Probiotic Supplementation in the Dysbiosis of Bowel Preparation

• Sponsor: National Taiwan University Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04774042
• Collaborator: (none)
• Enrollment: 300
• Arms: 3
• Anticipated Duration (Months): 22

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Microbial Colonization; Irritable Bowel Syndrome; Metabolic Syndrome	Dietary Supplement: Infloran probiotic; Dietary Supplement: HAC probiotic; Dietary Supplement: Infloran placebo; Dietary Supplement: HAC placebo	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Probiotic Supplementation in the Dysbiosis of Bowel Preparation
• Anticipated Study Start Date: Mar 1, 2021
• Anticipated Primary Completion Date: Jan 1, 2023
• Anticipated Study Completion Date: Jan 1, 2023

Arms and Interventions

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: HAC probiotic; HAc probiotic; Dietary Supplement: Infloran placebo; Infloran placebo
Experimental: Infloran Placebo HAC two packs once daily; Probiotic Infloran one pill three times per day for 8 weeks	Dietary Supplement: Infloran probiotic; Infloran; Dietary Supplement: HAC placebo; HAC placebo

Outcome Measures

Primary Outcome Measures

1. Alpha diversity [32 weeks]

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

2. Beta diversity [32 weeks]

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

3. Bacterial species abundance [32 weeks]

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

Secondary Outcome Measures

1. Incidence of functional bowel symptoms [32 weeks]

   Incidence of GI associated symptoms in 8 weeks (abdominal discomfort, diarrhea, constipation, bloating) after bowel preparation between probiotic group (L) and placebo group (P).

2. BMI [32 weeks]

   Change in BMI pre- and post-bowel preparation after probiotic or placebo supplementation

3. Insulin resistance [32 weeks]

   Change in HOMA-IR pre- and post-bowel preparation after probiotic or placebo supplementation

4. Dyslipidemia [32 weeks]

   Change in lipid profiles (T-CHO, LDL, HDL, TG in mg/dL) pre- and post-bowel preparation after probiotic or placebo supplementation

5. Total cholesterol [32 weeks]

   Change in Total cholesterol (mg/dL) pre- and post-bowel preparation after probiotic or placebo supplementation

6. LDL [32 weeks]

   Change in Low density lipoprotein, LDL (mg/dL) pre- and post-bowel preparation after probiotic or placebo supplementation

7. HDL [32 weeks]

   Change in high density lipoprotein, HDL (mg/dL) pre- and post-bowel preparation after probiotic or placebo supplementation

8. TG [32 weeks]

   Change in triglyceride, TG (mg/dL) pre- and post-bowel preparation after probiotic or placebo supplementation

9. Weight [32 weeks]

   Change in weight (Kg) pre- and post-bowel preparation after probiotic or placebo supplementation

10. Waist [32 weeks]

    Change in Waist (cm) pre- and post-bowel preparation after probiotic or placebo supplementation

11. Fatty liver (grade) [32 weeks]

    Change in fatty liver severity (grade) pre- and post-bowel preparation after probiotic or placebo supplementation

12. Fatty liver (CAP) [32 weeks]

    Change in fatty liver severity (CAP, dB/m) pre- and post-bowel preparation after probiotic or placebo supplementation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• National Taiwan University Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: National Taiwan University Hospital
• ClinicalTrials.gov Identifier: NCT04774042
• Other Study ID Numbers: 202006016MIPB
• First Posted: Feb 26, 2021
• Last Update Posted: Feb 26, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Communicable Diseases; Infections; Irritable Bowel Syndrome; Metabolic Syndrome; Syndrome; Dysbiosis

Study Results

No Results Posted as of Feb 26, 2021