Status:
UNKNOWN
Clinical Trial Evaluating the Viability of L. Casei + Fish Oil Capsules
Lead Sponsor:
Nutrition 21, Inc.
Conditions:
Signs and Symptoms, Digestive
Eligibility:
All Genders
21-75 years
Phase:
NA
Brief Summary
The purpose of this study is to determine the effects of the probiotic KE-99 Lactobacillus casei when administered with omega-3 fish oil on probiotic viability, fecal make-up and gastrointestinal (GI)...
Detailed Description
This is a randomized, placebo controlled, crossover clinical trial to determine the effects of KE-99 Lactobacillus casei with omega-3 fish oil, a probiotic purported to promote beneficial effects in g...
Eligibility Criteria
Inclusion
- Female subject is surgically sterile, post-menopausal or agrees to use an acceptable method of birth control
- Subject is able to understand and sign the informed consent to participate in the study
- Subject is willing and able to comply with the protocol including:a. Attending five visits; b. Collecting four stool samples; c. Refraining from eating any yogurt or lacto-fermented beverages during the study; d. Refraining from using any dietary supplements including probiotics or prebiotics during the study;e. Not taking any new vitamin and/or mineral supplements until after study completion.
Exclusion
- Subject has any of the following medical conditions: a. active heart disease, b. uncontrolled high blood pressure (≥ 140/90 mmHg), c. renal or hepatic impairment/disease, d. Type I or II diabetes, e. bipolar disorder f. Parkinson's disease, g. unstable thyroid disease, h. immune disorder (such as HIV/AIDS), i. psychiatric disorders (hospitalized within the past one year), j. 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 a history of or currently has any gastrointestinal disease or disorder or any inflammatory bowel condition such as Crohn's disease, short bowel,ulcerative colitis, or 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 has had any stomach or intestinal surgery (i.e. gastric bypass).
- Subject takes on a regular basis (defined as two or more times per week) any prescription or over-the counter medications for diarrhea, constipation, heartburn or any other gastrointestinal problems.
- Subject is currently taking laxatives or has taken laxatives within the 30 days prior to screening/enrollment.
- Subject is currently taking antibiotics (or any drug that significantly interferes with bacterial flora) or has taken antibiotics within the 60 days prior to screening/enrollment.
- Subject is currently taking or has used in the past 30 days probiotics (including yogurt and lacto-fermented beverages), prebiotic supplements, or any digestive enzymes \[prescription or over-the-counter (OTC)\]. Thirty-day washout allowed.
- Subject is on an unstable dose of medication (defined as fewer than 90 days at the same dose).
- Anti-hypertensives and anti-hyperlipidemic medications ok if stable dose.
- Subject is currently taking any medication deemed exclusionary by PI.
- Subject exhibits evidence of hepatic or renal dysfunction as evidenced by ALT, AST, AP being ≥ two times the upper limit of normal or serum creatinine value ≥ 2.0 mg/dl or other clinically significant abnormal clinical laboratory value per PI discretion.
- Subject has an allergy to fish or any of the ingredients in the test product (see section 3.2.1).
- Subject has a history of drug or alcohol abuse in the past 12 months.
- Subject has any condition or abnormality that, in the opinion of the investigator, would compromise the safety of the subject or the quality of the study data.
- Subject is participating or has participated in another research study within 30 days prior to the screening visit.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2011
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01464814
Start Date
October 1 2011
End Date
November 1 2011
Last Update
November 16 2011
Active Locations (1)
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1
Broward Research Group
Pembroke Pines, Florida, United States, 33026