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.


Eligibility Criteria:
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.