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SHIFT: Studying HIV Immunology After Fecal Transplant

NCT03163784 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2018-11-15

No results posted yet for this study

Summary

SHIFT is a randomized, longitudinal, prospective, blinded, three-arm study to determine the safety and tolerability of Fecal Microbiota Transplant (FMT) in HIV-infected participants on stable antiretroviral therapy (ART).

Conditions

Interventions

BIOLOGICAL

Fecal Inoculum Capsule

Sieved fecal matter prepared in glycerol/saline solution

BIOLOGICAL

Placebo (for Fecal Inoculum Capsule)

Placebo capsule manufactured to mimic Fecal Inoculum Capsules

DRUG

Antibiotic

Antibiotic pre-treatment

DRUG

Antibiotic Placebo

Placebo tablets manufactured to mimic antibiotics

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Douglas Kwon, MD, PhD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-30
Primary Completion
2020-06-30
Completion
2022-06-30
FDA Drug
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03163784 on ClinicalTrials.gov