Ignite Creation Date:
2024-05-06 @ 6:41 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05744700
Status:
COMPLETED
Last Update Posted:
2023-10-10
First Post:
2023-02-16
Brief Title:
Safety and Tolerability Trial of Microbial Inulinase
Sponsor:
BIO-CAT Inc
Organization:
BIO-CAT Inc
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Clinical Trial to Determine the Safety and Tolerability of Microbial Inulinase
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objectives of this clinical trial are to 1 assess the effect of microbial inulinase on gastrointestinal symptoms in healthy participants compared to a placebo and 2 to assess the safety and tolerability of microbial inulinase in healthy participants compared to a placebo
Detailed Description:
Dietary FODMAPs fermentable oligosaccharides disaccharides monosaccharides and polyols can be digestively bothersome for certain fiber-intolerant individuals as well as those with irritable bowel syndrome Dionne et al Oral supplementation of microbial enzymes is a promising strategy to ameliorate gastrointestinal GI symptoms-such as bloating abdominal discomfort and gas-that are associated with food intolerances Oral enzyme supplementation with fungal beta-galactosidase lactase fungal alpha-galactosidase and a mixture of microbial and plant proteases have previously been clinically shown to effectively reduce GI symptoms associated with dairy legume and gluten consumption respectively Lin et al Di Stefano et al Ido et al While alpha-galactosidase effectively hydrolyzes galactan-type FODMAPs there remains a need to target fructan-type FODMAPs Preclinical data using an in vitro static GI digestion model showed that the microbial enzyme inulinase can effectively digest fructan-rich substrates eg inulin from chicory root garlic and a high-fructan meal mash better than control conditions under simulated gastric conditions Guice et al submitted
The present study is a randomized double-blind placebo-controlled clinical trial to determine the safety and tolerability of microbial inulinase as a digestive enzyme supplement in healthy adults This clinical trial will include 60 participants who are healthy adults between the ages of 20 to 60 and who regularly consume at least two meals daily The study duration will be up to 62 days This trial consists of one screening visit Visit 1 Day -30 to -15 a baseline visit Visit 2 Day 1 and an end-of-study visit Visit 3 Day 29 3
To assess the effect of inulinase on GI-related symptoms participants will fill out the paper Gastrointestinal Symptom Rating Scale GSRS on a weekly basis over the course of the study The GSRS is a validated questionnaire containing 15 questions used to assess symptoms that are commonly associated with GI disorders Machnicki et al All 15 questions are rated using a 7-point Likert scale where higher ratings represent more discomfort The GSRS score is determined by the score of five subscales reflux diarrhea abdominal Pain indigestion and constipation The reflux score will be calculated as an average score of questions 2 and 3 The diarrhea score will be calculated as an average score of questions 1112 and 14 The abdominal pain score will be calculated as an average score of questions 1 4 and 5 The indigestion score will be calculated as an average score of questions 6 7 8 and 9 The constipation score will be calculated as an average score of questions 10 13 and 15 Each subscale score is the domain score The average of all 5 domain scores will give the GSRS score The GSRS score and 5 sub-scale domain scores will be used for analysis The scores in Visit 2 will be treated as baseline and change from baseline to Week 1 Week 2 Week 3 and Week 4 will be calculated as well as the proportion of participants showing improved scores
At screening Visit 1 up to 30 days and no less than 15 days prior to the baseline visit participants will arrive at the clinic in a fasting state 10 hours After participants provide voluntary informed consent the following information will be recorded and procedures carried out
Collect demographic data age sex ethnicity and race
Review medicalhealth history
Reviewrecord dietary and lifestyle habits
Reviewrecord use of concomitant treatments
Review inclusionexclusion criteria
Take anthropometric measurements height screening only weight and vital signs heart rate HR and blood pressure BP
Calculate body mass index BMI kgm2
Perform a brief symptom-based physical exam if necessary
Collect blood for hematology clinical chemistry lipid profile and hemoglobin A1c HbA1c
Dispense GSRS questionnaire for in-clinic completion
Dispense GSRS questionnaire for at-home use
Dispense study product placebo only and study diary
After confirming eligibility from Day -14 to Day -1 the day prior to baseline visit on Day 1 all participants will complete a 2-week run-in period where they will orally consume the placebo capsule twice daily with their usual two largest meals of the day one capsule per meal with the same two meals each day
At baseline Visit 2 Day 1 participants will arrive at the clinic in a fasting state 10 hours The following visit procedures will occur
Collect and review any unused study product
Review the study diary to assess compliance concomitant treatments medical conditions and changes in health
Review inclusionexclusion criteria
Review medicalhealth history
Review any changes in dietary and lifestyle habits
Take anthropometric measurements and vital signs HR and BP
Calculate BMI using height collected from screening
Collect blood for hematology clinical chemistry and lipid profiling
Collect blood for lactate insulin uric acid and high sensitivity C-reactive protein hsCRP
Collect urine for pregnancy test
Collect the GSRS questionnaire completed during the run-in period
Dispense GSRS questionnaire for the participant to complete in-clinic
Dispense GSRS questionnaire for at-home use
Randomize the participant to inulinase or placebo
Dose of study product in-clinic
Adverse Event AE monitoring
Dispense study products and study diary for home use by the participant
At the baseline visit on Day 1 participants will be randomized in a 11 ratio to either study product 1000 units of inulinase activity INU per serving or placebo and then start the 28 3 days of twice daily study product consumption Study product will be taken in the same manner 1 capsule taken twice daily with their two usual larger meals of the day
At end-of-study Visit 3 Day 29 3 participants will arrive at the clinic in a fasting state 10 hours The following visit procedures will occur
Return any unused study product and packaging of used study product
Collect and review the study diary to assess compliance
Review any changes in dietary and lifestyle habits
Measure vital signs BP and HR and weight and calculate BMI
Collect urine for pregnancy test
Collect blood for hematology clinical chemistry and lipid profiling
Collect blood for lactate insulin uric acid and hsCRP
Collect the GSRS questionnaire and review for completion
Dispense GSRS questionnaire for the participant to complete in-clinic
AE monitoring
The present study is a randomized double-blind placebo-controlled clinical trial to determine the safety and tolerability of microbial inulinase as a digestive enzyme supplement in healthy adults This clinical trial will include 60 participants who are healthy adults between the ages of 20 to 60 and who regularly consume at least two meals daily The study duration will be up to 62 days This trial consists of one screening visit Visit 1 Day -30 to -15 a baseline visit Visit 2 Day 1 and an end-of-study visit Visit 3 Day 29 3
To assess the effect of inulinase on GI-related symptoms participants will fill out the paper Gastrointestinal Symptom Rating Scale GSRS on a weekly basis over the course of the study The GSRS is a validated questionnaire containing 15 questions used to assess symptoms that are commonly associated with GI disorders Machnicki et al All 15 questions are rated using a 7-point Likert scale where higher ratings represent more discomfort The GSRS score is determined by the score of five subscales reflux diarrhea abdominal Pain indigestion and constipation The reflux score will be calculated as an average score of questions 2 and 3 The diarrhea score will be calculated as an average score of questions 1112 and 14 The abdominal pain score will be calculated as an average score of questions 1 4 and 5 The indigestion score will be calculated as an average score of questions 6 7 8 and 9 The constipation score will be calculated as an average score of questions 10 13 and 15 Each subscale score is the domain score The average of all 5 domain scores will give the GSRS score The GSRS score and 5 sub-scale domain scores will be used for analysis The scores in Visit 2 will be treated as baseline and change from baseline to Week 1 Week 2 Week 3 and Week 4 will be calculated as well as the proportion of participants showing improved scores
At screening Visit 1 up to 30 days and no less than 15 days prior to the baseline visit participants will arrive at the clinic in a fasting state 10 hours After participants provide voluntary informed consent the following information will be recorded and procedures carried out
Collect demographic data age sex ethnicity and race
Review medicalhealth history
Reviewrecord dietary and lifestyle habits
Reviewrecord use of concomitant treatments
Review inclusionexclusion criteria
Take anthropometric measurements height screening only weight and vital signs heart rate HR and blood pressure BP
Calculate body mass index BMI kgm2
Perform a brief symptom-based physical exam if necessary
Collect blood for hematology clinical chemistry lipid profile and hemoglobin A1c HbA1c
Dispense GSRS questionnaire for in-clinic completion
Dispense GSRS questionnaire for at-home use
Dispense study product placebo only and study diary
After confirming eligibility from Day -14 to Day -1 the day prior to baseline visit on Day 1 all participants will complete a 2-week run-in period where they will orally consume the placebo capsule twice daily with their usual two largest meals of the day one capsule per meal with the same two meals each day
At baseline Visit 2 Day 1 participants will arrive at the clinic in a fasting state 10 hours The following visit procedures will occur
Collect and review any unused study product
Review the study diary to assess compliance concomitant treatments medical conditions and changes in health
Review inclusionexclusion criteria
Review medicalhealth history
Review any changes in dietary and lifestyle habits
Take anthropometric measurements and vital signs HR and BP
Calculate BMI using height collected from screening
Collect blood for hematology clinical chemistry and lipid profiling
Collect blood for lactate insulin uric acid and high sensitivity C-reactive protein hsCRP
Collect urine for pregnancy test
Collect the GSRS questionnaire completed during the run-in period
Dispense GSRS questionnaire for the participant to complete in-clinic
Dispense GSRS questionnaire for at-home use
Randomize the participant to inulinase or placebo
Dose of study product in-clinic
Adverse Event AE monitoring
Dispense study products and study diary for home use by the participant
At the baseline visit on Day 1 participants will be randomized in a 11 ratio to either study product 1000 units of inulinase activity INU per serving or placebo and then start the 28 3 days of twice daily study product consumption Study product will be taken in the same manner 1 capsule taken twice daily with their two usual larger meals of the day
At end-of-study Visit 3 Day 29 3 participants will arrive at the clinic in a fasting state 10 hours The following visit procedures will occur
Return any unused study product and packaging of used study product
Collect and review the study diary to assess compliance
Review any changes in dietary and lifestyle habits
Measure vital signs BP and HR and weight and calculate BMI
Collect urine for pregnancy test
Collect blood for hematology clinical chemistry and lipid profiling
Collect blood for lactate insulin uric acid and hsCRP
Collect the GSRS questionnaire and review for completion
Dispense GSRS questionnaire for the participant to complete in-clinic
AE monitoring
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| BCCT-AB-0009 | OTHER | BIO-CAT Inc | None |