Phage 3Determination of Phage/Probiotic Synergistic Effects on Gastrointestinal Health

NCT05750433 | Completed

• 1 other identifier: 1676
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this double blinded clinical trial is to determine whether consumption of the PreforPro product, when co-consumed with Bacillus subtilis DE111 probiotic, synergistically improves bowel regularity, perceived physical symptoms of gastrointestinal distress and other aspects of gastrointestinal health over probiotic use alone. Therefore, the primary goal of this study is to see if PreforPro consumption concurrent with B. subtilis DE111 usage improves probiotic activity. The secondary goal of this study is to assess non-gastrointestinal physiologic parameters to determine whether consumption of PreforPro combined with the probiotic offers any additional health benefits (ie. reduced inflammation, improved gut microbiota profiles) beyond those of consuming a probiotic alone. Participants will be asked to track daily bowel movements for 7 days prior to beginning capsule consumption and record their diet for a total 3 of days (two weekdays and one weekend day). They will then be asked to consume the provided capsules daily for a period of 45 days. Researchers will compare three parallel arms; (1) PreforPro+B. subtilis DE111 probiotic, (2) B. subtilis DE111 alone, or (3) a maltodextrin placebo to establish their impact on gastrointestinal symptoms and other indicators of health.

Conditions

Gastrointestinal Dysfunction

Keywords

PreforPro; Probiotics; Bacillus subtilis; Prebiotics; Gut health; Gut microbiota; Synergistic effects

Outcome Measures

Primary Outcomes (3)

• Gastrointestinal Health Questionnaire

  Self-assessment of functional measures of gastrointestinal health, including colon and small intestinal pain, gastric function, and gastrointestinal inflammation.

  Evaluated at Baseline and Final (52 days apart) with questions designed to capture function from the prior 4 weeks.

• Bowel Movement Diary

  Daily recording of the number and type (based on Bristol Stool chart) of bowel movements.

  52 days

• Quality of Life Assessment

  Questionnaire that evaluates the impact of gastrointestinal health on daily activities as well as social and psychological impacts.

  Evaluated at Baseline and Final (52 days apart)

Secondary Outcomes (7)

• Gut microbiota changes (beta-diversity)

  2 samples per person, collected ~7 weeks apart

• Gut microbiota changes (alpha diversity)

  2 samples per person, collected ~7 weeks apart

• Intestinal inflammation

  2 samples per person, collected ~7 weeks apart

• Intestinal inflammation

  2 samples per person, collected ~7 weeks apart

• Systemic inflammation

  2 blood samples per person, collected ~7 weeks apart

Other Outcomes (1)

• Body Weight

  Evaluated at baseline and final visits (~52 days)

Study Arms (3)

PreforPro+B. subtilis DE111 probiotics

EXPERIMENTAL

PreforPro is a prebiotic which is a bacteriophage-based product. This prebiotic was used in combination with Bacillus subtilis probiotics.

Dietary Supplement: PreforPro+B. subtilis DE111 probiotics

Placebo(maltodextrin)

PLACEBO COMPARATOR

Maltodextrin was used as a placebo.

Dietary Supplement: Placebo

B. subtilis DE111 alone

ACTIVE COMPARATOR

Bacillus subtilis probiotics was used in this arm alone to compare with the experimental arm.

Dietary Supplement: B. subtilis DE111

Interventions

PreforPro+B. subtilis DE111 probiotics DIETARY_SUPPLEMENT

PreforPro is bacteriophage-based product which was used in combination with Bacillus subtilis probiotics.

PreforPro+B. subtilis DE111 probiotics

Placebo DIETARY_SUPPLEMENT

Maltodextrin is rice based powder which was used as placebo.

Placebo(maltodextrin)

B. subtilis DE111 DIETARY_SUPPLEMENT

Bacillus subtilis probiotics.

B. subtilis DE111 alone

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Equal numbers of healthy male and female volunteers between 18-75 years old with BMI scores of 18.5 to 34.9.

You may not qualify if:

• Individuals less than 18years of age or greater than 75years of age.
• If an individual's BMI is outside of 18.5-34.9.
• History of taking antibiotics and/or probiotics/prebiotics supplementation within 2months of starting antibiotics.
• If individual is on any medications and dietary supplements that would influence the endpoints of the study, such as statins, metformin, NSAIDs and MAO inhibitors.
• If individuals with diagnosis with cancer, liver or kidney disease, gastrointestinal diseases and metabolic disorders.
• Pregnant and breastfeeding women.
• If individual is unable to adhere to study protocol such as consuming capsules for a total 45days, providing stool or blood samples and attending scheduled clinic visits.

Sponsors & Collaborators

• Colorado State University: lead
• Archer Daniels Midland Company: collaborator

Study Sites (1)

Food and Nutrition Clinical Research Lab(FNCRL), Colorado State University

Fort Collins, Colorado, 80526, United States

Location

Related Publications (5)

• Freedman KE, Hill JL, Wei Y, Vazquez AR, Grubb DS, Trotter RE, Wrigley SD, Johnson SA, Foster MT, Weir TL. Examining the Gastrointestinal and Immunomodulatory Effects of the Novel Probiotic Bacillus subtilis DE111. Int J Mol Sci. 2021 Feb 28;22(5):2453. doi: 10.3390/ijms22052453.

  PMID: 33671071 BACKGROUND

• Grubb DS, Wrigley SD, Freedman KE, Wei Y, Vazquez AR, Trotter RE, Wallace TC, Johnson SA, Weir TL. PHAGE-2 Study: Supplemental Bacteriophages Extend Bifidobacterium animalis subsp. lactis BL04 Benefits on Gut Health and Microbiota in Healthy Adults. Nutrients. 2020 Aug 17;12(8):2474. doi: 10.3390/nu12082474.

  PMID: 32824480 BACKGROUND

• Trotter RE, Vazquez AR, Grubb DS, Freedman KE, Grabos LE, Jones S, Gentile CL, Melby CL, Johnson SA, Weir TL. Bacillus subtilis DE111 intake may improve blood lipids and endothelial function in healthy adults. Benef Microbes. 2020 Nov 15;11(7):621-630. doi: 10.3920/BM2020.0039. Epub 2020 Nov 9.

  PMID: 33161737 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

Related Links

• Commercial website for phage product used in the study

Study Officials

• Tiffany L Weir, MSc,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: Participants, study personnel, and outcomes assessor are all blinded to treatment group. Blinding was completed by an independent individual that was not associated with the study or the sponsors.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Nutrition and Food Science

Study Record Dates

• First Submitted: February 20, 2023
• First Posted: March 1, 2023
• Study Start: October 1, 2021
• Primary Completion: December 23, 2022
• Study Completion: March 31, 2024
• Last Updated: June 27, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)