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Fecal Microbiota Transplantation as a Therapeutic Strategy for Patients Infected With HIV

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04165200
Recruitment Status : Completed
First Posted : November 15, 2019
Last Update Posted : April 28, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. Adrian Camacho-Ortiz, Hospital Universitario Dr. Jose E. Gonzalez

Brief Summary:

Patients eligible for the study will be selected on Fridays during the HIV consultation at the Infectious Diseases Department. Patients that meet the inclusion and exclusion criteria, will be randomized and assigned in two groups 1:1. A group will start intervention with FMT (fecal matter transplant) through frozen capsules and after seven days, antiretroviral therapy (ART) will be started. Patients in the other group will be given placebo capsules and after seven days ART will be started. The frozen capsules of FMT will be ingested orally with a frequency of 15 capsules every 12 hours for 4 doses 7 days prior ART start and on weeks 0, 4, 8 and 12 after ART start. Subsequently, blood samples will be taken to monitor the immune status with CD4 T lymphocytes and HIV viral load during week 0, 4, 8, 12 and 24 after ART start.

Throughout the study period, subjects can carry out a free diet, moderate alcohol intake, perform their daily activities and abstain from any of the elimination criteria. Medical consultations will be made on days -7 to ART start, day 1, 30, 60, 90 and 120 after ART start, where clinical examination and elimination criteria will be evaluated.


Condition or disease Intervention/treatment Phase
HIV Infections Diagnostic Test: Blood and feces samples Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective controlled study experimental comparative
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Neither patients, nor investigators are allowed to know about which group of patients is going to receive placebo and which one faecal microbiota capsules. The laboratory that provide us the capsules is going to divide and randomize our sample of patients, and also register the information in a data base.
Primary Purpose: Treatment
Official Title: Fecal Microbiota Transplantation as a Therapeutic Strategy for Patients Infected With HIV
Actual Study Start Date : September 6, 2018
Actual Primary Completion Date : June 10, 2019
Actual Study Completion Date : January 20, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Patients receiving FMT capsules and ART
  1. ART Start at week 0 non-stop.
  2. FMT. The frozen capsules will be ingested orally at a frequency of 15 capsules every 12 hours for four doses 7 days prior ART start and on weeks 0, 4, 8 and 12 after ART start. Each capsule must be ingested over a period no longer than 1 hour of the anterior capsule.
  3. Blood samples Week 0, 4, 8, 12 and 24. Taken through peripheral vein puncture with the extraction of 10 ml of venous blood to monitor the CD4 lymphocytes count and HIV viral load.
  4. Feces samples from each patient will be taken during medical consultation on week 0, 8 and 24 after ART start to evaluate the modification of the intestinal microbiome.
  5. Medical consultations will be made on days -7 to ART start, day 1, 30, 60, 90 and 120 after ART start, where clinical examination and elimination criteria will be evaluated.
Diagnostic Test: Blood and feces samples

Blood samples are going to be taken by puncturing peripheral vein extraction with 10 ml of venous blood for later biweekly to monitor in person and therefore monitor immune status with biomarkers T lymphocyte subclass CD4 and viral load. A total of four blood samples will be taken at weeks 4, 8, 12 and 24 of recruitment.

A total of four feces samples are going to be required during the study, to evaluate the changes on the microbiota of the patient. 1 week before the patients start their HAART, the same day the patients initiate their HAART, 8 weeks after they started HAART and 24 weeks after HAART.


Placebo Comparator: Patients receiving placebo capsules
  1. ART Start at week 0 non-stop.
  2. Placebo capsules. The frozen capsules will be ingested orally at a frequency of 15 capsules every 12 hours for four doses 7 days prior ART start and on weeks 0, 4, 8 and 12 after ART start. Each capsule must be ingested over a period no longer than 1 hour of the anterior capsule.
  3. Blood samples Week 0, 4, 8, 12 and 24. Taken through peripheral vein puncture with the extraction of 10 ml of venous blood to monitor the CD4 lymphocytes count and HIV viral load.
  4. Feces samples from each patient will be taken during medical consultation on week 0, 8 and 24 after ART start to evaluate the modification of the intestinal microbiome.
  5. Medical consultations will be made on days -7 to ART start, day 1, 30, 60, 90 and 120 after ART start, where clinical examination and elimination criteria will be evaluated.
Diagnostic Test: Blood and feces samples

Blood samples are going to be taken by puncturing peripheral vein extraction with 10 ml of venous blood for later biweekly to monitor in person and therefore monitor immune status with biomarkers T lymphocyte subclass CD4 and viral load. A total of four blood samples will be taken at weeks 4, 8, 12 and 24 of recruitment.

A total of four feces samples are going to be required during the study, to evaluate the changes on the microbiota of the patient. 1 week before the patients start their HAART, the same day the patients initiate their HAART, 8 weeks after they started HAART and 24 weeks after HAART.





Primary Outcome Measures :
  1. Levels of CD4 cells [ Time Frame: 6 months ]
    The efficacy of FMT in obtaining a faster immunologic response measured in rise of CD4 lymphocyte countTMF capsules, will have a faster rise in cell count than those who don´t receive them.


Secondary Outcome Measures :
  1. Tolerability of FMT capsules [ Time Frame: 6 months ]
    Number of Participants with FMT related Adverse Events



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Patients over 18 years
  • Confirmed HIV infection with any CD4 lymphocyte count
  • Patients at the beginning of the study only taking antibiotic prophylaxis according to the CD4 lymphocyte count
  • Patients agree to participate in the study through a signed informed consent

Exclusion criteria:

  • Patients receiving probiotics
  • Patients with anatomical abnormalities of the digestive tract such as colostomy or ileostomy
  • Patients with previous bowel resection
  • Patients with impaired AST and / or ALT greater than 4 times its normal value
  • Hemodialysis patients Patients with gastrointestinal bleeding in the last 12 weeks
  • Patients undergoing colonoscopy in the last 12 weeks

Information from the National Library of Medicine

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): NCT04165200


Locations
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Mexico
Hospital Universitario José E. Gonzalez
Monterrey, Nuevo Leon, Mexico, 64460
Sponsors and Collaborators
Hospital Universitario Dr. Jose E. Gonzalez
Publications:

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Responsible Party: Dr. Adrian Camacho-Ortiz, Dr. Adrian Camacho Ortiz, Hospital Universitario Dr. Jose E. Gonzalez
ClinicalTrials.gov Identifier: NCT04165200    
Other Study ID Numbers: IF18-00008
First Posted: November 15, 2019    Key Record Dates
Last Update Posted: April 28, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Adrian Camacho-Ortiz, Hospital Universitario Dr. Jose E. Gonzalez:
HIV infection, fecal microbiota transplantation
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases