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Ginger and Gut Microbiome (GINGER)

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ClinicalTrials.gov Identifier: NCT03268655
Recruitment Status : Active, not recruiting
First Posted : August 31, 2017
Last Update Posted : June 26, 2020
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Tracking Information
First Submitted Date  ICMJE August 25, 2017
First Posted Date  ICMJE August 31, 2017
Last Update Posted Date June 26, 2020
Actual Study Start Date  ICMJE November 14, 2018
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2018)
  • Composition of the gut microbiome [ Time Frame: Baseline to 6 Weeks ]
    Fecal microbial diversity and the prevalence of specific taxa associated with colorectal cancer (e.g. Fusobacteria, butyrate producing bacteria) will be estimated at 6 weeks. The ginger-related changes in the prevalence of each taxon will be assessed individually and also combined into a microbiome index (the abundance of protective taxa will be included as a negative value).
  • Urine inflammatory biomarker [ Time Frame: Baseline to 6 weeks ]
    Urinary metabolite of Prostaglandin E2 (ng/mg of creatinine) will be measured before and after treatment with ginger. Changes in inflammatory markers will be correlated to changes in the microbial diversity and the microbiome composition
Original Primary Outcome Measures  ICMJE
 (submitted: August 29, 2017)
Gut microbiome [ Time Frame: 3 times within 12 weeks ]
16S RNA genetic sequencing will be conducted
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2018)
Change in gut microbiome composition [ Time Frame: Baseline to 12 weeks ]
Beta-diversity will be compared between three time points: baseline, 6 Weeks and 12 Weeks.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ginger and Gut Microbiome (GINGER)
Official Title  ICMJE Pilot Trial to Examine the Effect of Ginger on the Gut Microbiome (GINGER)
Brief 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Pilot. Double-blind placebo-controlled randomized trial
Masking: Double (Participant, Investigator)
Masking Description:
Double blind
Primary Purpose: Basic Science
Condition  ICMJE Colorectal Adenoma
Intervention  ICMJE
  • Dietary Supplement: Ginger extract
    2000 mg ginger extract daily for 6 weeks, plus 6 weeks washout
  • Other: Placebo
    2000 mg ginger extract daily for 6 weeks, plus 6 weeks washout
Study Arms  ICMJE
  • Experimental: Ginger extract
    Ginger extract, 2000 mg daily for 6 weeks, followed by 6 week washout.
    Intervention: Dietary Supplement: Ginger extract
  • Experimental: Placebo
    Placebo, daily for 6 weeks, followed by 6 week washout.
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: March 20, 2020)
68
Original Estimated Enrollment  ICMJE
 (submitted: August 29, 2017)
20
Estimated Study Completion Date  ICMJE September 2020
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Colorectal adenoma diagnosis

Exclusion Criteria:

  • Allergy or sensitivity to ginger
  • Active cancer
  • Unstable medical condition
  • Unstable diet or weight
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03268655
Other Study ID Numbers  ICMJE SPH-2017-25928
Anna-CPRC-TBD ( Other Identifier: UMN Clinical Protocol Review Committee )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: The results of the study will be disseminated to various stakeholders through the publication of a manuscript in a peer-reviewed journal and through presentation at scientific meetings.
Responsible Party University of Minnesota
Study Sponsor  ICMJE University of Minnesota
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Anna Prizment, PhD, MPH University of Minnesota, Epidemiology and Community Health
PRS Account University of Minnesota
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP