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

NCT01464814 | Unknown

• 1 other identifier: N21-2011
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Keywords

probiotic; fish oil; digestion; viability

Outcome Measures

Primary Outcomes (1)

• Fecal probiotic (KE-99) level

  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.

  Fecal samples collected at baseline and after 7 days of treatment, during each treatment arm.

Secondary Outcomes (4)

• SF-36v2

  At baseline and after 7 days of each treatment arm.

• GI questionnaire

  At baseline and after 7 days of each treatment arm.

• Tolerability Questionnaire

  After 7 days of each treatment arm.

• qPCR Fecal Microbiota Analyses

  Measuerd at baseline (Day 0) and after 7 days, of each treatment arm.

Study Arms (2)

Probiotic

EXPERIMENTAL

Lactobacillus casei in fish oil capsule

Dietary Supplement: probiotic plus fish oil capsule

Placebo

PLACEBO COMPARATOR

Fish oil capsule

Dietary Supplement: Fish oil capsule

Interventions

probiotic plus fish oil capsule DIETARY_SUPPLEMENT

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

Also known as: Probiomega

Probiotic

Fish oil capsule DIETARY_SUPPLEMENT

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

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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 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 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.

Sponsors & Collaborators

• Nutrition 21, Inc.: lead

Study Sites (1)

Broward Research Group

Pembroke Pines, Florida, 33026, United States

RECRUITING

MeSH Terms

Conditions

Signs and Symptoms, Digestive

Interventions

Probiotics; Fish Oils

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Oils; Lipids

Study Officials

• David Seiden, MD

  Broward Research Group

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samantha Feldman, MS, RD

CONTACT

305-722-0970; sfeldman@miamiresearch.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2011
• First Posted: November 4, 2011
• Study Start: October 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: November 16, 2011

Record last verified: 2011-11

Locations

US (1)