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Enzyme
Inulinase for Digestive Health
N/A
Waitlist Available
Led By Anthony Bier, MD, CCFP
Research Sponsored by BIO-CAT Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights
Study Summary
This trial will assess if inulinase, a microbial enzyme, can improve gut health & safety in healthy people vs. a placebo. #ClinicalTrial
Eligible Conditions
- Digestive Health
- Gastrointestinal Health
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Abdominal discomfort, bloating, and burping scores
Blood pressure
Body mass index
+44 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: InulinaseActive Control1 Intervention
Total 2,000 INU inulinase per day for 28 days
Group II: PlaceboPlacebo Group1 Intervention
Maltodextrin for 28 days
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Who is running the clinical trial?
BIO-CAT Inc.Lead Sponsor
3 Previous Clinical Trials
93 Total Patients Enrolled
1 Trials studying Digestive Health
30 Patients Enrolled for Digestive Health
BIO-CAT, Inc.Lead Sponsor
4 Previous Clinical Trials
117 Total Patients Enrolled
2 Trials studying Digestive Health
54 Patients Enrolled for Digestive Health
Nutrasource Pharmaceutical and Nutraceutical Services, Inc.NETWORK
32 Previous Clinical Trials
1,853 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You had a recent episode of stomach illness with symptoms like feeling sick, throwing up, or having loose stools within the past two weeks.You have a history of certain digestive disorders like irritable bowel syndrome, inflammatory bowel disease, or eating disorders. You have also had surgery on your intestines or stomach, except for appendix or hernia surgeries.You have a history of heart disease, high blood pressure that is not well controlled, kidney disease requiring dialysis or due to kidney failure, or liver problems.You are okay with continuing to use cannabinoids (if you are currently using them) during the study.You have a very unique and different diet from most people, such as the ketogenic diet, Atkins diet, low FODMAP diet, vegetarian diet, or fruitarian diet.You have had problems with your liver, gallbladder, or stomach ulcers in the past.You have a history of thyroid disease that is not stable, a major mood disorder that was diagnosed before, a psychiatric disorder that required hospitalization within the past year, or immune disorders or weakened immune system.You have had issues with alcohol or drug abuse, including marijuana, within the past year, and may have needed to go to the hospital or a treatment program for it.You agree to drink no more than 3-4 alcoholic drinks per day during the study.
Research Study Groups:
This trial has the following groups:- Group 1: Inulinase
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is eligibility for this trial limited to individuals aged 65 and under?
"To be eligible for inclusion in this clinical trial, patients must not exceed 60 years old and must have reached the age of majority."
Answered by AI
Does this experiment have any current openings?
"According to clinicaltrials.gov, this medical research program is no longer recruiting participants as of February 24th 2023; the initial posting was on March 6th 2023. Despite its status, two other studies are actively seeking out patients at this time."
Answered by AI
Are there specific criteria for individuals to be considered eligible participants in this clinical trial?
"Eligibility for this medical study is restricted to individuals aged 30-60 who are dealing with digestive issues. In total, about 60 participants will be accepted."
Answered by AI
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