Ginger and Gut Microbiome (GINGER)

Colorectal Adenoma Clinical Trial

Official title:

Pilot Trial to Examine the Effect of Ginger on the Gut Microbiome (GINGER)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03268655
• Other study ID #: SPH-2017-25928
• Secondary ID: Anna-CPRC-TBD
• Status: Completed
• Phase: N/A
• Start date: November 14, 2018
• Est. completion date: June 26, 2020

Study information

• Verified date: July 2020
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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..

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: June 26, 2020
• Est. primary completion date: June 26, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

Inclusion Criteria:

• Colorectal adenoma diagnosis

Exclusion Criteria:

• Allergy or sensitivity to ginger

• Active cancer

• Unstable medical condition

• Unstable diet or weight

Related Conditions & MeSH terms

• Adenoma
• Colorectal Adenoma

Intervention

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

Locations

Country	Name	City	State
United States	Mayo Clinic Cancer Center	Albert Lea	Minnesota
United States	Mayo Clinic Cancer Center	Austin	Minnesota
United States	Essentia Health - Deer River	Deer River	Minnesota
United States	Essentia Health St Mary's - Detroit Lakes	Detroit Lakes	Minnesota
United States	Essentia Health - Fosston Clinic	Fosston	Minnesota
United States	Fairview Grand Itasca Clinic & Hospital	Grand Rapids	Minnesota
United States	Fairview Range Medical Center	Hibbing	Minnesota
United States	Mayo Clinic Cancer System	Mankato	Minnesota
United States	Epidemiology Clinical Research Center	Minneapolis	Minnesota
United States	Monticello Cancer Center	Monticello	Minnesota
United States	Essentia Health - Park Rapids Clinic	Park Rapids	Minnesota
United States	Fairview Northland Medical Center	Princeton	Minnesota
United States	Essentia Health -Virgina Clinic	Virginia	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composition of the gut microbiome	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).	Baseline to 6 Weeks
Primary	Urine inflammatory biomarker	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	Baseline to 6 weeks
Secondary	Change in gut microbiome composition	Beta-diversity will be compared between three time points: baseline, 6 Weeks and 12 Weeks.	Baseline to 12 weeks