Adverse Effects will be measured at 1 month and 3 months after the treatment beginning (V1 and V2 respectively).

Secondary Outcomes (7)

• Gut microbiota diversity and metabolomic profile

  A measure will be made in V1, V2, V3 and V4 (1 month, 3 months, 6 months and 9 months after the treatment beginning, respectively).

• Translocational bacterial markers & Systemic inflammation markers

  A measure will be made in V1 and V2 (1 month and 3 months after the treatment beginning, respectively).

• Cluster of Differentation 4 (CD4) count

  A measure will be made in V2, V3 and V4 (3 months, 6 months and 9 months after the treatment beginning, respectively).

• CD4/CD8 ratio

  A measure will be made in V2, V3 and V4 (3 months, 6 months and 9 months after the treatment beginning, respectively).

• Satisfaction with the product

  A measure will be made in V2, V3 and V4 (3 months, 6 months and 9 months after the treatment beginning, respectively).

Study Arms (3)

i3.1

EXPERIMENTAL

This group will have their habitual antiretroviral therapy (integrase inhibitor (INI), protease inhibitor (IP), reverse transcriptase inhibitor (ITINAN)) combined with the research product (probiotic i3.1). The prebiotic will be taken once a day during 6 months.

Dietary Supplement: Probiotic

i3.1 + ProSeed

EXPERIMENTAL

This group will have their habitual antiretroviral therapy combined with the probiotic (i3.1) and the prebiotic (ProSheed). The prebiotic and probiotic will be taken once a day during 6 months.

Dietary Supplement: Probiotic; Dietary Supplement: Prebiotic

Placebo

PLACEBO COMPARATOR

This group will only have their habitual antiretroviral therapy. The placebo will be taken once a day during 6 months.

Dietary Supplement: Placebo

Interventions

Probiotic DIETARY_SUPPLEMENT

The probiotic i3.1 is a commercialized product. It will be supplied by the promoter and manufactured in ALIFARM S.A. It contains: * Lactobacillus plantarum CECT7484 * Lactobacillus plantarum CECT7485 * Pediococcus acidilactici CECT7483

i3.1; i3.1 + ProSeed

Prebiotic DIETARY_SUPPLEMENT

ProSeed prebiotic is a non-commercialized product. It will be supplied by the promoter and manufactured in ALIFARM S.A. It contains: * Partially Hydrolyzed Guar Gum (PHGG) * Inulin HPD * Oat Beta-Glucans * Pectin * Inulin Low Protein Diet (LPD) * Polydextrose * Maltrodextrins

i3.1 + ProSeed

Placebo DIETARY_SUPPLEMENT

It is a non-commercialized product. It is composed of the same excipients as the probiotic and the prebiotic. It will be supplied by the promoter and manufactured in ALIFARM S.A.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Older than 18 years old.
• Documented HIV-1 infection.
• Be in treatment with these antiretrovirals (INI, IP, ITINAN) during 12 months.
• HIV-1 Viral titer \<50 copies/mL during 6 months.
• CD4\> 500 cells/mm3.

You may not qualify if:

• Treatment with antibiotics.
• Severe diseases actives.
• Defining diseases of AIDS in the previous year.
• Gut surgery except appendectomy or cholecystectomy.
• Pregnancy.
• Any diet deviation (vegans).
• Other probiotic treatment.

Sponsors & Collaborators

• AB Biotics, SA: lead
• Germans Trias i Pujol Hospital: collaborator

Study Sites (1)

Hospital Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Related Publications (1)

• Blazquez-Bondia C, Parera M, Catala-Moll F, Casadella M, Elizalde-Torrent A, Aguilo M, Espadaler-Mazo J, Santos JR, Paredes R, Noguera-Julian M. Probiotic effects on immunity and microbiome in HIV-1 discordant patients. Front Immunol. 2022 Dec 8;13:1066036. doi: 10.3389/fimmu.2022.1066036. eCollection 2022.

  PMID: 36569851 DERIVED

MeSH Terms

Conditions

Aging, Premature

Interventions

Probiotics; Prebiotics

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Dietary Fiber; Dietary Carbohydrates; Carbohydrates; Polysaccharides, Bacterial; Polysaccharides

Study Officials

• Ariana Salavert, PhD

  AB-Biotics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 100 patients will be included in this trial. Patients will be randomized 2: 2: 1 to one of the following 3 branches according to the use of integrase inhibitors (INI), protease inhibitors (PI) or non-nucleoside analogue reverse transcriptase inhibitors ( ITINAN) and according to the CD4 count nadir is greater or less or equal to 200 cells / mm3: Branch A: add probiotic i3.1 to the antiretroviral therapy Branch B: add probiotic i3.1 and ProSeed prebiotic to the antiretroviral therapy Branch C: add placebo to ART The treatment periods will be of 6 months and follow-up will be carried out at month, at 3 months and at 6 after the start of the study treatment, and a last visit will be made at 3 months after discontinuing it (wash-out period).

Study Record Dates

• First Submitted: May 8, 2018
• First Posted: May 31, 2018
• Study Start: December 18, 2017
• Primary Completion: February 29, 2020
• Study Completion: February 29, 2020
• Last Updated: July 8, 2020

Record last verified: 2020-07

Locations

ES (1)