Fructanase for Digestive Health

Overseen By John Marshall

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: BIO-CAT, Inc.

Must not be taking: Antibiotics, Steroids, Anti-inflammatories, others

Disqualifiers: GI conditions, Diabetes, Cancer, others

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

Trial Summary

What is the purpose of this trial?

The carbohydrate inulin (from chicory root) is a healthy prebiotic ingredient found in dietary supplements and fortified foods (Nagy et al). Inulin is representative of a broader class of typically health-associated, yet fermentable carbohydrates called fructans that occur naturally in many vegetables, fruits, and wheat. Fructans, or long chains of fructose units, are resistant to human digestive enzyme hydrolysis and transit intact to the small intestine and colon where they undergo rapid fermentation by intestinal microbes. This microbial metabolism of fructans produces gas and other fermentation byproducts that can lead to excess gastrointestinal (GI) symptoms like abdominal bloating, cramping, stomach rumbling, and flatulence (Bonnema et al; Briet et al; Bruhwyler et al), especially in individuals with irritable bowel syndrome (Van den Houte et al). A new digestive enzyme called fructanase was developed to help with GI symptoms associated with fructan consumption. Positive findings from in vitro digestion simulations (Guice et al) and a first-in-human safety trial (Garvey et al) helped define the fructanase dose for this clinical trial-the primary objective of which is to investigate the effect of oral fructanase administration on GI symptoms in healthy adults after consuming oatmeal with added inulin (25 grams). Secondary outcomes include breath hydrogen and methane levels, which serve as biomarkers of intestinal microbial fermentation. The investigators hypothesize that fructanase administration will lower the severity of GI symptoms after inulin consumption, as well as lower breath biomarkers of intestinal microbial fermentation, compared to placebo.

Research Team

Aditi M. Shaw, MD

Principal Investigator

Biofortis, Inc.

Eligibility Criteria

This trial is for healthy adults aged 20-50 with a BMI of 18.5 to less than 30, who don't use tobacco or nicotine and can maintain their usual diet and weight during the study. They must not have health issues that could interfere with the trial, avoid certain medications and supplements, and give informed consent.

Inclusion Criteria

BMI ≥18.5 to less than 30.0 kg/m2 at Visit 1 (Day -7)

I am between 20 and 50 years old.

Willing to maintain habitual diet, physical activity, and body weight throughout the trial

Exclusion Criteria

Known sensitivity, intolerability, or allergy to any of the study products or their excipients

I do not have a severe GI condition that could affect the study's treatment evaluation.

Extreme dietary habits at the discretion of the Clinical Investigator

Treatment Details

Interventions

• Fructanase

Trial Overview The trial tests if fructanase, a new digestive enzyme, can reduce gastrointestinal symptoms like bloating and gas after eating inulin-enriched oatmeal compared to a placebo (maltodextrin). It also measures breath hydrogen and methane as indicators of gut fermentation.

Participant Groups

Group I: Fructanase Active Control 1 Intervention

Total 400 inulinase activity units (INU) per dose

Group II: Placebo Placebo Group 1 Intervention

Maltodextrin

Who Is Running the Clinical Trial?

BIO-CAT, Inc.

Lead Sponsor

Trials

6

Recruited

210+

Biofortis, Inc.

Collaborator

Trials

1

Recruited

30+