Trials Sponsors Conditions Drugs Pricing

Conditions

Signs and Symptoms, Digestive

Keywords

probioticfish oildigestionviability

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 capsuleDietary supplement

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

Also known as: Probiomega

Probiotic

Fish oil capsuleDietary supplement

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

Also known as:

Eligibility Criteria

Age21 Years - 75 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (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

Sponsors & Collaborators

Nutrition 21, Inc.
Industrylead

Study Sites (1)

Broward Research Group

Pembroke Pines, Florida, 33026, United States

RECRUITING

Samantha Feldman, MS, RDCONTACT305-722-0970 ext. 3311 sfeldman@miamiresearch.com

MeSH Terms

Conditions

Signs and Symptoms, Digestive

Interventions

ProbioticsFish Oils

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesOilsLipids

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 2011

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

November 2011

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.
+1 more criteria

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

Primary Completion

Study Completion

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (2)

Probiotic

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

Primary Completion

Study Completion

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (2)

Probiotic

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations