Colonization and Persistence of Bifidobacterium Longum

NCT01650753 | Completed

• 1 other identifier: UNL 222-12 FB
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Bacterium; Agent

Outcome Measures

Primary Outcomes (1)

• Persistence or presence of the probiotic strain Bifidobacterium Longum ssp longum AH1206.

  16 weeks

Study Arms (2)

Probiotic Powder

EXPERIMENTAL

Probiotic: Bifidobacterium longum subsp longum AH1206

Dietary Supplement: Probiotic Powder

Placebo Powder

PLACEBO COMPARATOR

Equivalent amount (same volume) of maltodextrin

Dietary Supplement: Placebo powder

Interventions

Probiotic Powder DIETARY_SUPPLEMENT

Bifidobacterium longum subsp longum AH1206 freeze dried and provided as a powder in a sachet (10\^10 cells/sachet)

Probiotic Powder

Placebo powder DIETARY_SUPPLEMENT

powdered maltodextrin inthe same volume and the freeze dried probiotic in a similar size sachet

Placebo Powder

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nebraska Lincoln: lead

Study Officials

• Jens Walter, PhD

  University of Nebraska Lincoln

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD: Department of Food Science and Technology

Study Record Dates

• First Submitted: July 23, 2012
• First Posted: July 26, 2012
• Study Start: August 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: November 1, 2015
• Last Updated: November 6, 2015

Record last verified: 2015-11