PHAGE Study: Bacteriophages as Novel Prebiotics

NCT03269617 | Completed

• 1 other identifier: 16-6666HH
• Study Type: interventional
• Target: 43
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gastrointestinal Disorder, Functional

Keywords

dysbiosis; gut microbiota; bacteriophage; irritable bowel syndrome; gastrointestinal distress; prebiotic

Outcome Measures

Primary Outcomes (1)

• Microbiota modulation

  Use of 16s rRNA sequencing of stool samples to determine whether the administered interventions resulted in changes to microbial composition.

  Baseline visit prior to starting treatments,4 weeks after starting treatment 1, end of 2-week washout period, 4-weeks after starting treatment 2

Secondary Outcomes (2)

• Local inflammation

  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

  Baseline visit prior to starting treatments,4 weeks after starting treatment 1, end of 2-week washout period, 4-weeks after starting treatment 2

Other Outcomes (4)

• Microbial metabolism

  Baseline visit prior to starting treatments,4 weeks after starting treatment 1, end of 2-week washout period, 4-weeks after starting treatment 2

• Circulating lipids

  Baseline visit prior to starting treatments,4 weeks after starting treatment 1, end of 2-week washout period, 4-weeks after starting treatment 2

• Comprehensive metabolic panel

  Baseline visit prior to starting treatments,4 weeks after starting treatment 1, end of 2-week washout period, 4-weeks after starting treatment 2

Study Arms (2)

Placebo Comparator

PLACEBO COMPARATOR

Placebo control: 1 capsule containing rice maltodextrin consumed 1x daily for 28 days.

Other: Placebo Control

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

Interventions

Bacteriophage mixture DIETARY_SUPPLEMENT

Four bacteriophage strains: LH01-Myoviridae, LL5-Siphoviridae, T4D-Myoviridae, and LL12-Myoviridae.

Also known as: PreforPro

Experimental

Placebo Control OTHER

Placebo control capsule consisting of rice maltodextrin

Also known as: rice maltodextrin

Placebo Comparator

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Colorado State University: lead
• George Mason University: collaborator
• Metabiomics Corp: collaborator

Related Publications (2)

• Febvre HP, Rao S, Gindin M, Goodwin NDM, Finer E, Vivanco JS, Lu S, Manter DK, Wallace TC, Weir TL. PHAGE Study: Effects of Supplemental Bacteriophage Intake on Inflammation and Gut Microbiota in Healthy Adults. Nutrients. 2019 Mar 20;11(3):666. doi: 10.3390/nu11030666.

  PMID: 30897686 RESULT

• Gindin M, Febvre HP, Rao S, Wallace TC, Weir TL. Bacteriophage for Gastrointestinal Health (PHAGE) Study: Evaluating the Safety and Tolerability of Supplemental Bacteriophage Consumption. J Am Coll Nutr. 2019 Jan;38(1):68-75. doi: 10.1080/07315724.2018.1483783. Epub 2018 Aug 29.

  PMID: 30157383 RESULT

MeSH Terms

Conditions

Gastrointestinal Diseases; Dysbiosis; Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases

Study Officials

• Tiffany Weir, PhD

  Colorado State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: August 1, 2017
• First Posted: September 1, 2017
• Study Start: October 1, 2016
• Primary Completion: May 30, 2017
• Study Completion: May 30, 2017
• Last Updated: April 4, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share