Study: NCT06503978

Intervention type: COMBINATION_PRODUCT
Group type: EXPERIMENTAL
Intervention: MTP-101P
Description: MTP-101P is comprised of standardized dose of total fecal microbiota purified from the stool of healthy donors. Donors are carefully screened via health status questionnaires, physical examinations, reviews of comprehensive medical history, clinical laboratory evaluations, serologic and genomic tests for infectious diseases and metabolic health, and stool-related pathogen testing. The material from the donors is purified to remove the majority of non-bacterial material, washed, lyophilized, and provided to the patient in a sachet contained within a mixing bottle.

Intervention type: COMBINATION_PRODUCT
Group type: EXPERIMENTAL
Intervention: MTP-101P
Description: MTP-101P is comprised of standardized dose of total fecal microbiota purified from the stool of healthy donors. Donors are carefully screened via health status questionnaires, physical examinations, reviews of comprehensive medical history, clinical laboratory evaluations, serologic and genomic tests for infectious diseases and metabolic health, and stool-related pathogen testing. The material from the donors is purified to remove the majority of non-bacterial material, washed, lyophilized, and provided to the patient in a sachet contained within a mixing bottle.

Intervention type: COMBINATION_PRODUCT
Group type: EXPERIMENTAL
Intervention: Vancomycin
Description: Oral vancomycin is an antibiotic used for treating C. difficile-associated diarrhea and staphylococcal-induced enterocolitis.~Duration: 14 Days

Intervention type: COMBINATION_PRODUCT
Group type: EXPERIMENTAL
Intervention: Vancomycin
Description: Oral vancomycin is an antibiotic used for treating C. difficile-associated diarrhea and staphylococcal-induced enterocolitis.~Duration: 14 Days

Intervention type: COMBINATION_PRODUCT
Group type: EXPERIMENTAL
Intervention: Miralax
Description: Miralax is a common over-the-counter laxative and bowel cleanse

Intervention type: COMBINATION_PRODUCT
Group type: EXPERIMENTAL
Intervention: Miralax
Description: Miralax is a common over-the-counter laxative and bowel cleanse

Intervention type: COMBINATION_PRODUCT
Group type: PLACEBO_COMPARATOR
Intervention: Miralax
Description: Miralax is a common over-the-counter laxative and bowel cleanse

Intervention type: COMBINATION_PRODUCT
Group type: PLACEBO_COMPARATOR
Intervention: Miralax
Description: Miralax is a common over-the-counter laxative and bowel cleanse

Intervention type: COMBINATION_PRODUCT
Group type: EXPERIMENTAL
Intervention: Antacid
Description: The antacid will be aluminum/magnesium hydroxide, 1x/day, 5 minutes before the MTP-101P. Each 5 ml consists of Aluminum Hydroxide - 200 mg, Magnesium Hydroxide - 200 mg, and Simethicone - 20 mg. If some participants cannot tolerate the aluminum/magnesium hydroxide, we will allow calcium carbonate alternatives equivalent in acid neutralizing capacity.~Duration: 12 weeks

Intervention type: COMBINATION_PRODUCT
Group type: EXPERIMENTAL
Intervention: Antacid
Description: The antacid will be aluminum/magnesium hydroxide, 1x/day, 5 minutes before the MTP-101P. Each 5 ml consists of Aluminum Hydroxide - 200 mg, Magnesium Hydroxide - 200 mg, and Simethicone - 20 mg. If some participants cannot tolerate the aluminum/magnesium hydroxide, we will allow calcium carbonate alternatives equivalent in acid neutralizing capacity.~Duration: 12 weeks

Intervention type: COMBINATION_PRODUCT
Group type: PLACEBO_COMPARATOR
Intervention: Placebo MTP-101P
Description: The same packaging will be used as for MTP-101P, but the sachets will contain a freeze-dried mixture of normal saline containing 10% Trehalose.~Duration: 12 weeks

Intervention type: COMBINATION_PRODUCT
Group type: PLACEBO_COMPARATOR
Intervention: Placebo MTP-101P
Description: The same packaging will be used as for MTP-101P, but the sachets will contain a freeze-dried mixture of normal saline containing 10% Trehalose.~Duration: 12 weeks

Intervention type: COMBINATION_PRODUCT
Group type: PLACEBO_COMPARATOR
Intervention: Placebo Vancomycin
Description: Same packaging and liquid carrier and flavoring used as for the oral vancomycin, but no vancomycin.~Duration: 14 days

Intervention type: COMBINATION_PRODUCT
Group type: PLACEBO_COMPARATOR
Intervention: Placebo Vancomycin
Description: Same packaging and liquid carrier and flavoring used as for the oral vancomycin, but no vancomycin.~Duration: 14 days