HIVPhase 2NCT02146027
Once a Day Use of Lactobacillus Casei Shirota on HIV-infected Patients Infected Patients
A Phase 2 study testing Fermented Milk Drink Yakult 40 in people with HIV, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
In this study, HIV-infected patients with poor recovery of CD4+ T cells and successful viral control after treatment with antiretroviral therapy will be enrolled to receive once a day Lactobcillus casei Shirota or placebo in a double-blind, randomized fashion. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- HIV
- What is being tested?
- Fermented Milk Drink Yakult 40
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2015to Dec 2016
- Phase
- Phase 2
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female HIV-1 infected patients aged between 18 and 60 years.
- Patient on suppressive antiretroviral treatment with poor CD4+ T-cell recovery.
- No change in antiretroviral therapy in the last six months or intended change in the next 12 weeks.
- Availability for the study procedures during the study period.
- Giving informed consent to participate in the study
Who cannot join
- Diagnosis of any concomitant infections or diseases that might affect immunity or natural history of HIV-1 infection including active Hepatitis B infection, Hepatitis C infection, diabetes mellitus, neoplasias and autoimmune diseases.
- Use of treatments that might affect immunity in the last four weeks including immunomodulators, corticosteroids (only systemic use for two weeks or more), or antineoplasic agents.
- History of intolerance or allergy to cow milk or any other component of the study product including lactose intolerance, casein allergy, etc.
- Pregnancy, nursing mother or intention of became pregnant during the study period (only female participants).
- Unable to safely store the study product at home in the conditions recommended by the manufacturer.
- Any other condition that might interfere with the study procedure according to the investigators.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immunological Effects of Continuous, Once a Day Use of Lactobacillus Casei Shirota on HIV-infected Patients on Suppressive Antiretroviral Treatment With Poor CD4+ T-cell Recovery
In this study, HIV-infected patients with poor recovery of CD4+ T cells and successful viral control after treatment with antiretroviral therapy will be enrolled to receive once a day Lactobcillus casei Shirota or placebo in a double-blind, randomized fashion. Immune parameters will be monitored for 12 weeks in both arms.
The main outcome is CD4+ T cell recovery. Secondary outcomes will include NK cells and T cells immune parameters.
Read the detailed description
In this study, HIV-infected patients with poor recovery of CD4+ T cells and successful viral control after treatment with antiretroviral therapy will be enrolled to receive once a day Lactobcillus casei Shirota or placebo in a double-blind, randomized fashion.
The main objective is to investigate whether the continuous, once a day, 12-weeks use of Yakult product containing Lactobacillus casei Shirota could affect immunological parameters in HIV-infected patients on suppressive antiretroviral treatment with poor CD4+ T cell recovery. A total of 48 volunteers will be followed for 12 week after initiation of daily use of Lactobcillus casei Shirota or placebo, randomized in a 1:1 ratio.
We hypothesize that use of the Yakult product containing Lactobacillus casei Shirota after 12 weeks of continuous use will increase the level of CD4+ T-cells, at least, 50 cells/mm³.
We also propose to investigate several markers of immune response, including T cellular activation and NK cells function, and changes in the intestinal microbiota.
- Conditions
- HIV
- Being tested
- Fermented Milk Drink Yakult 40
- Keywords
- HIV, Lactobacillus casei Shirota, NK cell, CD4, Lymphocyte, Cell activation, Antiretroviral therapy, Immune discordants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fermented Milk Drink Yakult 40Dietary supplement
Also called Yakult, Live Lactic Bacteria (Lactobacillus casei Shirota)
Lactobacillus casei Shirota, with 40 billion bacteria per 80 g (concentration of 5 x 10^8 CFU/g). Intervention will be used for 12 weeks.
Fermented Milk Drink Yakult 40Dietary supplement
Also called Live Lactic Bacteria (Lactobacillus casei Shirota), Yakult
Ingredients: Skimmed milk and/or Reconstituted Skimmed Milk, Sugar, Glucose, Live Lactic Bacteria (Lactobacillus casei Shirota) 40 billions per 80 g - concentration of 5 x 108 CFU/g), Flavour. Gluten Free.
| Study group | Role | What they receive |
|---|---|---|
| Fermented Milk Drink Yakult 40 | Experimental | Lactobacillus casei Shirota, contained in the Fermented Milk Drink Yakult 40
Once daily Lactobacillus casei Shirota, with 40 billion bacteria per 80 g (concentration of 5 x 10^8 CFU/g). Intervention will be used for 12 weeks. Receives: Dietary Supplement: Fermented Milk Drink Yakult 40 |
| Placebo | Placebo comparator | The placebo would be an analogous product without Live Lactic Bacteria (Lactobacillus casei Shirota) presented in the same bottle and similar flavor.
Both, Yakult 40 and placebo should be stored refrigerated between 1° and 10°C and Receives: Dietary Supplement: Fermented Milk Drink Yakult 40 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase between baseline and after 6 weeks and 12 weeks in the absolute CD4+ T-cell count in active and placebo group.
Only differences greater than 50 T CD4+ cells/mm³ would be included in the analysis.
Measured: 12 weeks
Secondary outcomes (9)
Change from baseline in level of cell activation at week 12 count
Cell activation will be accessed by flow cytometry assays in a FACSCanto flow cytometer, using the following monoclonal antibodies: CD3, CD4, CD8, CD38, CCR5, CD69, anti-HLA-DR+
Measured: baseline, week 12
Change from baseline in level of cell activation at week 6
Cell activation will be accessed by flow cytometry assays in a FACSCanto flow cytometer, using the following monoclonal antibodies: CD3, CD4, CD8, CD38, CCR5, CD69, anti-HLA-DR+
Measured: baseline, week 6
Change from baseline in NK cytototoxic activity against K562 cells at week 6
NK cell phenotyping and function will be assessed according to Long et al., were subpopulations of NK cells will be assessed by the expression of CD56, CD16 molecules in the CD3-CD14-CD20- population of mononuclear cells. Production of IFNgama and CD103a proteins will be evaluated by flow cytometry in K562 stimulated mononuclear cells
Measured: baseline, week 6
Change from baseline in NK cytototoxic activity against K562 cells at week 12
NK cell phenotyping and function will be assessed according to Long et al., were subpopulations of NK cells will be assessed by the expression of CD56, CD16 molecules in the CD3-CD14-CD20- population of mononuclear cells. Production of IFNgama and CD103a proteins will be evaluated by flow cytometry in K562 stimulated mononuclear cells
Measured: baseline, week 12
Change from baseline in Intestinal symptoms score of the Inflammatory Bowel Disease Questionnaire (IBQD) at week 12
Measured: baseline, week 12
Change from baseline in the intestinal microbiome in the participants taking Lactobacillus casei Shirota at week 12
Measured: baseline, week 12
Number of participants with adverse events reasonable causal relationship with the study product in active and placebo groups
Measured: 12 weeks
Change from baseline in plasma sCD4 levels at week 6
CD14 levels will be measured using commercially available kits
Measured: baseline, week 6
Change from baseline in plasma sCD4 levels at week 12
Measured: baseline, week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2014 (estimated)
- Study startJan 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Yakult Honsha Co., LTD
- Responsible party
- Principal investigator, Esper Georges Kallás, University of Sao Paulo General Hospital
- Investigators
- Esper G Kallás, MD PhD, Principal investigator, University of Sao Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02146027
- Sponsor's protocol ID
- YAKULT
- Status last verified
- May 2017
- First submitted
- 18 Feb 2014
- Last updated
- 4 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Boyle RJ, Robins-Browne RM, Tang ML. Probiotic use in clinical practice: what are the risks? Am J Clin Nutr. 2006 Jun;83(6):1256-64; quiz 1446-7. doi: 10.1093/ajcn/83.6.1256.
PubMed 16762934Brenchley JM, Douek DC. HIV infection and the gastrointestinal immune system. Mucosal Immunol. 2008 Jan;1(1):23-30. doi: 10.1038/mi.2007.1.
PubMed 19079157Corazza GR, Ginaldi L, Furia N, Marani-Toro G, Di Giammartino D, Quaglino D. The impact of HIV infection on lactose absorptive capacity. J Infect. 1997 Jul;35(1):31-5. doi: 10.1016/s0163-4453(97)90905-1.
PubMed 9279721Fujimori S, Gudis K, Mitsui K, Seo T, Yonezawa M, Tanaka S, Tatsuguchi A, Sakamoto C. A randomized controlled trial on the efficacy of synbiotic versus probiotic or prebiotic treatment to improve the quality of life in patients with ulcerative colitis. Nutrition. 2009 May;25(5):520-5. doi: 10.1016/j.nut.2008.11.017. Epub 2009 Feb 8.
PubMed 19201576Hummelen R, Vos AP, van't Land B, van Norren K, Reid G. Altered host-microbe interaction in HIV: a target for intervention with pro- and prebiotics. Int Rev Immunol. 2010 Oct;29(5):485-513. doi: 10.3109/08830185.2010.505310.
PubMed 20839912Irvine SL, Hummelen R, Hekmat S, Looman CW, Habbema JD, Reid G. Probiotic yogurt consumption is associated with an increase of CD4 count among people living with HIV/AIDS. J Clin Gastroenterol. 2010 Oct;44(9):e201-5. doi: 10.1097/MCG.0b013e3181d8fba8.
PubMed 20463586Marchetti G, Bellistri GM, Borghi E, Tincati C, Ferramosca S, La Francesca M, Morace G, Gori A, Monforte AD. Microbial translocation is associated with sustained failure in CD4+ T-cell reconstitution in HIV-infected patients on long-term highly active antiretroviral therapy. AIDS. 2008 Oct 1;22(15):2035-8. doi: 10.1097/QAD.0b013e3283112d29.
PubMed 18784466Marchetti G, Cozzi-Lepri A, Merlini E, Bellistri GM, Castagna A, Galli M, Verucchi G, Antinori A, Costantini A, Giacometti A, di Caro A, D'arminio Monforte A; ICONA Foundation Study Group. Microbial translocation predicts disease progression of HIV-infected antiretroviral-naive patients with high CD4+ cell count. AIDS. 2011 Jul 17;25(11):1385-94. doi: 10.1097/QAD.0b013e3283471d10.
PubMed 21505312Massanella M, Negredo E, Perez-Alvarez N, Puig J, Ruiz-Hernandez R, Bofill M, Clotet B, Blanco J. CD4 T-cell hyperactivation and susceptibility to cell death determine poor CD4 T-cell recovery during suppressive HAART. AIDS. 2010 Apr 24;24(7):959-68. doi: 10.1097/QAD.0b013e328337b957.
PubMed 20177358Piketty C, Castiel P, Belec L, Batisse D, Si Mohamed A, Gilquin J, Gonzalez-Canali G, Jayle D, Karmochkine M, Weiss L, Aboulker JP, Kazatchkine MD. Discrepant responses to triple combination antiretroviral therapy in advanced HIV disease. AIDS. 1998 May 7;12(7):745-50. doi: 10.1097/00002030-199807000-00011.
PubMed 9619806Rajasuriar R, Booth D, Solomon A, Chua K, Spelman T, Gouillou M, Schlub TE, Davenport M, Crowe S, Elliott J, Hoy J, Fairley C, Stewart G, Cameron P, Lewin SR. Biological determinants of immune reconstitution in HIV-infected patients receiving antiretroviral therapy: the role of interleukin 7 and interleukin 7 receptor alpha and microbial translocation. J Infect Dis. 2010 Oct 15;202(8):1254-64. doi: 10.1086/656369.
PubMed 20812848Trois L, Cardoso EM, Miura E. Use of probiotics in HIV-infected children: a randomized double-blind controlled study. J Trop Pediatr. 2008 Feb;54(1):19-24. doi: 10.1093/tropej/fmm066. Epub 2007 Sep 17.
PubMed 17878180Tinmouth J, Kandel G, Tomlinson G, Walmsley S, Steinhart AH, Glazier R. The effect of dairy product ingestion on human immunodeficiency virus-related diarrhea in a sample of predominantly gay men: a randomized, controlled, double-blind, crossover trial. Arch Intern Med. 2006 Jun 12;166(11):1178-83. doi: 10.1001/archinte.166.11.1178.
PubMed 16772244Woelk CH, Beliakova-Bethell N, Goicoechea M, Zhao Y, Du P, Rought SE, Lozach J, Perez-Santiago J, Richman DD, Smith DM, Little SJ. Gene expression before HAART initiation predicts HIV-infected individuals at risk of poor CD4+ T-cell recovery. AIDS. 2010 Jan 16;24(2):217-22. doi: 10.1097/QAD.0b013e328334f1f0.
PubMed 19952713
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunological Effects of Continuous, Once a Day Use of Lactobacillus Casei Shirota on HIV-infected Patients on Suppressive Antiretroviral Treatment With Poor CD4+ T-cell Recovery
- ClinicalTrials.gov ID
- NCT02146027
- Acronym / sponsor ID
- YAKULT
- Conditions
- HIV
- Keywords
- HIV, Lactobacillus casei Shirota, NK cell, CD4, Lymphocyte, Cell activation, Antiretroviral therapy, Immune discordants
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Yakult Honsha Co., LTD
- Study start
- Jan 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 23 May 2014 (estimated)
- 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.
In this study, HIV-infected patients with poor recovery of CD4+ T cells and successful viral control after treatment with antiretroviral therapy will be enrolled to receive once a day Lactobcillus casei Shirota or placebo in a double-blind, randomized fashion. Immune parameters will be monitored for 12 weeks in both arms.
The main outcome is CD4+ T cell recovery. Secondary outcomes will include NK cells and T cells immune parameters.
Detailed description
In this study, HIV-infected patients with poor recovery of CD4+ T cells and successful viral control after treatment with antiretroviral therapy will be enrolled to receive once a day Lactobcillus casei Shirota or placebo in a double-blind, randomized fashion.
The main objective is to investigate whether the continuous, once a day, 12-weeks use of Yakult product containing Lactobacillus casei Shirota could affect immunological parameters in HIV-infected patients on suppressive antiretroviral treatment with poor CD4+ T cell recovery. A total of 48 volunteers will be followed for 12 week after initiation of daily use of Lactobcillus casei Shirota or placebo, randomized in a 1:1 ratio.
We hypothesize that use of the Yakult product containing Lactobacillus casei Shirota after 12 weeks of continuous use will increase the level of CD4+ T-cells, at least, 50 cells/mm³.
We also propose to investigate several markers of immune response, including T cellular activation and NK cells function, and changes in the intestinal microbiota.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fermented Milk Drink Yakult 40 | Experimental | Dietary Supplement: Fermented Milk Drink Yakult 40Lactobacillus casei Shirota, contained in the Fermented Milk Drink Yakult 40 Once daily Lactobacillus casei Shirota, with 40 billion bacteria per 80 g (concentration of 5 x 10^8 CFU/g). Intervention will be used for 12 weeks. |
| Placebo | Placebo comparator | Dietary Supplement: Fermented Milk Drink Yakult 40The placebo would be an analogous product without Live Lactic Bacteria (Lactobacillus casei Shirota) presented in the same bottle and similar flavor. Both, Yakult 40 and placebo should be stored refrigerated between 1° and 10°C and |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or female HIV-1 infected patients aged between 18 and 60 years.
- Patient on suppressive antiretroviral treatment with poor CD4+ T-cell recovery.
- No change in antiretroviral therapy in the last six months or intended change in the next 12 weeks.
- Availability for the study procedures during the study period.
- Giving informed consent to participate in the study
Key exclusion criteria (6 listed)
- Diagnosis of any concomitant infections or diseases that might affect immunity or natural history of HIV-1 infection including active Hepatitis B infection, Hepatitis C infection, diabetes mellitus, neoplasias and autoimmune diseases.
- Use of treatments that might affect immunity in the last four weeks including immunomodulators, corticosteroids (only systemic use for two weeks or more), or antineoplasic agents.
- History of intolerance or allergy to cow milk or any other component of the study product including lactose intolerance, casein allergy, etc.
- Pregnancy, nursing mother or intention of became pregnant during the study period (only female participants).
- Unable to safely store the study product at home in the conditions recommended by the manufacturer.
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 |
|---|---|---|
| Fermented Milk Drink Yakult 40Also: Yakult, Live Lactic Bacteria (Lactobacillus casei Shirota)Lactobacillus casei Shirota, with 40 billion bacteria per 80 g (concentration of 5 x 10^8 CFU/g). Intervention will be used for 12 weeks. | Dietary supplement | Fermented Milk Drink Yakult 40, Placebo |
| Fermented Milk Drink Yakult 40Also: Live Lactic Bacteria (Lactobacillus casei Shirota), YakultIngredients: Skimmed milk and/or Reconstituted Skimmed Milk, Sugar, Glucose, Live Lactic Bacteria (Lactobacillus casei Shirota) 40 billions per 80 g - concentration of 5 x 108 CFU/g), Flavour. Gluten Free. | Dietary supplement | Fermented Milk Drink Yakult 40, Placebo |
Primary outcome
Increase between baseline and after 6 weeks and 12 weeks in the absolute CD4+ T-cell count in active and placebo group.
Time frame: 12 weeks
Only differences greater than 50 T CD4+ cells/mm³ would be included in the analysis.
9 secondary outcomes
Change from baseline in level of cell activation at week 12 count
Time frame: baseline, week 12
Change from baseline in level of cell activation at week 6
Time frame: baseline, week 6
Change from baseline in NK cytototoxic activity against K562 cells at week 6
Time frame: baseline, week 6
Change from baseline in NK cytototoxic activity against K562 cells at week 12
Time frame: baseline, week 12
Change from baseline in Intestinal symptoms score of the Inflammatory Bowel Disease Questionnaire (IBQD) at week 12
Time frame: baseline, week 12
Change from baseline in the intestinal microbiome in the participants taking Lactobacillus casei Shirota at week 12
Time frame: baseline, week 12
Number of participants with adverse events reasonable causal relationship with the study product in active and placebo groups
Time frame: 12 weeks
Change from baseline in plasma sCD4 levels at week 6
Time frame: baseline, week 6
Change from baseline in plasma sCD4 levels at week 12
Time frame: baseline, week 12
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 4 May 2017.
- Results publication: PubMed 16762934Boyle RJ, Robins-Browne RM, Tang ML. Probiotic use in clinical practice: what are the risks? Am J Clin Nutr. 2006 Jun;83(6):1256-64; quiz 1446-7. doi: 10.1093/ajcn/83.6.1256.
- Results publication: PubMed 19079157Brenchley JM, Douek DC. HIV infection and the gastrointestinal immune system. Mucosal Immunol. 2008 Jan;1(1):23-30. doi: 10.1038/mi.2007.1.
- Results publication: PubMed 9279721Corazza GR, Ginaldi L, Furia N, Marani-Toro G, Di Giammartino D, Quaglino D. The impact of HIV infection on lactose absorptive capacity. J Infect. 1997 Jul;35(1):31-5. doi: 10.1016/s0163-4453(97)90905-1.
- Results publication: PubMed 19201576Fujimori S, Gudis K, Mitsui K, Seo T, Yonezawa M, Tanaka S, Tatsuguchi A, Sakamoto C. A randomized controlled trial on the efficacy of synbiotic versus probiotic or prebiotic treatment to improve the quality of life in patients with ulcerative colitis. Nutrition. 2009 May;25(5):520-5. doi: 10.1016/j.nut.2008.11.017. Epub 2009 Feb 8.
- Results publication: PubMed 20839912Hummelen R, Vos AP, van't Land B, van Norren K, Reid G. Altered host-microbe interaction in HIV: a target for intervention with pro- and prebiotics. Int Rev Immunol. 2010 Oct;29(5):485-513. doi: 10.3109/08830185.2010.505310.
- Results publication: PubMed 20463586Irvine SL, Hummelen R, Hekmat S, Looman CW, Habbema JD, Reid G. Probiotic yogurt consumption is associated with an increase of CD4 count among people living with HIV/AIDS. J Clin Gastroenterol. 2010 Oct;44(9):e201-5. doi: 10.1097/MCG.0b013e3181d8fba8.
- Results publication: PubMed 18784466Marchetti G, Bellistri GM, Borghi E, Tincati C, Ferramosca S, La Francesca M, Morace G, Gori A, Monforte AD. Microbial translocation is associated with sustained failure in CD4+ T-cell reconstitution in HIV-infected patients on long-term highly active antiretroviral therapy. AIDS. 2008 Oct 1;22(15):2035-8. doi: 10.1097/QAD.0b013e3283112d29.
- Results publication: PubMed 21505312Marchetti G, Cozzi-Lepri A, Merlini E, Bellistri GM, Castagna A, Galli M, Verucchi G, Antinori A, Costantini A, Giacometti A, di Caro A, D'arminio Monforte A; ICONA Foundation Study Group. Microbial translocation predicts disease progression of HIV-infected antiretroviral-naive patients with high CD4+ cell count. AIDS. 2011 Jul 17;25(11):1385-94. doi: 10.1097/QAD.0b013e3283471d10.
- Results publication: PubMed 20177358Massanella M, Negredo E, Perez-Alvarez N, Puig J, Ruiz-Hernandez R, Bofill M, Clotet B, Blanco J. CD4 T-cell hyperactivation and susceptibility to cell death determine poor CD4 T-cell recovery during suppressive HAART. AIDS. 2010 Apr 24;24(7):959-68. doi: 10.1097/QAD.0b013e328337b957.
- Results publication: PubMed 9619806Piketty C, Castiel P, Belec L, Batisse D, Si Mohamed A, Gilquin J, Gonzalez-Canali G, Jayle D, Karmochkine M, Weiss L, Aboulker JP, Kazatchkine MD. Discrepant responses to triple combination antiretroviral therapy in advanced HIV disease. AIDS. 1998 May 7;12(7):745-50. doi: 10.1097/00002030-199807000-00011.
- Results publication: PubMed 20812848Rajasuriar R, Booth D, Solomon A, Chua K, Spelman T, Gouillou M, Schlub TE, Davenport M, Crowe S, Elliott J, Hoy J, Fairley C, Stewart G, Cameron P, Lewin SR. Biological determinants of immune reconstitution in HIV-infected patients receiving antiretroviral therapy: the role of interleukin 7 and interleukin 7 receptor alpha and microbial translocation. J Infect Dis. 2010 Oct 15;202(8):1254-64. doi: 10.1086/656369.
- Results publication: PubMed 17878180Trois L, Cardoso EM, Miura E. Use of probiotics in HIV-infected children: a randomized double-blind controlled study. J Trop Pediatr. 2008 Feb;54(1):19-24. doi: 10.1093/tropej/fmm066. Epub 2007 Sep 17.
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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.
Esper G Kallás, MD PhD principal investigator
University of Sao Paulo General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fermented Milk Drink Yakult 40 in people with HIV, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 6 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 4 May 2017. 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 Brazil. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Increase between baseline and after 6 weeks and 12 weeks in the absolute CD4+ T-cell count in active and placebo group. (time frame: 12 weeks). 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 NCT02146027, which also lists 14 linked publications.
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 4 May 2017.