A Prospective, Randomized, Double-Blind, Placebo-Controlled Parallel-Group Clinical Trial to Evaluate the Effects of Gas Defense On Intestinal Gas Symptoms in Otherwise Healthy Adults
A Prospective, Randomized, Double-Blind, Placebo-Controlled Parallel-Group Clinical Trial to Evaluate the Effects of Gas Defense On Intestinal Gas Symptoms in Otherwise Healthy Adults
This is a randomized, double-blind, placebo-controlled trial to determine the safety and efficacy of Digestive Advantage™ Gas Defense formula, a probiotic dietary supplement. The study will last approximately four weeks, and subjects will be seen at a screening/randomization visit, and two follow-up visits.
Study procedures will include administering questionnaires for assessment of the study product's effect on intestinal gas symptoms and quality of life.
Inclusion Criteria:
Exclusion Criteria:
Subject has any of the following medical conditions:
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.