- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04735809
Efficacy of a Whole Cell Algae Fermentate on Gut Health and Overall Immune Function in Healthy Adults With Mild Gastrointestinal Issues
A Randomized, Double-blind, Placebo-controlled, Crossover Study to Assess the Efficacy of a Patented Whole Cell Algae Fermentate on Gut Health in Healthy Adults With Mild Gastrointestinal Issues
Study Overview
Status
Intervention / Treatment
Detailed Description
This study is a randomized, placebo-controlled, crossover trial with a screening visit and two test periods separated by a three-week washout period.
At Visit 1, after subjects have provided informed consent, medical history will be reviewed and clinic visit procedures will be performed, including assessments of prior/current medication/supplement use, and evaluations of inclusion/exclusion criteria.Subjects will be dispensed a diet record, gastrointestinal questionnaire, bowel habits diary, upper respiratory symptom questionnaire, and a stool collection kit to complete prior to Visit 2 (week 0).
At Visit 2 (week 0), eligible subjects will return to the clinic. The stool samples will be collected, and the diet record, gastrointestinal questionnaire, and bowel habits diary will be collected. Subjects will also be administered a stress questionnaire and quality of life questionnaire. Eligible subjects will then be randomized to one of two test groups (placebo or active). Subjects will track study product intake using a daily study product log and track daily cold symptoms. Subjects will also be given a gastrointestinal questionnaire, bowel habits diary, upper respiratory symptom questionnaire, and a stool collection kit to complete prior to Visit 3 (week 4).
At Visit 3 (week 4), the stool samples will be collected, and the diet record, gastrointestinal questionnaire, and bowel habits diary will be collected. Subjects will also be administered a stress and quality of life questionnaire. Unused study product will be collected and compliance assessed via unused study product.Subjects will also be given a gastrointestinal questionnaire, bowel habits diary, and a stool collection kit to complete prior to Visit 4 (week 7)
Subjects will then enter the 3-week washout period, during which time no surveys/questionnaires will be kept and will then crossover to the other study product in their test sequence and repeat the Test Period I procedures (at Visit 2 and 3) during Test Period II (Visits 4 [week 7] and 5 [week 11]).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Illinois
-
Addison, Illinois, United States, 60101
- Biofortis Innovation Services
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subject is a male or female, 21-60 years of age
- Subject has a BMI of 18.5-34.9 kg/m2
- Subject reports having mild GI issues
- Subject is willing and able to comply with the collection and storage requirements of the stool samples
- Subject has internet access via computer, phone or other device and is able to maintain internet access throughout the trial in order to complete online daily questionnaires
- Subject is a non-user of all tobacco, smoking products and nicotine products
- Subject is willing to maintain physical activity patterns, body weight, supplements/medications, sleep patterns, and habitual diet throughout the trial.
- Subject has no health conditions that would prevent him from fulfilling the study requirements 9 Subject understands the study procedures and signs forms providing informed consent to participate in the study
Exclusion Criteria:
- Subject has an abnormal laboratory test result(s) of clinical importance at Visit 1
- Subject has a clinically important GI condition that would potentially interfere with the evaluation of the study product
- Subject has a history or presence of uncontrolled and/or clinically important pulmonary (including uncontrolled asthma), cardiac (including, but not limited to, atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke), hepatic, renal, endocrine (including type 1 and type 2 diabetes mellitus), hematologic, immunologic, neurologic (such as Alzheimer's or Parkinson's disease), psychiatric (including unstable depression and/or unstable anxiety disorders) or biliary disorders
- Subject has a known allergy, intolerance, or sensitivity to any of the ingredients in the study products
- Subject has extreme dietary habits (e.g., Atkins diet, very high protein, very high fiber)
- Subject has uncontrolled hypertension
- Subject has a recent (within 6 weeks of Visit 1) diarrhea (defined as ≥3 loose or liquid stools/d)
- Subject has participated in colonoscopy or colonoscopy preparation within 3 months prior to Visit 1
- Subject has a history or presence of cancer in the prior two years, except for non-melanoma skin cancer
- Subject has a history of bariatric surgery for weight reducing purposes
- Subject has had a weight gain or loss of ≥5% body weight within 6 months of Visit 1
- Subject has experienced any major trauma or any other surgical event within three months of Visit 1
- Subject has any signs or symptoms of an active infection (including diarrhea) of clinical relevance within 5 days of Visit 1
- Subject has used antibiotics within 3 months of Visit 1 or throughout study period
- Subject has used medications (over-the-counter or prescription) or dietary supplements known to influence GI function
- Subject has used medications or supplements known to influence immune responses
- Subject is a regular user (>3 times/week) of prescribed anti-inflammatory medications within 30 d of Visit 1
- Subject is a regular user (i.e., >1 time per month) of allergy medications
- Subject has used weight-loss medications
- Subject is a female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period
- Subject has a recent history of (within 12 months of screening; Visit 1; week -1) or strong potential for alcohol or substance abuse
- Individual has a condition the Clinical Investigator believes would interfere with his ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results, or put the subject at undue risk
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Microcystalline Cellulose
|
microcrystalline cellulose
|
Experimental: Treatment
Whole Cell Algae Fermentate
|
Contains at minimum 50% Beta Glucan
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gastrointestinal symptom
Time Frame: After 4 weeks of each test period
|
Gastrointestinal Tolerability Questionnaire
|
After 4 weeks of each test period
|
Gastrointestinal ease and consistency
Time Frame: After 4 weeks of each test period
|
Bristol Stool Scale
|
After 4 weeks of each test period
|
Cold/Flu Symptoms
Time Frame: After 4 weeks of each test period
|
Wisconsin Upper Respiratory Symptom Survey
|
After 4 weeks of each test period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fecal Microbiome
Time Frame: After 4 weeks of each test period
|
Omnigene-GUT DNA Genotek
|
After 4 weeks of each test period
|
Fecal biomarker 1
Time Frame: After 4 weeks of each test period
|
Short Chain Fatty Acid
|
After 4 weeks of each test period
|
Fecal biomarker 2
Time Frame: After 4 weeks of each test period
|
Leaky Gut biomarker
|
After 4 weeks of each test period
|
Stress Questionnaire
Time Frame: After 4 weeks of each test period
|
Perceived Stress Questionnaire
|
After 4 weeks of each test period
|
Quality of Life Questionnaire
Time Frame: After 4 weeks of each test period
|
World Health Organization-Quality of Life Questionnaire
|
After 4 weeks of each test period
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Andrea Lawless, MD, Biofortis Innovation Services
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- BIO-1901
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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