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PHAGE Study: Bacteriophages as Novel Prebiotics

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: NCT03269617
Recruitment Status : Completed
First Posted : September 1, 2017
Last Update Posted : April 4, 2019
Sponsor:
Collaborators:
George Mason University
Metabiomics Corp
Information provided by (Responsible Party):
Tiffany Weir, Colorado State University

Brief Summary:
The PHAGE study is designed to determine if a commercial prebiotic product can change the composition of bacteria in the gut for improved intestinal health. A prebiotic is defined as an indigestible dietary component that selectively enhances specific bacterial species in the intestines to confer a health benefit. In this study, the prebiotic a unique combination of bacteriophages, or viruses that infect bacteria. These phages are generally regarded as safe for human consumption and work by infecting bad bacteria in the gut, which allows beneficial bacteria populations to increase. The product, PreforPro, has shown to be effective in culture-based and animal studies, but its efficacy has not been demonstrated in humans. The goal of this study is to see if PreforPro consumption improves gut bacteria profiles in individuals relative to a placebo control and is associated with reduced incidence and severity of gastrointestinal distress.

Condition or disease Intervention/treatment Phase
Gastrointestinal Disorder, Functional Dietary Supplement: Bacteriophage mixture Other: Placebo Control Not Applicable

Detailed Description:
The goal of this study is to see if consumption of PreforPro, a commercially available prebiotic dietary supplement consisting of a mixture of bacteriophages, improves gut bacteria profiles in individuals relative to a placebo control. Secondary outcome measures include determining changes in comprehensive metabolic profiles, inflammatory markers (systemic and local), microbial metabolites, and perceptions of gastrointestinal distress. To accomplish these research goals, 40 male and female volunteers between 18-65 years old with BMI scores of 20 to 34.9 who suffer from mild gastrointestinal distress will be enrolled.Recruitment will be by referral from local practitioners and through email solicitations. Eligibility will be determined at the Colorado State University Medical Nutrition Therapy Laboratory (MNTL) by a screening questionnaire and interview/assessment by the clinical coordinator. After determining eligibility and securing consent, participants will randomly be assigned to 1 of 2 treatment groups: prebiotic or placebo. Participants will consume one capsule daily of respective treatments for a period of four (4) weeks. At the beginning and end of the 4 week treatment periods blood and stool samples will be collected at the Human Performance Clinical Research Laboratory (HPCRL). This means that participants will make a total of four (4) clinic visits during each treatment period. Following the initial treatment period, all participants will be required to undergo a wash-out period for two (2) weeks. Upon completion of the wash-out period, participants will switch treatment groups for a period of four (4) weeks. Clinic visits at baseline and 4-weeks for collection of stool and blood samples will also be conducted during the second treatment period. Study participants will be required to provide a total of four (4) fecal samples and four (4) fasting blood samples. Additionally, study participants will be required to provide a weekly assessment of GI symptoms during the two treatment periods. All blood samples will be collected at Colorado State University by trained professionals. Fecal sample collection will be performed by the study participant with collection materials provided by study personnel. Both participants and researchers will be blinded during the course of the intervention and throughout the data analysis period. Blinding will be conducted by individuals from Deerland Enzymes, the company that is providing the capsules for intervention.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: The PHAGE Study is a randomized, double-blind, placebo controlled crossover trial that investigates the utility of four supplemental bacteriophage strains (LH01-Myoviridae, LL5-Siphoviridae, T4D-Myoviridae, and LL12-Myoviridae) to modulate the gut microbiota, and therefore ameliorate common inflammation-related GI distress symptoms (e.g., gas, bloating, diarrhea, constipation, etc) experienced by healthy individuals.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Samples were provided in coded bottles whose identity is known only to the product manufacturer. Blinding will persist until all samples have been processed and the data statistically analyzed.
Primary Purpose: Basic Science
Official Title: PreforPro: A Randomized, Placebo Controlled Crossover Study
Actual Study Start Date : October 1, 2016
Actual Primary Completion Date : May 30, 2017
Actual Study Completion Date : May 30, 2017

Arm Intervention/treatment
Placebo Comparator: Placebo Comparator
Placebo control: 1 capsule containing rice maltodextrin consumed 1x daily for 28 days.
Other: Placebo Control
Placebo control capsule consisting of rice maltodextrin
Other Name: rice maltodextrin

Experimental: Experimental
Bacteriophage mixture: 1 capsule containing rice maltodextrin and a mixture of 4 bacteriophages consumed 1x daily for 28 days.
Dietary Supplement: Bacteriophage mixture
Four bacteriophage strains: LH01-Myoviridae, LL5-Siphoviridae, T4D-Myoviridae, and LL12-Myoviridae.
Other Name: PreforPro




Primary Outcome Measures :
  1. Microbiota modulation [ Time Frame: Baseline visit prior to starting treatments,4 weeks after starting treatment 1, end of 2-week washout period, 4-weeks after starting treatment 2 ]
    Use of 16s rRNA sequencing of stool samples to determine whether the administered interventions resulted in changes to microbial composition.


Secondary Outcome Measures :
  1. Local inflammation [ Time Frame: Baseline visit prior to starting treatments,4 weeks after starting treatment 1, end of 2-week washout period, 4-weeks after starting treatment 2 ]
    Inflammation in the bowels will be assessed by use of ELISA test for fecal calprotectin.

  2. Systemic Inflammation [ Time Frame: Baseline visit prior to starting treatments,4 weeks after starting treatment 1, end of 2-week washout period, 4-weeks after starting treatment 2 ]
    Systemic inflammation will be assessed by an ELISA test for CRP and circulating cytokines and immune factors.


Other Outcome Measures:
  1. Microbial metabolism [ Time Frame: Baseline visit prior to starting treatments,4 weeks after starting treatment 1, end of 2-week washout period, 4-weeks after starting treatment 2 ]
    Fermentation by microbes in the gut will be assessed by measuring fecal short chain fatty acid concentrations.

  2. Circulating lipids [ Time Frame: Baseline visit prior to starting treatments,4 weeks after starting treatment 1, end of 2-week washout period, 4-weeks after starting treatment 2 ]
    Total cholesterol, LDL, HDL, and triglycerides will be determined in venous blood using a clinical analyzer (Piccolo Xpress).

  3. Comprehensive metabolic panel [ Time Frame: Baseline visit prior to starting treatments,4 weeks after starting treatment 1, end of 2-week washout period, 4-weeks after starting treatment 2 ]
    Basic metabolic parameters such as fasting glucose, and levels of BUN, creatinine, and liver enzymes will be determined from a single 200 ul aliquot of venous blood using a CMP clinical analysis panel for Piccolo Xpress.

  4. GI symptom self-assessment [ Time Frame: Baseline visit prior to starting treatments,4 weeks after starting treatment 1, end of 2-week washout period, 4-weeks after starting treatment 2 ]
    Participants will complete a validated questionnaire to track changes in GI symptoms.



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.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy adults
  • 18-65 years old
  • Mild to moderate GI distress (self-assessed)

Exclusion Criteria:

  • Pregnant or breastfeeding
  • Diagnosed GI disease (Celiac, peptic ulcer, ulcerative colitis, Crohn's disease, cancer, or other gastrointestinal or metabolic diseases)
  • Antibiotic use in the past 2 months
  • Use of NSAIDS, statins, metformin, and other drugs known to modify the gut microbiota
  • BMI less than 18.0 or greater than 35.0

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): NCT03269617


Sponsors and Collaborators
Colorado State University
George Mason University
Metabiomics Corp
Investigators
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Principal Investigator: Tiffany Weir, PhD Colorado State University

Publications of Results:
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Responsible Party: Tiffany Weir, Associate Professor, Colorado State University
ClinicalTrials.gov Identifier: NCT03269617    
Other Study ID Numbers: 16-6666HH
First Posted: September 1, 2017    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tiffany Weir, Colorado State University:
dysbiosis
gut microbiota
bacteriophage
irritable bowel syndrome
gastrointestinal distress
prebiotic
Additional relevant MeSH terms:
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Gastrointestinal Diseases
Digestive System Diseases