This is a two-part, randomized, double-blind, placebo-controlled, single center study to investigate the safety and tolerability of XBI-302 administered orally in healthy volunteers. The hypothesis of this study is that XBI-302 is safe and well tolerated with the proposed dosing regimens.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
36
Fecal Microbiota Transplantation Capsules
XBI-302 Placebo
Bejing Goboard Boren Hospital
Beijing, China
RECRUITINGThe incidence and severity of all AEs and SAEs
The incidence and severity of all AEs and SAEs that are determined to be related to XBI-302 through Day 28.
Time frame: Day 28
The incidence of all AEs and SAEs
The incidence of all AEs and SAEs through Day 28 and Week 12.
Time frame: Day 28 and Week 12
Change in laboratory data of pre- and post-intervention as a measure of safety.
Compare changes laboratory data via hematology, blood chemistry, urinalysis, and routine stool testing before and after using FMT capsules.
Time frame: Baseline, Weeks 1, 2, 3, 4, and 12 (if applicable for the arm)
Change in functions of all organ systems via standard complete physical examinations.
Change in functions of all organ systems via standard complete physical examinations.
Time frame: Baseline, Weeks 1, 2, 3, 4, and 12 (if applicable for the arm)
Change in functions of heart, lungs, abdomen and other organ that involve the gastrointestinal tract and digestive system via targeted physical examinations.
Change in functions of heart, lungs, abdomen and other organ that involve the gastrointestinal tract and digestive system via targeted physical examinations.
Time frame: Baseline, Weeks 1, 2, 3, 4, and 12 (if applicable for the arm)
Change in vital signs in ear temperature, pulse, respirations, and blood pressure as a measure of safety.
Change in vital signs in ear temperature, pulse, respirations, and blood pressure as a measure of safety.
Time frame: Baseline, Weeks 1, 2, 3, 4, and 12 (if applicable for the arm)
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The incidence of gastrointestinal AEs
Compare the incidence of gastrointestinal AEs on the dosing day(s) between treatment groups.
Time frame: Weeks 1, 2, 3, and 4 (if applicable for the arm)
The level of difficulty of swallowing FMT capsules as a measure of tolerability.
Estimate degree of difficulty of swallowing FMT capsules via daily diary cards by selecting easy, ok, hard (must rest frequently to complete all capsules), or very hard (stuck to my throat all the time, took a long time to finish all capsules).
Time frame: Weeks 1, 2, 3, and 4 (if applicable for the arm)
The subjective experience of the taste acceptance as a measure of tolerability.
Estimate degree of taste acceptance of FMT capsules via daily diary cards by selecting none, ok, a strange taste, or strong taste that makes me nauseous.
Time frame: Weeks 1, 2, 3, and 4 (if applicable for the arm)
The gut microbiome profile
Compare the gut microbiome profile before and after the transplantation between treatment groups.
Time frame: Baseline, Weeks 1, 2, 3, 4, 6, 8, 10, and 12 (if applicable for the arm)
The gut microbiome profile
Compare the gut microbiome profile before and after the transplantation between donors and participants.
Time frame: Baseline, Weeks 1, 2, 3, 4, 6, 8, 10, and 12 (if applicable for the arm)
The colonization of microbiota from donor
Compare the effects of diet and lifestyle on the colonization of microbiota from donor before and after FMT.
Time frame: Baseline, Weeks 1, 2, 3, 4, 6, 8, 10, and 12 (if applicable for the arm)