HIVRECOVERNCT03542786
Clinical Trial to Evaluate the Addition to an Antiretroviral Treatment of a Probiotic
A study testing Probiotic and Prebiotic in people with HIV and Premature Aging, run by AB Biotics, SA at 1 site in Spain.
Trial summary
The main purpose of this study is to evaluate a therapy for the inflammaging (premature aging). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV, Premature Aging
- What is being tested?
- Probiotic and Prebiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 89 participants
- Where
- 1 siteSpain
- Study dates
- 18 Dec 2017to 29 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Trial, Randomized and Controlled With Placebo to Evaluate the Addition to an Antiretroviral Treatment of a Probiotic, Only or in Conjunction of a Pre-biotical, in Adults Infected by Hiv-1 With a cd4 Record Less Than 500 Cells / mm3
The main purpose of this study is to evaluate a therapy for the inflammaging (premature aging).
Read the detailed description
It's been demonstrated that the HIV-1 virus is associated to the reduction of the microbiota. Some studies suggest that because of this bacterial reduction, the premature aging appears. So this study aims to demonstrate that our probiotic can balance the microbiota as a preventive solution for the inflammaging.
- Conditions
- HIV, Premature Aging
- Being tested
- Probiotic, Prebiotic, Placebo
- Keywords
- HIV-1
- Medical subject headings
- Aging, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary 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
PrebioticDietary 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
PlaceboDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The appearance of adverse effects.
Percentage of patients with adverse events (AE) in the 3 study arms: i3.1, i3.1 + ProSeed and Placebo.
Measured: 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
Biodiversity changes among the basal visit and 3 months after (in each arm), measured using the Shannon Index.
Measured: 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
Markers changes among the basal visit and 3 months after, in each arm.The plasma levels of lipopolysaccharide, sCD14, Interleukin 6 and Iinterleukin 10 will be measured.
Measured: 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
Recount changes (cells/mm3) among the basal visit and 3 months after, in each arm.
Measured: 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
Ratio changes among the basal visit and 3 months after, in each arm.
Measured: 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
This parameter will be measured in order to evaluate the satisfaction of the patient with the research product. The satisfaction with the product wil be measured with the Likert Scale (with answers from satisfied to unsatisfied).
Measured: A measure will be made in V2, V3 and V4 (3 months, 6 months and 9 months after the treatment beginning, respectively).
Questionaire to evaluate the life quality
This parameter will be measured with the Medical Outcomes Study-HIV questionaire (with answers from not affected to affected).
Measured: A measure will be made in V2, V3 and V4 (3 months, 6 months and 9 months after the treatment beginning, respectively).
Questionaires to evaluate the anxiety and depression
This parameter will be measured with the Hospital Anxiety Depression Scale (HADS) questionaire (with answers from never to always).
Measured: A measure will be made in V2, V3 and V4 (3 months, 6 months and 9 months after the treatment beginning, respectively).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2018
- Study start18 Dec 2017
- Primary completion29 Feb 2020
- Study completion29 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- AB Biotics, SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Germans Trias i Pujol Hospital
- Responsible party
- Sponsor
- Investigators
- Ariana Salavert, PhD, Study director, AB-Biotics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03542786
- Sponsor's protocol ID
- I3.1 IRSICAIXA
- Acronym
- RECOVER
- Status last verified
- Jul 2020
- First submitted
- 8 May 2018
- Last updated
- 8 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36569851
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial, Randomized and Controlled With Placebo to Evaluate the Addition to an Antiretroviral Treatment of a Probiotic, Only or in Conjunction of a Pre-biotical, in Adults Infected by Hiv-1 With a cd4 Record Less Than 500 Cells / mm3
- ClinicalTrials.gov ID
- NCT03542786
- Acronym / sponsor ID
- RECOVER / I3.1 IRSICAIXA
- Conditions
- HIV, Premature Aging
- Keywords
- HIV-1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- AB Biotics, SAIndustry (pharma, biotech, devices)
- Collaborators
- Germans Trias i Pujol Hospital
- Study start
- 18 Dec 2017 (actual)
- Primary completion
- 29 Feb 2020 (actual)
- Study completion
- 29 Feb 2020 (actual)
- First posted
- 31 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to evaluate a therapy for the inflammaging (premature aging).
Detailed description
It's been demonstrated that the HIV-1 virus is associated to the reduction of the microbiota. Some studies suggest that because of this bacterial reduction, the premature aging appears. So this study aims to demonstrate that our probiotic can balance the microbiota as a preventive solution for the inflammaging.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| i3.1 | Experimental | Dietary Supplement: ProbioticThis 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. |
| i3.1 + ProSeed | Experimental | Dietary Supplement: Probiotic, Dietary Supplement: PrebioticThis 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. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboThis group will only have their habitual antiretroviral therapy. The placebo will be taken once a day during 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- Treatment with antibiotics.
- Severe diseases actives.
- Defining diseases of AIDS in the previous year.
- Gut surgery except appendectomy or cholecystectomy.
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbioticThe 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 | Dietary supplement | i3.1, i3.1 + ProSeed |
| PrebioticProSeed 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 | Dietary supplement | i3.1 + ProSeed |
| PlaceboIt 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. | Dietary supplement | Placebo |
Primary outcome
The appearance of adverse effects.
Time frame: Change from Baseline Adverse Effects will be measured at 1 month and 3 months after the treatment beginning (V1 and V2 respectively).
Percentage of patients with adverse events (AE) in the 3 study arms: i3.1, i3.1 + ProSeed and Placebo.
7 secondary outcomes
Gut microbiota diversity and metabolomic profile
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: A measure will be made in V2, V3 and V4 (3 months, 6 months and 9 months after the treatment beginning, respectively).
Questionaire to evaluate the life quality
Time frame: A measure will be made in V2, V3 and V4 (3 months, 6 months and 9 months after the treatment beginning, respectively).
Questionaires to evaluate the anxiety and depression
Time frame: A measure will be made in V2, V3 and V4 (3 months, 6 months and 9 months after the treatment beginning, respectively).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2020.
- Derived from this study: PubMed 36569851Blazquez-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ariana Salavert, PhD study director
AB-Biotics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic and Prebiotic in people with HIV and Premature Aging, run by AB Biotics, SA at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The appearance of adverse effects. (time frame: Change from Baseline Adverse Effects will be measured at 1 month and 3 months after the treatment beginning (V1 and V2 respectively).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03542786, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2020.