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Enzyme

Fructanase for Digestive Health

N/A
Recruiting
Led By Aditi M. Shaw, MD
Research Sponsored by BIO-CAT, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female, age ≥20 to ≤50 years at Visit 1 (Day -7)
Non-user (never used, or former user defined as cessation ≥12 months) of tobacco or nicotine products with no plans to begin use during the study period
Must not have
Clinically important GI condition that would potentially interfere with the evaluation of the study product
Uncontrolled hypertension
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours

Summary

"This trial is investigating the effects of a new digestive enzyme called fructanase on gastrointestinal symptoms in healthy adults after consuming oatmeal with added inulin. Fructan is a type of carbohydrate found

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects are not detailed in the provided information but may include typical digestive discomforts due to enzyme activity or reactions to inulin such as bloating or gas.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 20 and 50 years old.
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I haven't used tobacco or nicotine in the last year and don't plan to start.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have a severe GI condition that could affect the study's treatment evaluation.
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My blood pressure is not controlled by medication.
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I do not have any uncontrolled major health issues.
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I tested positive for COVID-19 and have had symptoms for over 2 months.
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I haven't had any cancer except for non-melanoma skin cancer in the last 2 years.
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I have not had major surgery or trauma in the last 3 months.
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I have not had symptoms of a significant infection in the last 5 days.
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My weight has changed by more than 4.5 kg in the last 3 months.
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I haven't taken antibiotics in the last 3 months and won't during the study.
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I haven't used steroids in the last month and won't use them during the study.
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I have used marijuana, hemp, or CBD products in the last 30 days.
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I have been taking anti-inflammatory medications regularly for the last month.
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I haven't taken meds or supplements that affect my stomach function in the last 2 weeks.
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I haven't taken any experimental drugs in the last 4 weeks.
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I am not pregnant, planning to become pregnant, or breastfeeding, and I agree to use contraception during the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Maximum postprandial baseline-adjusted overall abdominal symptoms severity over the 8-hour in-clinic period
Secondary study objectives
Breath combined hydrogen and methane Cmax (ppm)
Breath combined hydrogen and methane Tmax (min)
Breath combined hydrogen and methane concentration AUC (ppm × min)
+16 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: FructanaseActive Control1 Intervention
Total 400 inulinase activity units (INU) per dose
Group II: PlaceboPlacebo Group1 Intervention
Maltodextrin

Find a Location

Who is running the clinical trial?

Biofortis, Inc.UNKNOWN
BIO-CAT, Inc.Lead Sponsor
5 Previous Clinical Trials
177 Total Patients Enrolled
3 Trials studying Gastrointestinal Health
114 Patients Enrolled for Gastrointestinal Health
Aditi M. Shaw, MDPrincipal InvestigatorBiofortis, Inc.
~20 spots leftby Jan 2025
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