NCT04774042

Brief Summary

Significant changes in gut microbiota was noted after the high-volume bowel preparation with PEG before colonoscopy. The dynamic changes were found to be short-term. However, the perturbation pattern of gut microbiota found after bowel preparation may link to metabolic syndrome and obesity. No study had investigated the supplementation of probiotic in this dynamic situation before. Here we proposed this study to fulfill the knowledge gap and also inquiry on the potential therapeutic strategy.1.To test the hypothesis of probiotic supplementation after bowel preparation alters the composition of gut microbiota in a short-term and long-term manner.2.To test the hypothesis of GI tract associated symptoms affected by probiotic supplementation after bowel preparation. 3. To test the hypothesis of clinical events, especially parameters of metabolic syndrome affected by probiotic supplementation after bowel preparation.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2021

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 26, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

February 26, 2021

Status Verified

February 1, 2021

Enrollment Period

1.8 years

First QC Date

February 19, 2021

Last Update Submit

February 25, 2021

Conditions

Microbial ColonizationIrritable Bowel SyndromeMetabolic Syndrome

Outcome Measures

Primary Outcomes (3)

  • Alpha diversity

    Change in alpha diversity of bacterial species post-bowel preparation between probiotic group and placebo group.

    32 weeks

  • Beta diversity

    Change in beta diversity of bacterial species post-bowel preparation between probiotic group and placebo group.

    32 weeks

  • Bacterial species abundance

    Change in abundance of bacterial species post-bowel preparation between probiotic group and placebo group.

    32 weeks

Secondary Outcomes (12)

  • Incidence of functional bowel symptoms

    32 weeks

  • BMI

    32 weeks

  • Insulin resistance

    32 weeks

  • Dyslipidemia

    32 weeks

  • Total cholesterol

    32 weeks

  • +7 more secondary outcomes

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo HAC two packs once daily; Placebo Infloran one pill three times per day for 8 weeks

Dietary Supplement: Infloran placeboDietary Supplement: HAC placebo

HAC

EXPERIMENTAL

Probiotic HAC two packs once daily; Placebo Infloran one pill three times per day for 8 weeks

Dietary Supplement: HAC probioticDietary Supplement: Infloran placebo

Infloran

EXPERIMENTAL

Placebo HAC two packs once daily; Probiotic Infloran one pill three times per day for 8 weeks

Dietary Supplement: Infloran probioticDietary Supplement: HAC placebo

Interventions

Infloran probioticDIETARY_SUPPLEMENT

Infloran

Infloran
HAC probioticDIETARY_SUPPLEMENT

HAc probiotic

HAC
Infloran placeboDIETARY_SUPPLEMENT

Infloran placebo

HACPlacebo
HAC placeboDIETARY_SUPPLEMENT

HAC placebo

InfloranPlacebo

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults age \>20
  • Undergoing colonofibroscopy (CFS) with PEG bowel preparation

You may not qualify if:

  • Inadequate bowel preparation
  • Subjects with active cancer or IBD (inflammatory bowel disease)
  • Subjects with history of abdominal surgery (including stomach, gallbladder, pancreas, small bowel, large bowel)
  • Subjects who take medication related to gastrointestinal motility within 1 months
  • Subjects who take antibiotics or probiotics within 1 months
  • Subjects under pregnancy
  • Allergic or intolerance to the study medication
  • Refused to randomization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Communicable DiseasesIrritable Bowel SyndromeMetabolic Syndrome

Condition Hierarchy (Ancestors)

InfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsColonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Li-Chun Chang, M.D. Ph.D.

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tzu-Chan Hong, M.D.

CONTACT

886-2-972653917edisonhong77@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2021

First Posted

February 26, 2021

Study Start

March 1, 2021

Primary Completion

January 1, 2023

Study Completion

January 1, 2023

Last Updated

February 26, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share