Probiotic Supplementation in the Dysbiosis of Bowel Preparation

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Irritable Bowel Syndrome; Metabolic Syndrome; Microbial Colonization
• Intervention / Treatment: Dietary supplement: Infloran placebo; Dietary supplement: HAC placebo; Dietary supplement: HAC probiotic; Dietary supplement: Infloran probiotic

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tzu-Chan Hong, M.D.; Phone Number: 886-2-972653917; Email: edisonhong77@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo HAC two packs once daily; Placebo Infloran one pill three times per day for 8 weeks	Dietary supplement: Infloran placebo; Infloran placebo; Dietary supplement: HAC placebo; HAC placebo
Experimental: HAC; Probiotic HAC two packs once daily; Placebo Infloran one pill three times per day for 8 weeks	Dietary supplement: Infloran placebo; Infloran placebo; Dietary supplement: HAC probiotic; HAc probiotic
Experimental: Infloran; Placebo HAC two packs once daily; Probiotic Infloran one pill three times per day for 8 weeks	Dietary supplement: HAC placebo; HAC placebo; Dietary supplement: Infloran probiotic; Infloran

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of functional bowel symptoms	Incidence of GI associated symptoms in 8 weeks (abdominal discomfort, diarrhea, constipation, bloating) after bowel preparation between probiotic group (L) and placebo group (P).	32 weeks
BMI	Change in BMI pre- and post-bowel preparation after probiotic or placebo supplementation	32 weeks
Insulin resistance	Change in HOMA-IR pre- and post-bowel preparation after probiotic or placebo supplementation	32 weeks
Dyslipidemia	Change in lipid profiles (T-CHO, LDL, HDL, TG in mg/dL) pre- and post-bowel preparation after probiotic or placebo supplementation	32 weeks
Total cholesterol	Change in Total cholesterol (mg/dL) pre- and post-bowel preparation after probiotic or placebo supplementation	32 weeks
LDL	Change in Low density lipoprotein, LDL (mg/dL) pre- and post-bowel preparation after probiotic or placebo supplementation	32 weeks
HDL	Change in high density lipoprotein, HDL (mg/dL) pre- and post-bowel preparation after probiotic or placebo supplementation	32 weeks
TG	Change in triglyceride, TG (mg/dL) pre- and post-bowel preparation after probiotic or placebo supplementation	32 weeks
Weight	Change in weight (Kg) pre- and post-bowel preparation after probiotic or placebo supplementation	32 weeks
Waist	Change in Waist (cm) pre- and post-bowel preparation after probiotic or placebo supplementation	32 weeks
Fatty liver (grade)	Change in fatty liver severity (grade) pre- and post-bowel preparation after probiotic or placebo supplementation	32 weeks
Fatty liver (CAP)	Change in fatty liver severity (CAP, dB/m) pre- and post-bowel preparation after probiotic or placebo supplementation	32 weeks

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Li-Chun Chang, M.D. Ph.D., National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2021
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): January 1, 2023

Study Registration Dates

• First Submitted: February 19, 2021
• First Submitted That Met QC Criteria: February 25, 2021
• First Posted (Actual): February 26, 2021

Study Record Updates

• Last Update Posted (Actual): February 26, 2021
• Last Update Submitted That Met QC Criteria: February 25, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease Attributes; Disease; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Insulin Resistance; Hyperinsulinism; Syndrome; Irritable Bowel Syndrome; Infections; Communicable Diseases; Metabolic Syndrome; Dysbiosis
• Other Study ID Numbers: 202006016MIPB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No