A Study on Intestinal Gas Symptoms to Evaluate the Effects of Gas Defense in Otherwise Healthy Adult

Exclusion Criteria

• •Subject has any of the following medical conditions:
• •* 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.