Recruiting

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

Sponsor:

Nutrition 21, Inc.

Code:

NCT01464814

Conditions

Signs and Symptoms, Digestive

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Accepted

Interventions

probiotic plus fish oil capsule

Fish oil capsule

Study Details

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) health in healthy adults.

Conditions

Signs and Symptoms, Digestive

Study ID

NCT01464814

Start date

Oct, 2011

Status verified date

Nov, 2011

Completion date

Nov, 2011

Anticipated

Primary completion date

Nov, 2011

Anticipated

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

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 Criteria:

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.

Study Design

Enrollment

15 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Probiotic

Lactobacillus casei in fish oil capsule

placebo comparator: Placebo

Fish oil capsule

Interventions

probiotic plus fish oil capsule

Lactobacillus casei (4B CFU) plus fish oil capsule, T.I.D., for seven (7) days.

Fish oil capsule

Fish oil capsule, T.I.D., for seven (7) days

Primary outcome measure

Fecal probiotic (KE-99) level [ Time Frame: Fecal samples collected at baseline and after 7 days of treatment, during each treatment arm. ]

Central Contacts and Locations

Central contacts

Samantha Feldman, MS, RD

305-722-0970 sfeldman@miamiresearch.com

Locations

Broward Research Group

Recruiting

Pembroke Pines, Florida, United States, 33026

Contacts

Samantha Feldman, MS, RD

305-722-0970 sfeldman@miamiresearch.com

More Information

Sponsor

Nutrition 21, Inc.

Last update posted

Nov 16, 2011

Last verified

Nov, 2011

Keywords

probiotic
fish oil
digestion
viability

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Nutrition 21, Inc. on 2011-11-16.