Xla1 Christensenella Minuta, Phase I, Randomized, Partially Placebo-controlled Double-blind Protocol, Evaluating Safety, Tolerability and Impact on the Gut Microbiota in Healthy Volunteers, Overweight and Obese Adults
Condition: Obesity; Metabolic Disease
MeSH terms: Overweight; Metabolic Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      Xla1 Christensenella minuta, phase I, randomized, placebo-controlled double-blind protocol,
      evaluating safety, tolerability and impact on the gut microbiota in healthy volunteers,
      overweight and obese adults. This study is designed as a FIH, Phase I, daily oral single
      dose, clinical trial evaluating safety, tolerability and the impact on the gut microbiota
      following introduction of Xla1 performed in 2 parts:

        -  Part 1: An open phase in normal weight healthy volunteers (HV) receiving all Xla1.

        -  Part 2: A randomized, parallel, double-blind, placebo-controlled phase in overweight or
           obese (stage 1) adult patients receiving either Xla1 or placebo.
    

Detailed description: 
      Xla1 Christensenella minuta, phase I, randomized, placebo-controlled double-blind protocol,
      evaluating safety, tolerability and impact on the gut microbiota in healthy volunteers,
      overweight and obese adults. This study is designed as a FIH, Phase I, daily oral single
      dose, clinical trial evaluating safety, tolerability and the impact on the gut microbiota
      following introduction of Xla1 performed in 2 parts:

        -  Part 1: An open phase in normal weight healthy volunteers (HV) receiving all Xla1.

        -  Part 2: A randomized, parallel, double-blind, placebo-controlled phase in overweight or
           obese (stage 1) adult patients receiving either Xla1 or placebo.

      The following objectives will be addressed in the program: 1) the primary objective of the
      study is to assess the safety and tolerability of Xla1 in Healthy adult Volunteers (HV) [part
      1], and, subsequently, in overweight and Stage I obese adults [part 2]. 2) the secondary
      objectives comprise additional evaluation of the effects of Xla1 on subject's intestinal
      microbiome ecology and evaluation of the engraftment of Xla1 in the gastrointestinal tract
      (GIT).
    

Intervention name(s): Xla1; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Xla1 is a Live Biotherapeutic Product (LBP) containing a strain of the bacteria Christensenella minuta (C. minuta); Matching placebo
Other intervention name(s): Matching placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study is designed as a First in Human, Phase I, clinical trial evaluating safety, tolerability and the impact on the gut microbiota of Xla1. The study will be performed in 2 parts:
Part 1: An open label phase in normal weight healthy adult volunteers receiving Xla1.
Part 2: A randomized, parallel, double-blind, placebo-controlled phase I in overweight and class 1 obese adult patients receiving either Xla1 or placebo.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: obesity; LBP; Xla1