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

NCT05750433 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-06-27

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

PreforPro+B. subtilis DE111 probiotics

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

DIETARY_SUPPLEMENT

Placebo

Maltodextrin is rice based powder which was used as placebo.

DIETARY_SUPPLEMENT

B. subtilis DE111

Bacillus subtilis probiotics.

Sponsors & Collaborators

  • Archer Daniels Midland Company

    collaborator UNKNOWN

  • Colorado State University

    lead OTHER

Principal Investigators

  • Tiffany L Weir, MSc,PhD · Colorado State University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-01
Primary Completion
2022-12-23
Completion
2024-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05750433 on ClinicalTrials.gov