a study on intestinal gas symptoms to evaluate the effects of gas defense in otherwise healthy adult

Conditions: Abdominal Pain; Abdominal Cramps; Flatulence

Summary: 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.