Clinical Evaluation of the Effects of EpiCor on Digestive Comfort

Summary

Previous in vitro studies suggest that EpiCor is well fermented in the colon and has prebiotic potential. The repeated long-term administration of low doses of EpiCor in the Simulator of the Human Intestinal Microbial Ecosystem (SHIME) has shown that this product is able to induce gradual changes in the colonic environment by: i) being selectively fermented, leading to butyrate increase in the colon; ii) stimulating Lactobacilli growth in the lumen and adherence to the mucosal surface, and iii) decreasing potential pathogens. In addition, the fermentation-derived metabolites produced in the colon were shown to potentially benefit the host by decreasing cytokine levels in vitro. As a result, the investigators hypothesize that EpiCor may help to improve bowel function and generally contribute to enhanced gut health. Therefore, this pilot study is intended to assess the effects of long-term administration of EpiCor on a population with mild symptoms of intestinal dysfunction.

The primary objective of this exploratory pilot study is to assess the effect of long term administration of EpiCor on bowel function and gastrointestinal well-being, by means of validated questionnaires.

This study has 4 secondary objectives: 1) The first secondary objective of this study is to assess the protective effects of EpiCor on intestinal barrier function, by performing a gut sugar permeability test in combination with indomethacin challenge; 2) The second secondary objective is to assess the effects of EpiCor on intestinal barrier function, by measuring blood Zonulin and endotoxin levels in combination with indomethacin challenge; 3) The third secondary objective of this study is to assess the prebiotic properties of EpiCor by collecting fecal samples. The microbial community composition, lactate and SCFA profiles and proteolytic activity markers in feces will be determined. Proteolytic activity markers will also be measured in urine samples; 4) The fourth secondary objective of this study is to assess the effects of EpiCor on local and systemic immune system performance by measuring secretory IgA levels in feces and cytokines in blood.

Conditions

• Constipation
• Gastrointestinal Discomfort

Interventions

DIETARY_SUPPLEMENT

Placebo

The participants will be asked to orally ingest one capsule per day (500 mg maltodextrin, single serving), in combination with 200mL water.

DIETARY_SUPPLEMENT

EpiCor

The participants will be asked to orally ingest one capsule per day (500 mg EpiCor, single serving), in combination with 200mL water.

Sponsors & Collaborators

• University Ghent

  collaborator OTHER

• Maastricht University

  collaborator OTHER

• Embria Health Sciences

  collaborator UNKNOWN

• ProDigest

  lead INDUSTRY

Principal Investigators

• Iris Pinheiro, PhD · ProDigest

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2015-07-06

Primary Completion

2016-01-31

Completion

2016-11-30