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

Inclusion criteria

• Subject is 18-75 years of age.
• 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

• 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.