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

 -  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.