Microbiota Restoration Therapy in HIV With Repeated Low-Dose Interventions (REFRESH)
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ClinicalTrials.gov Identifier: NCT03008941 |
Recruitment Status :
Completed
First Posted : January 4, 2017
Last Update Posted : October 30, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infection | Biological: FMT Other: Placebo | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Phase I/II Randomized, Double-Blind, Placebo Controlled Study of Repeated Low-Dose Fecal Microbiota Restoration in HIV-Infected Subjects. The REFRESH Study |
Actual Study Start Date : | January 2017 |
Actual Primary Completion Date : | June 2018 |
Actual Study Completion Date : | October 2018 |
Arm | Intervention/treatment |
---|---|
Experimental: FMT
Fecal microbiota capsules (provided by Openbiome). Dosage:
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Biological: FMT
Capsules with fecal microbiota from healthy donors |
Placebo Comparator: Placebo
Placebo capsules (provided by Openbiome). Dosage:
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Other: Placebo
Placebo capsules |
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: From baseline through week 48 ]
- Changes in CD4+ T cell counts [ Time Frame: From baseline through week 48 ]
- Changes in CD8+ T cell counts [ Time Frame: From baseline through week 48 ]
- 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
- Changes in CD4/CD8 ratio [ Time Frame: From baseline through week 48 ]
- 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
- Changes in microbiota alpha diversity metrics [ Time Frame: From baseline through week 48 ]
- Changes in microbiota Unifrac distances [ Time Frame: From baseline through week 48 ]
- Changes in microbiota Canberra distances [ Time Frame: From baseline through week 48 ]
- Changes in plasma Interleukin-6 levels [ Time Frame: From baseline through week 48 ]
- Changes in plasma hs-CRP levels [ Time Frame: From baseline through week 48 ]
- Changes in plasma lipoteichoic acid levels [ Time Frame: From baseline through week 48 ]
- Changes in plasma LBP levels [ Time Frame: From baseline through week 48 ]
- Changes in plasma kynurenine/tryptophan ratio [ Time Frame: From baseline through week 48 ]
- Percentage of HLA-DR+/CD38+ T cells in blood [ Time Frame: From baseline through week 48 ]

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03008941
Spain | |
Hospital Ramón y Cajal | |
Madrid, Spain, 28034 |
Responsible Party: | Sergio Serrano-Villar, MD, PhD, Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal |
ClinicalTrials.gov Identifier: | NCT03008941 |
Other Study ID Numbers: |
165-16 GESIDA 9116 ( Other Identifier: GESIDA Study group ) |
First Posted: | January 4, 2017 Key Record Dates |
Last Update Posted: | October 30, 2018 |
Last Verified: | October 2018 |
HIV microbiota inflammation fecal microbiota restoration |
HIV Infections Blood-Borne Infections Communicable Diseases Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases |
Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Immunologic Deficiency Syndromes Immune System Diseases |