A Study on Intestinal Gas Symptoms to Evaluate the Effects of Gas Defense in Otherwise Healthy Adult
NCT ID: NCT00881322
Last Updated: 2009-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
61 participants
INTERVENTIONAL
2008-06-30
2008-09-30
Brief Summary
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Study procedures will include administering questionnaires for assessment of the study product's effect on intestinal gas symptoms and quality of life.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DOUBLE
Study Groups
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BC-130
Active Arm
BC-130 (Gas Defense)
Product Dosing:
Take one capsule daily, at approximately the same time of day, without regard to food (may be taken with or without food)
Gas Defense Serving Size: 1 tablet Active Ingredients: B. Coagulans, Enzyme Blend (Cellulase - Trichoderma longibrachiatum, Cellulase - Aspergillus niger, Hemicellulase, Alpha Galactosidase, Invertase) Inactive Ingredients: vegetable capsule, Magnesium Stearate, Silicon Dioxide, Maltodextrin Contains: Wheat, Fish.
Sugar Pill
Placebo
Placebo
Product Dosing:
Take one capsule daily, at approximately the same time of day, without regard to food (may be taken with or without food)
Placebo - matched in size and color to the active product Inactive Ingredients: microcrystalline cellulose, FD\&C yellow #5 Lake, FD\&C blue #1 Lake, FD\&C red #46 Lake and vegetable capsule
Interventions
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BC-130 (Gas Defense)
Product Dosing:
Take one capsule daily, at approximately the same time of day, without regard to food (may be taken with or without food)
Gas Defense Serving Size: 1 tablet Active Ingredients: B. Coagulans, Enzyme Blend (Cellulase - Trichoderma longibrachiatum, Cellulase - Aspergillus niger, Hemicellulase, Alpha Galactosidase, Invertase) Inactive Ingredients: vegetable capsule, Magnesium Stearate, Silicon Dioxide, Maltodextrin Contains: Wheat, Fish.
Placebo
Product Dosing:
Take one capsule daily, at approximately the same time of day, without regard to food (may be taken with or without food)
Placebo - matched in size and color to the active product Inactive Ingredients: microcrystalline cellulose, FD\&C yellow #5 Lake, FD\&C blue #1 Lake, FD\&C red #46 Lake and vegetable capsule
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject self-reports at least one of the following symptoms after eating a meal or snack:
* Abdominal pain/cramps
* Distended feeling/bloating
* Flatulence/gas
* Subject is in otherwise general good health as determined by physical exam and medical history.
* Subject is willing and able to comply with the protocol.
* Female subjects not defined as post-menopausal (excluding hysterectomized and post bilateral tubal ligations) must use a reliable method of birth control as defined within this protocol.
* Subject is able to understand and sign the informed consent (English or Spanish) to participate in the study.
Exclusion Criteria
* active heart disease
* renal or hepatic impairment/disease
* Type I or II diabetes
* psychiatric disorders (hospitalized within the past one year)
* bipolar disorder
* Parkinson's disease
* unstable thyroid disease
* immune disorder (such as HIV/AIDS)
* any medical condition deemed exclusionary by the Principal Investigator (PI)
* Subject has a history of cancer (except localized skin cancer without metastases or in situ cervical cancer) within five years prior to screening.
* Subject has had any stomach or intestinal surgery (i.e. gastric bypass).
* Subject is currently taking antibiotics (or any drug that significantly interferes with bacterial flora) or has taken antibiotics within the 30 days prior to screening/enrollment.
* Subject is currently taking or has used in the past 30 days probiotics or prebiotics.
* Subject is on an unstable dose of medication (defined as fewer than 90 days at the same dose).
* Subject is currently taking any medication deemed exclusionary by PI.
* Subject has a history of or currently has any gastrointestinal disorders or inflammatory bowel conditions such as Crohn's disease, short bowel, or ulcerative colitis. Subjects may not have a diagnosis, be seeing a doctor, or taking prescription medication(s) for Irritable Bowel Syndrome (IBS).
* Subject has constipation defined as less than three spontaneous bowel movements per week.
* Subject is lactose intolerant (self-professed or diagnosed).
* Subject uses any of the following classification of GI medications two or more times per week: anti-spasmodics, motility agents, pro-kinetic agents or laxatives.
* Subject plans to use another over-the-counter gas-relief product daily during the study period. Over-the-counter gas relief products may be used as rescue medication (their use will be captured by the study staff). If a subject is using a fiber supplement prior to starting the study, he/she may continue as long as the frequency and quantity remain stable throughout the study period.
* Subject has an allergy to wheat or fish or any of the other product ingredients (see section 2.5.4).
* Subject has two or more food allergies.
* Subject has a history of drug or alcohol abuse within the past 12 months.
* Subject is deemed by the Investigator as an unsuitable candidate for receipt of an investigational dietary supplement, or unable to be followed up throughout the entire duration of the study.
* Female subject of childbearing potential is unwilling to use an acceptable form of contraceptive device throughout the study period.
* Subject is pregnant, lactating, or planning to become pregnant during the study period.
* Subject is participating in another clinical trial or has received an investigational product within 30 days prior to screening/enrollment.
* Subject is deemed by the Investigator as an unsuitable candidate for receipt of an investigational dietary supplement, or unable to be followed up throughout the entire duration of the study.
* Subject is unable to comprehend the Informed Consent and research purpose.
* Subject is unable or unwilling to comply with the protocol.
18 Years
75 Years
ALL
Yes
Sponsors
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Ganeden Biotech, Inc.
INDUSTRY
Miami Research Associates
NETWORK
Responsible Party
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Miami Research Associates
Principal Investigators
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Diane Krieger, MD
Role: PRINCIPAL_INVESTIGATOR
Medical Director
Locations
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Miami Research Associates
Miami, Florida, United States
Latin American Research
Santo Domingo, , Dominican Republic
Countries
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References
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Kalman DS, Schwartz HI, Alvarez P, Feldman S, Pezzullo JC, Krieger DR. A prospective, randomized, double-blind, placebo-controlled parallel-group dual site trial to evaluate the effects of a Bacillus coagulans-based product on functional intestinal gas symptoms. BMC Gastroenterol. 2009 Nov 18;9:85. doi: 10.1186/1471-230X-9-85.
Other Identifiers
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GAN-2008
Identifier Type: -
Identifier Source: org_study_id