Clinical Trial Evaluating the Viability of L. Casei + Fish Oil Capsules

Status unconfirmed · Not applicable · Has a placebo group

Conditions studied: Signs and Symptoms, Digestive

In brief

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) health in healthy adults.

Key facts

Study ID

NCT01464814

Run by

Nutrition 21, Inc.

People needed

15

Starts

2011-10-01

Expected to finish

2011-11-01

Last updated by the study team

2011-11-16

Who can join

Age: 21 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Broward Research Group — Pembroke Pines, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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