Status:
COMPLETED
A Study on Intestinal Gas Symptoms to Evaluate the Effects of Gas Defense in Otherwise Healthy Adult
Lead Sponsor:
Miami Research Associates
Collaborating Sponsors:
Ganeden Biotech, Inc.
Conditions:
Abdominal Pain
Abdominal Cramps
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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 appro...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT00881322
Start Date
June 1 2008
End Date
September 1 2008
Last Update
September 30 2009
Active Locations (2)
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1
Miami Research Associates
Miami, Florida, United States, 33143
2
Latin American Research
Santo Domingo, Dominican Republic