Signs and Symptoms, DigestiveProbiomegaNCT01464814
Clinical Trial Evaluating the Viability of L. Casei + Fish Oil Capsules
A study testing probiotic plus fish oil capsule and Fish oil capsule in people with Signs and Symptoms, Digestive, run by Nutrition 21, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Signs and Symptoms, Digestive
- What is being tested?
- probiotic plus fish oil capsule and Fish oil capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Nov 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 18Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Broward Research Group
Pembroke Pines, Florida, 33026
Samantha Feldman, MS, RD, 305-722-0970 ext. 3311, sfeldman@miamiresearch.com
About this study
Official title: A Double Blind Placebo Controlled Crossover Clinical Trial Evaluating The Viability Of KE-99 With Fish Oil In Healthy Adults
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.
Read the 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.
- Conditions
- Signs and Symptoms, Digestive
- Being tested
- probiotic plus fish oil capsule, Fish oil capsule
- Keywords
- probiotic, fish oil, digestion, viability
- Medical subject headings
- Signs and Symptoms, Digestive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
probiotic plus fish oil capsuleDietary supplement
Also called Probiomega
Lactobacillus casei (4B CFU) plus fish oil capsule, T.I.D., for seven (7) days.
Fish oil capsuleDietary supplement
Also called Placebo
Fish oil capsule, T.I.D., for seven (7) days
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | Lactobacillus casei in fish oil capsule Receives: Dietary Supplement: probiotic plus fish oil capsule |
| Placebo | Placebo comparator | Fish oil capsule Receives: Dietary Supplement: Fish oil capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Fecal samples collected at baseline and after 7 days of treatment, during each treatment arm.
Secondary outcomes (4)
SF-36v2
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.
Measured: At baseline and after 7 days of each treatment arm.
GI questionnaire
GI Questionnaire - a six-part questionnaire regarding general well-being and gastrointestinal symptoms will be administered, with results being compared between and within groups.
Measured: At baseline and after 7 days of each treatment arm.
Tolerability Questionnaire
Tolerability of the study products will be assessed at the end of each seven-day supplementation period (at visits 3 and 5).
Measured: After 7 days of each treatment arm.
qPCR Fecal Microbiota Analyses
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.
Measured: Measuerd at baseline (Day 0) and after 7 days, of each treatment arm.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2011 (estimated)
- Study startOct 2011
- Primary completionNov 2011 (estimated)
- Study completionNov 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Signs and Symptoms, DigestiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nutrition 21, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Seiden, MD, Principal investigator, Broward Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01464814
- Sponsor's protocol ID
- N21-2011
- Acronym
- Probiomega
- Status last verified
- Nov 2011
- First submitted
- 4 Oct 2011
- Last updated
- 16 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind Placebo Controlled Crossover Clinical Trial Evaluating The Viability Of KE-99 With Fish Oil In Healthy Adults
- ClinicalTrials.gov ID
- NCT01464814
- Acronym / sponsor ID
- Probiomega / N21-2011
- Conditions
- Signs and Symptoms, Digestive
- Keywords
- probiotic, fish oil, digestion, viability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Nutrition 21, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Nov 2011 (estimated)
- Study completion
- Nov 2011 (estimated)
- First posted
- 4 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Dietary Supplement: probiotic plus fish oil capsuleLactobacillus casei in fish oil capsule |
| Placebo | Placebo comparator | Dietary Supplement: Fish oil capsuleFish oil capsule |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (18 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| probiotic plus fish oil capsuleAlso: ProbiomegaLactobacillus casei (4B CFU) plus fish oil capsule, T.I.D., for seven (7) days. | Dietary supplement | Probiotic |
| Fish oil capsuleAlso: PlaceboFish oil capsule, T.I.D., for seven (7) days | Dietary supplement | Placebo |
Primary outcome
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.
4 secondary outcomes
SF-36v2
Time frame: At baseline and after 7 days of each treatment arm.
GI questionnaire
Time frame: At baseline and after 7 days of each treatment arm.
Tolerability Questionnaire
Time frame: After 7 days of each treatment arm.
qPCR Fecal Microbiota Analyses
Time frame: Measuerd at baseline (Day 0) and after 7 days, of each treatment arm.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Seiden, MD principal investigator
Broward Research Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing probiotic plus fish oil capsule and Fish oil capsule in people with Signs and Symptoms, Digestive, run by Nutrition 21, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samantha Feldman, MS, RD (305-722-0970 ext. 3311, sfeldman@miamiresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2011.