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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01464814
Recruitment Status : Unknown
Verified November 2011 by Nutrition 21, Inc..
Recruitment status was:  Recruiting
First Posted : November 4, 2011
Last Update Posted : November 16, 2011
Information provided by (Responsible Party):
Nutrition 21, Inc.

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.

Condition or disease Intervention/treatment Phase
Signs and Symptoms, Digestive Dietary Supplement: probiotic plus fish oil capsule Dietary Supplement: Fish oil capsule Not Applicable

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 gastrointestinal (GI) health. The study will last approximately three weeks with subjects attending a screening visit and four follow-up visits.

The study will involve subjects taking the probiotic product (KE-99 + fish oil)and placebo, each for seven days (as per sponsor guidance), in random order, with a seven day washout in between (as per sponsor guidance). Fecal analyses will be done at the beginning and end of each seven day supplementation period so that the number of live KE-99 in feces can be determined with higher numbers being positive (indicates more live KE-99 survived digestion).

Although the study population will be comprised of generally healthy adults that do not have GI disorders or symptoms, the sponsor hypothesizes that there may be beneficial effects in GI health with the KE-99 + fish oil supplementation. A six item questionnaire will be used to assess changes in GI health (e.g. abdominal pain, bloating and gas) with lower incidence indicating positive effects with regard to GI health.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Double Blind Placebo Controlled Crossover Clinical Trial Evaluating The Viability Of KE-99 With Fish Oil In Healthy Adults
Study Start Date : October 2011
Estimated Primary Completion Date : November 2011
Estimated Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Fish oil
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Probiotic
Lactobacillus casei in fish oil capsule
Dietary Supplement: probiotic plus fish oil capsule
Lactobacillus casei (4B CFU) plus fish oil capsule, T.I.D., for seven (7) days.
Other Name: Probiomega
Placebo Comparator: Placebo
Fish oil capsule
Dietary Supplement: Fish oil capsule
Fish oil capsule, T.I.D., for seven (7) days
Other Name: Placebo

Primary Outcome Measures :
  1. Fecal probiotic (KE-99) level [ Time Frame: Fecal samples collected at baseline and after 7 days of treatment, during each treatment arm. ]
    KE-99 probiotic levels will be measured from fecal samples at baseline and compared to levels measured after 7 days of treatment to determine if live KE-99 bacteria survive transit through the gastrointestinal tract.

Secondary Outcome Measures :
  1. SF-36v2 [ Time Frame: At baseline and after 7 days of each treatment arm. ]
    SF-36v2 - is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. Results will be compared between and within groups.

  2. GI questionnaire [ Time Frame: At baseline and after 7 days of each treatment arm. ]
    GI Questionnaire - a six-part questionnaire regarding general well-being and gastrointestinal symptoms will be administered, with results being compared between and within groups.

  3. Tolerability Questionnaire [ Time Frame: After 7 days of each treatment arm. ]
    Tolerability of the study products will be assessed at the end of each seven-day supplementation period (at visits 3 and 5).

  4. qPCR Fecal Microbiota Analyses [ Time Frame: Measuerd at baseline (Day 0) and after 7 days, of each treatment arm. ]
    Reverse transcription-quantitative PCR (RT-qPCR) will be performed at baseline (Day 0) and after 7 days of treatment, to compare human intestinal microbiota after treatment to baseline.

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01464814

Contact: Samantha Feldman, MS, RD 305-722-0970 ext 3311

United States, Florida
Broward Research Group Recruiting
Pembroke Pines, Florida, United States, 33026
Contact: Samantha Feldman, MS, RD    305-722-0970 ext 3311   
Sponsors and Collaborators
Nutrition 21, Inc.
Principal Investigator: David Seiden, MD Broward Research Group

Responsible Party: Nutrition 21, Inc. Identifier: NCT01464814     History of Changes
Other Study ID Numbers: N21-2011
First Posted: November 4, 2011    Key Record Dates
Last Update Posted: November 16, 2011
Last Verified: November 2011

Keywords provided by Nutrition 21, Inc.:
fish oil

Additional relevant MeSH terms:
Signs and Symptoms
Signs and Symptoms, Digestive