Clinical trial NCT04774042: Probiotic Supplementation in the Dysbiosis of Bowel Preparation
Official title: Probiotic Supplementation in the Dysbiosis of Bowel Preparation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Microbial Colonization
Irritable Bowel Syndrome
Metabolic Syndrome
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2021-02-26
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Alpha diversity
timeFrame: 32 weeks
measure: Beta diversity
timeFrame: 32 weeks
measure: Bacterial species abundance
timeFrame: 32 weeks
Secondary outcomes:
measure: Incidence of functional bowel symptoms
timeFrame: 32 weeks
measure: BMI
timeFrame: 32 weeks
measure: Insulin resistance
timeFrame: 32 weeks
measure: Dyslipidemia
timeFrame: 32 weeks
measure: Total cholesterol
timeFrame: 32 weeks
measure: LDL
timeFrame: 32 weeks
measure: HDL
timeFrame: 32 weeks
measure: TG
timeFrame: 32 weeks
measure: Weight
timeFrame: 32 weeks
measure: Waist
timeFrame: 32 weeks
measure: Fatty liver (grade)
timeFrame: 32 weeks
measure: Fatty liver (CAP)
timeFrame: 32 weeks
Other outcomes:
Locations:
Study officials:
affiliation: National Taiwan University Hospital
name: Li-Chun Chang, M.D. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: