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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03008941
Other study ID # 165-16
Secondary ID GESIDA 9116
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date January 2017
Est. completion date October 2018

Study information

Verified date October 2018
Source Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Altered interplay between gut mucosa and dysbiotic bacteria during HIV infection seems to contribute to chronic immune dysfunction. Manipulation of the intestinal microbiota with nutritional interventions exert limited immunologic effects, but a deep understanding of how these interventions could ameliorate gut dysbiosis and influence health among HIV-infected individuals remain unexplored. In this Phase I clinical trial, 30 HIV-infected subjects on effective ART with evidence of persistent immune dysfunction, indicated by a CD4/CD8 ratio<1 will be included and randomized to either repeated low-dose oral fecal microbiota transplantation or placebo during 8 weeks. The primary outcome will be safety. Secondary outcomes will include changes in CD4+ T cell counts, CD8+ T cell counts, CD4/CD8 ratio, inflammatory markers, T cell activation and markers of enterocyte barrier function through week 48. Engraftment on host microbiota will be examined using Illumina sequencing of the V3-V4 16S RNA, and changes in bacterial metabolism and in the plasma metabolite fingerprint will be studied by combination of untargeted mass spectrometry and two different and complementary separation techniques in bacterial and plasma samples.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date October 2018
Est. primary completion date June 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- On stable antiretroviral therapy with plasma HIV RNA <20 copies/mL during at least 48 weeks.

- CD4/CD8 ratio <1

Exclusion Criteria:

- Pregnancy

- Gastrointestinal diseases, including cirrhosis

- Active infections, including HCV

- EBV and/or CMV negative patients (donors are not screened for EBV/CMV).

- Planned used of chemotherapy or antibiotics

- Allergy to sodium chloride or glycerol (the former components are capsule ingredients Generally Recognized As Safe (GRAS)

- Current or planned use of antimicrobial agents (including prophylactic treatments against P. jiroveci) other than ART.

- Neutropenia <500 cells/uL or CD4 counts <350 cells/uL

- Patients unable to give informed consent

- Patients unable to comply with the protocol requirements

- Predicted death within time period of follow-up

- Any other condition for which the treating physician thinks the treatment may pose a health risk

- Dysphagia: oropharyngeal, esophageal, functional, neuromuscular (e.g. stroke, multiple sclerosis, ALS)

- History of aspiration

- History of gastroparesis

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
FMT
Capsules with fecal microbiota from healthy donors
Other:
Placebo
Placebo capsules

Locations

Country Name City State
Spain Hospital Ramón y Cajal Madrid

Sponsors (1)

Lead Sponsor Collaborator
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 From baseline through week 48
Secondary Changes in CD4+ T cell counts From baseline through week 48
Secondary Changes in CD8+ T cell counts Inflammation: interleukin (IL)-6, high sensitivity C reactive protein (hs-CRP), interferon gamma-induced protein (IP)-10.
Monocyte/macrophage activation: sCD14, SCD163,
Gut epithelial integrity: zonulin-1, intestinal fatty acid binding protein (IFABP).
Bacterial translocation: lipoteichoic acid (LTA)
Indolamine deoxygenase-1 induction: kynurenine/tryptophan ratio
Coagulation: D-dimers
From baseline through week 48
Secondary Changes in CD4/CD8 ratio Inflammation: interleukin (IL)-6, high sensitivity C reactive protein (hs-CRP), interferon gamma-induced protein (IP)-10.
Monocyte/macrophage activation: sCD14, SCD163,
Gut epithelial integrity: zonulin-1, intestinal fatty acid binding protein (IFABP).
Bacterial translocation: lipoteichoic acid (LTA)
Indolamine deoxygenase-1 induction: kynurenine/tryptophan ratio
Coagulation: D-dimers
From baseline through week 48
Secondary Changes in microbiota alpha diversity metrics From baseline through week 48
Secondary Changes in microbiota Unifrac distances From baseline through week 48
Secondary Changes in microbiota Canberra distances From baseline through week 48
Secondary Changes in plasma Interleukin-6 levels From baseline through week 48
Secondary Changes in plasma hs-CRP levels From baseline through week 48
Secondary Changes in plasma lipoteichoic acid levels From baseline through week 48
Secondary Changes in plasma LBP levels From baseline through week 48
Secondary Changes in plasma kynurenine/tryptophan ratio From baseline through week 48
Secondary Percentage of HLA-DR+/CD38+ T cells in blood From baseline through week 48
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