An interventional study of Blood and feces samples in HIV Infections, sponsored by Hospital Universitario Dr. Jose E. Gonzalez. Completed at 1 site in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-28.
Sponsored by Hospital Universitario Dr. Jose E. Gonzalez · Not applicable, Interventional, and Treatment
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.
Study design: Prospective controlled study experimental comparative Study duration: 1 year The number of patients to enroll: 20 patients. After being randomized, selected patients who meet the criteria for inclusion and exclusion will be assigned 1:1 in two groups. A group will start treatment with FMT through frozen capsules, and ART at the same time; and another group will star placebo capsules and ART.
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.
Subsequently, blood samples will be taken through peripheral vein puncture with the extraction of 10 ml of venous blood to monitor the immune status with CD4 T lymphocytes and HIV viral load. A total of 4 blood samples will be taken during week 4, 8, 12 and 24 after ART start.
Medical consultations will be made every 4 weeks, on days -7 days prior ART start, day 1, 30, 60, 90 and 120 where vital signs, symptoms or signs of organ systems, determination of weight, BMI, adverse effects and elimination criteria will be assessed.
In addition, 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 after the intervention on both groups.
During the study period, subjects may carry a free diet, moderate intake of alcohol and perform their daily activities as they refrain free from any of the elimination criteria.
The study will last 1 year and the samples taken will be frozen and stored in the Infectious Diseases Department of the Hospital.
Selection of Fecal Microbiota donors:
The selection of fecal microbiota donors is based on:
Fecal sample analysis:
Gastrointestinal panel by multiple polymerase chain reaction (PCR) using BioFire Filmarray which includes the detection of:
Bacteria: Campylobacter (C. jejuni, C. coi, C. upsaliensis), Clostridiodes difficile (toxins A / B), Plesiomonas shigelloides, Salmonella spp., Yersinia enterocolitica, Vibrio (V. parahaemolytic , V. vulnificus and V. cholerae), Escherichia coli O157: H7, enteroaggregative E. coli (EAEC), enteropathogenic E. coli (EPEC), enterotoxigenic E. coli (ETEC), Shiga toxin producing E. coli (STEC) stx1 / stx2, Shigella sp. enteroinvasive E. coli (EIEC).
Virus: Adenovirus F 40/41, Astrovirus, Norovirus GI / GII, Rotavirus A, Sapovirus (I, II, IV and V) Parasites: Cryptosporidium sp., Cyclospora cayetanensis, Entamoeba histolytica and Giardia lamblia.
Once all the stages of evaluation are completed only negative subjects for all the tests and in which there is no evidence of infection are selected as donors. The scrutiny and laboratory tests are considered valid during the following 4 weeks, so if new donation of feces is required, the process will be carried out again.
Sample Preparation fecal microbiota All samples will be mixed with 10% glycerol and frozen at -70°C in a period not exceeding 60 minutes after collection. They will be mixed and then suspended in saline 0.9%. The final mixture will be filtered to remove particles greater than 330 microns, finally adding glycerol as cryoprotectant. This mixture is carried to the encapsulation process using sterile capsules for enteral liberation, in two sizes. The first capsule is filled with a mixture of feces and sealed with its counterpart, and then the sealed capsule becomes encapsulated in a second capsule. The final product is stored frozen until 60 minutes before use. The administration will only be oral.
4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 22 is below the median of 83 across 3,251 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →Hospital Universitario Dr. Jose E. Gonzalez is the lead sponsor of 79 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
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
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.
Levels of CD4 cells
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.
Time frame: 6 months
Tolerability of FMT capsules
Number of Participants with FMT related Adverse Events
Time frame: 6 months
This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hospital Universitario Dr. Jose E. Gonzalez