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WithdrawnNCT03163784SHIFTUpdated Nov 15, 2018

SHIFT: Studying HIV Immunology After Fecal Transplant

A Phase 1/2 interventional study of Fecal Inoculum Capsule and Placebo (for Fecal Inoculum Capsule) in HIV/AIDS, Dysbiosis and Inflammation, sponsored by Massachusetts General Hospital. Withdrawn. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-11-15.

Sponsored by Massachusetts General Hospital · Phase 1/2, Interventional, and Supportive care

Why this study was withdrawn
The study closed because of shifting research priorities and interests.
Phase
Phase 1/2
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
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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).

Read the detailed description

This study is designed to test the safety and tolerability of Fecal Microbiota Transplant (FMT) in HIV infected individuals on stable antiretroviral therapy (ART). Additionally, the study will examine potential effects of FMT on HIV immune activation, which has been linked to HIV disease progression.

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Conditions studied

  • HIV/AIDS
  • Dysbiosis
  • Inflammation
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In context

Inflammation

3,438 studies on the registry are indexed under Inflammation; 629 are open to participants now.

Browse Inflammation studies →

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.

Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Men and women ages 18 - 75 years.
  2. HIV-1 positive:
  3. Ability and willingness of participant or legal guardian/representative to provide informed consent.

Exclusion criteria

Exclusion Criteria:

  1. Patients with a history of significant allergy to tree nuts, peanuts, shellfish, and/or eggs, vancomycin, levofloxacin, or metronidazole, chocolate/cocoa or gelatin; or unwillingness to ingest gelatin (in placebo capsules)
  2. Use of investigational therapies or investigational vaccines within 90 days prior to study entry
  3. Serious illness requiring systemic treatment and/or hospitalization within 30 days prior to entry
  4. History of positive HCV antibody with detectable HCV RNA in plasma within 48 weeks prior to study entry.
  5. History of positive HBsAg within 48 weeks prior to study entry
  6. Liver cirrhosis, history of C. difficile infection, history of inflammatory bowel disease, bariatric surgery, total colectomy, colon or rectal anastomosis, bowel resection, or current colostomy.
  7. Current diagnosis of diabetes
  8. BMI >35
  9. Either breastfeeding or pregnant within 24 weeks prior to study entry
  10. Tendinopathy or peripheral neuropathy (potentially exacerbated by antibiotic pretreatment)
  11. Use of immunosuppressives, immune modulators, or antineoplastic agents for more than 3 consecutive days within the 60 days prior to study entry.
  12. Use of probiotics and prebiotics (supplements and products) within 30 days of the study. Yogurt with live cultures is allowed.
  13. Diagnosed bacterial enteric infection within 30 days prior to study entry.
  14. Acute diarrhea within 30 days of study entry.
  15. Weight loss or gain of more than 25 pounds in the 24 weeks prior to study entry.
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Study design

Phase
Phase 1 / Phase 2
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Single group
Masking
Double (Participant, Investigator)
Enrollment
0 participants (actual)

Study arms

  • Placebo comparator
    Arm A

    Weekly placebo (for Fecal Inoculum Capsule) treatment with placebo pre-treatment.

    Biological: Placebo (for Fecal Inoculum Capsule) · Drug: Antibiotic Placebo

  • Experimental
    Arm B

    Weekly Fecal Inoculum Capsule treatment with placebo pre-treatment.

    Biological: Fecal Inoculum Capsule · Drug: Antibiotic Placebo

  • Experimental
    Arm C

    Weekly Fecal Inoculum Capsule treatment with antibiotic pre-treatment.

    Biological: Fecal Inoculum Capsule · Drug: Antibiotic

Interventions

  • BiologicalFecal Inoculum Capsule

    Sieved fecal matter prepared in glycerol/saline solution

  • BiologicalPlacebo (for Fecal Inoculum Capsule)

    Placebo capsule manufactured to mimic Fecal Inoculum Capsules

    Also known as: Placebo

  • DrugAntibiotic

    Antibiotic pre-treatment

  • DrugAntibiotic Placebo

    Placebo tablets manufactured to mimic antibiotics

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What researchers measure

Primary outcomes

  1. FMT-related adverse events

    Safety of FMT in stably suppressed HIV infected recipients on ART

    Time frame: 30 weeks

Secondary outcomes

  1. Immune and metabolic markers

    Changes in immune and metabolic markers such as CD4 T cell activation and sCD14 levels.

    Time frame: 30 weeks

  2. Microbiome structure

    Identify and characterize how FMT alters enteric microbiome structure.

    Time frame: 30 weeks

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 15, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03163784
Lead sponsor
Massachusetts General Hospital
Responsible party
DOUGLAS KWON (Principal Investigator, Massachusetts General Hospital) — Principal investigator
First posted
May 23, 2017
Start date
Jun 2018 (estimated)
Primary completion
Jun 2020 (estimated)
Completion
Jun 2022 (estimated)
Last update
Nov 15, 2018

Study contacts

Douglas Kwon, MD, PhD
principal investigator · Massachusetts General Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

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