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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |

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 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Patients receiving FMT capsules and ART
|
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
|
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. |
- 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.
- Tolerability of FMT capsules [ Time Frame: 6 months ]Number of Participants with FMT related Adverse Events

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

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
Mexico | |
Hospital Universitario José E. Gonzalez | |
Monterrey, Nuevo Leon, Mexico, 64460 |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
HIV infection, fecal microbiota transplantation |
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |