Ginger and Gut Microbiome (GINGER)
Condition: Colorectal Adenoma
MeSH terms: Adenoma
Study type: Interventional

Summary: 
      Estimate the impact of a 6-week daily intake of 2000 mg of ginger extract on the composition
      of the gut microbiome using a randomized placebo-controlled double-blinded design, i.e.
      examine the change of microbiome over time within and between the subjects..
    

Detailed description: 
      This is a pilot trial to evaluate the feasibility of conducting a large randomized trial and
      estimate the effects of ginger extract on the gut microbiome. The pilot study will recruit
      from multiple sites 95-100 subjects aged 50-75 years old who were diagnosed with colorectal
      adenoma within the last five years. There will be 47-50 subjects in the treatment group and
      47-50 in the placebo group. The subjects will be randomized to receive either 2000 mg of
      ginger extract per day (1000 mg twice a day) or matching placebo.

      Subjects will provide three stool specimens for analysis of the intestinal microbiome over a
      12-week period at the following intervals: Week 0 (Day 1), Week 6, and Week 12. Although the
      gut microbiome is stable within a period of 1-2 months, a control arm will be included to
      account for potential dietary and other changes that may affect the gut microbiome. Gut
      microbiome composition - the presence, abundance, and diversity of bacterial taxa - will be
      derived by sequencing microbial 16S ribosomal RNA genes.

      Primary Aims:

      Aim 1 is to estimate the impact of a 6-week daily intake of 2000 mg of ginger extract on the
      composition of the gut microbiome using a randomized placebo-controlled double-blinded
      design, i.e. examine the change of microbiome over time within and between the subjects.

      Aim 2 will examine the correlation between the ginger-related changes in microbiome profile
      with the levels of circulating biomarkers: urinary Prostaglandin E (PGE) metabolites.

      Hypothesis: In the ginger versus placebo arm, gut microbiome will shift towards a lower
      proportion of pro-inflammatory, bacteria associated with colorectal cancer (CRC) and higher
      proportion of anti-inflammatory, CRC-protective bacteria.

      Secondary Aim:

        1. At the end of the study, we expect to show that ginger decreases the relative abundance
           of pro-inflammatory, CRC-predisposing taxa and increases the abundance of
           anti-inflammatory, CRC-protective taxa, i.e., demonstrate that ginger boosts changes in
           gut microbiome that are protective against CRC, as well as assess ginger-induced changes
           in immune response.

        2. The similarities of bacterial profiles will be compared between three time points
           baseline and 6 Weeks and 12 Weeks to estimate whether 6-week is a sufficient time for
           washout.
    

Intervention name(s): Ginger extract; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 2000 mg ginger extract daily for 6 weeks, plus 6 weeks washout; 2000 mg ginger extract daily for 6 weeks, plus 6 weeks washout
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Pilot. Double-blind placebo-controlled randomized trial
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: gingerol; microbiome; gut; ginger