Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Colonization and Persistence of Bifidobacterium Longum

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.
 
ClinicalTrials.gov Identifier: NCT01650753
Recruitment Status : Completed
First Posted : July 26, 2012
Last Update Posted : November 6, 2015
Sponsor:
Information provided by (Responsible Party):
Jens Walter, University of Nebraska Lincoln

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Healthy adults referred to as the absence of intestinal disorders, liver and kidney problems, lactose intolerance, and no use of ongoing medication for chronic diseases will be recruited. This research study will test the persistence of the probiotic (healthy bacterial) strain Bifidobacterium longum spp. longum in the human gastrointestinal tract after it is consumed, how it is tolerated, and its interactions with other micro-organisms already present in your gastrointestinal tract. The strain used is similar to bacteria used in probiotic yogurts, and the species Bifidobacterium is generally regarded as safe. The patient will be asked to will be consume a probiotic powder containing Bifidobacterium longum spp. longum strain AH1206 and a placebo in a random order, with neither the patient nor the investigators knowing the identity of the preparations given. Persistence or presence of the probiotic strain will be based on analysis of fecal (stool or bowel movement) samples provided.

Condition or disease Intervention/treatment Phase
Bacterium; Agent Dietary Supplement: Probiotic Powder Dietary Supplement: Placebo powder Not Applicable

Detailed Description:

The study will be performed as a 14 week randomized crossover trial with two treatments, one of which is the placebo. The randomization design will be provided by collaborators at Mead Johnson, and the study will be performed double blinded, such that no study staff will be informed about the nature of the product. Each treatment period will consist of a one week baseline period, in which one fecal sample will be collected. This will be followed by a two week feeding period in which the probiotic will be administered at a constant dose of 10^10 cells per day in 50 to 100 ml of either cold or room temperature tab water. At day 7 and 14 (last day of feeding), a fecal sample will be collected. The last sample during feeding will also serve as day 0 of Test of Persistence (TOP) period. Persistence of the probiotic strains will be tested during the TOP period at day 4, 8, 16, and 28 (4 weeks) for a total of 7 fecal samples. The subjects will then crossover to the other treatment and the above fecal sample collections will be repeated. Fecal samples will be provided by the subjects using disposable stool collection containers not longer than 2 hours after defecation. In the lab fecal samples will be stored undiluted (four aliquots) and as 1/10 dilutions in PBS buffer (four aliquots). The investigators will also prepare five tubes with 1 gram aliquots of each fecal sample and will provide these samples de-identified to Mead Johnson Nutrition for future analyses. Experimental design. Fecal samples will be studied by qRT-PCR. Fecal samples may be subjected to pyrosequencing and selective culturing.

All subjects will fill out a Gastrointestinal Symptom Rating Scale (GSRS) questionnaire (at week GSRS at week 1, 2, 3, 4 and 8, 9, 10 11) to test the acceptance and safety of the strain, and to test if subjects remain eligible for the study. Weeks 1 and 8 are the baseline visits, weeks 4 and 11 are one week after subject stops taking study product. Subjects that have begun or expect to begin antibiotic treatment or that have experienced unacceptable side effects will stop their participation.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: Quantitative Evaluation of the Colonization and Persistence of Bifidobacterium Longum Ssp Longum AH1206 in the Gastrointestinal Tract and Its Tolerance by Human Subjects
Study Start Date : August 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : November 2015
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Probiotic Powder
Probiotic: Bifidobacterium longum subsp longum AH1206
 Dietary Supplement: Probiotic Powder
Bifidobacterium longum subsp longum AH1206 freeze dried and provided as a powder in a sachet (10^10 cells/sachet)
Placebo Comparator: Placebo Powder
Equivalent amount (same volume) of maltodextrin
 Dietary Supplement: Placebo powder
powdered maltodextrin inthe same volume and the freeze dried probiotic in a similar size sachet


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Persistence or presence of the probiotic strain Bifidobacterium Longum ssp longum AH1206. [ Time Frame: 16 weeks ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Able to give written informed consent and willingness to participate in the study and comply with its procedures.
  • Male or Female
  • Aged 19 years of age and over.
  • Be in generally good health as determined by the investigators. BMI of 18.5-29.9 kg/m2
  • Free of any gastrointestinal disorders or complaints, as determined by the Bowel Disease Questionnaire (Talley et al., 1990), at visit 1.
  • Not pregnant and not lactating.
  • Be able to provide fecal samples for the duration of the 14 week study.
  • Be willing to complete the Gastrointestinal Symptom Rating Scale (GSRS) once a week.

Exclusion Criteria:

  • Less than 19 years of age.
  • Underweighted or obese based on BMI.
  • Antibiotic usage 3 months prior to study or during study.
  • Significant acute or chronic existing illness [cardiovascular, gastrointestinal, immunological] or a condition which in the investigators judgment, contraindicates involvement in the study.
  • Prior gastrointestinal surgery (apart from appendicectomy and hernia repair) or recent unexplained bleeding which, in the Investigator's judgment, contraindicates participation in the study.
  • Having a condition or taking a medication, dietary supplement or food product (e.g. probiotic yogurt) that the investigator believes would interfere with the objectives of the study, pose a safety risk or confound the interpretation of the study results.
  • Individuals who, in the opinion of the investigator, are considered to be poor clinical attendees or unlikely for any reason to be able to comply with the trial.
  • Patients receiving treatment involving experimental drugs.
  • Pregnant or lactating.
  • Participation in a recent experimental trial less than 30 days prior to this study.
  • Have a malignant disease or any concomitant end-stage organ disease, which, in the Investigator's judgment, contraindicates participation in the study.
  • Inability to provide fecal samples for the duration of the 14 week study.
  • Inability to complete the weekly GSRS.se on antibiotics, suppressed immune systems
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ClinicalTrials.gov identifier (NCT number): NCT01650753


Sponsors and Collaborators
University of Nebraska Lincoln
Investigators
Layout table for investigator information
Principal Investigator: Jens Walter, PhD University of Nebraska Lincoln
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Jens Walter, PhD: Department of Food Science and Technology, University of Nebraska Lincoln
ClinicalTrials.gov Identifier: NCT01650753    
Other Study ID Numbers: UNL 222-12 FB
First Posted: July 26, 2012    Key Record Dates
Last Update Posted: November 6, 2015
Last Verified: November 2015