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

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.

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.