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

 -  Medical history, body weight, no medication uses such as antibiotics and proton pump
 inhibitors, no trips and no diarrhea 6 months prior donation.

 -  The absence of chronic infections such as Hepatitis B, Hepatitis C, and HIV determined
 by immunoassay.

 -  Negative Rose Bengal test and V.D.R.L

 -  Normal complete blood count and liver function tests.

 Fecal sample analysis:

 1. Fresh microscopy analysis to detect leukocytes and parasites (including protozoa and
 helminths)

 2. Stool culture to rule out the presence of enteropathogens, including Salmonella spp.,
 Shigella spp., Aeromonas spp., Plesiomonas spp., Vibrio spp. and Clostridiodes diffcile.

 3. 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.

 4. Detection of genes associated with drug resistance by endpoint PCR; including genes
 encoding extended spectrum beta-lactamases (TEM, CTX; SHV, CMY) and carbapenemases (VIM,
 NDM, IMP, KPC, OXA-48).

 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.
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