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Probiotic Supplementation in the Dysbiosis of Bowel Preparation

NCT ID: NCT04774042

Last Updated: 2021-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-31

Study Completion Date

2023-01-31

Brief Summary

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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.

Detailed Description

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Objectives: Colonoscopy is widely used for identification and treatment of colon polyps and intestinal symptoms. High-volume polyethylene glycol (PEG) bowel preparation prior to colonoscopy causes significant dysbiosis of gut microbiota. Currently dysbiosis of gut microbiota is associated with metabolic syndrome and obesity. However, inconclusive conclusions were drawn from clinical trials studying supplementary probiotics and beneficial clinical effects on metabolic parameters. However, no study has addressed the effects of probiotic supplementation on the labile and dynamic intestinal environment following bowel preparation. Aims: Our study aims at studying the short-term and long-term changes on gut microbiota following the probiotic supplementation after bowel preparation. We also aim at studying the changes in abdominal symptoms and parameters of metabolic syndrome. Methods: This study is a prospective, multicentered, randomized double blind three-armed placebo-controlled trial. Targeted population will be those undergoing PEG bowel preparation before colonoscopy. Each individual will be randomly assigned to one of the active probiotic or placebo supplementation. General health parameters and anthropometric measurements, stool, serum lab data, abdominal sonography, oral carnitine/choline challenge tests will be analyzed. The follow-up timepoints are pre- and post-bowel preparation, receiving probiotics/placebo for 8 weeks, 3 months and 6 months thereafter.Outcome measurement: Primary end point: Evaluate the chronological change of gut microbiota post-bowel preparation between probiotic group and placebo group. Secondary end points:To compare incidence of GI associated symptoms after taking probiotics between two groups. Also evaluate the effects of probiotic supplementation on parameters of metabolic syndrome, evaluate the effects on fatty liver and the interaction between SNP variation and the benefit of probiotic supplementation.

Conditions

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Microbial Colonization Irritable Bowel Syndrome Metabolic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

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

Group Type PLACEBO_COMPARATOR

Infloran placebo

Intervention Type DIETARY_SUPPLEMENT

Infloran placebo

HAC placebo

Intervention Type DIETARY_SUPPLEMENT

HAC placebo

HAC

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

Group Type EXPERIMENTAL

HAC probiotic

Intervention Type DIETARY_SUPPLEMENT

HAc probiotic

Infloran placebo

Intervention Type DIETARY_SUPPLEMENT

Infloran placebo

Infloran

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

Group Type EXPERIMENTAL

Infloran probiotic

Intervention Type DIETARY_SUPPLEMENT

Infloran

HAC placebo

Intervention Type DIETARY_SUPPLEMENT

HAC placebo

Interventions

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Infloran probiotic

Infloran

Intervention Type DIETARY_SUPPLEMENT

HAC probiotic

HAc probiotic

Intervention Type DIETARY_SUPPLEMENT

Infloran placebo

Infloran placebo

Intervention Type DIETARY_SUPPLEMENT

HAC placebo

HAC placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

1. Adults age \>20
2. Undergoing colonofibroscopy (CFS) with PEG bowel preparation

Exclusion Criteria

1. Inadequate bowel preparation
2. Subjects with active cancer or IBD (inflammatory bowel disease)
3. Subjects with history of abdominal surgery (including stomach, gallbladder, pancreas, small bowel, large bowel)
4. Subjects who take medication related to gastrointestinal motility within 1 months
5. Subjects who take antibiotics or probiotics within 1 months
6. Subjects under pregnancy
7. Allergic or intolerance to the study medication
8. Refused to randomization
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Li-Chun Chang, M.D. Ph.D.

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Central Contacts

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Tzu-Chan Hong, M.D.

Role: CONTACT

Phone: 886-2-972653917

Email: [email protected]

Other Identifiers

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202006016MIPB

Identifier Type: -

Identifier Source: org_study_id