Microbial ColonizationNCT04774042
Probiotic Supplementation in the Dysbiosis of Bowel Preparation
A study testing Infloran probiotic and HAC probiotic in people with Microbial Colonization and Irritable Bowel Syndrome, run by National Taiwan University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Microbial Colonization, Irritable Bowel Syndrome, Metabolic Syndrome
- What is being tested?
- Infloran probiotic and HAC probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Mar 2021to Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults age >20
- Undergoing colonofibroscopy (CFS) with PEG bowel preparation
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Being tested
- Infloran probiotic, HAC probiotic, Infloran placebo, HAC placebo
- Medical subject headings
- Communicable Diseases, Irritable Bowel Syndrome, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infloran probioticDietary supplement
Infloran
HAC probioticDietary supplement
HAc probiotic
Infloran placeboDietary supplement
Infloran placebo
HAC placeboDietary supplement
HAC placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo HAC two packs once daily; Placebo Infloran one pill three times per day for 8 weeks Receives: Dietary Supplement: Infloran placebo; Dietary Supplement: HAC placebo |
| HAC | Experimental | Probiotic HAC two packs once daily; Placebo Infloran one pill three times per day for 8 weeks Receives: Dietary Supplement: HAC probiotic; Dietary Supplement: Infloran placebo |
| Infloran | Experimental | Placebo HAC two packs once daily; Probiotic Infloran one pill three times per day for 8 weeks Receives: Dietary Supplement: Infloran probiotic; Dietary Supplement: HAC placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alpha diversity
Change in alpha diversity of bacterial species post-bowel preparation between probiotic group and placebo group.
Measured: 32 weeks
Beta diversity
Change in beta diversity of bacterial species post-bowel preparation between probiotic group and placebo group.
Measured: 32 weeks
Bacterial species abundance
Change in abundance of bacterial species post-bowel preparation between probiotic group and placebo group.
Measured: 32 weeks
Secondary outcomes (12)
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).
Measured: 32 weeks
BMI
Change in BMI pre- and post-bowel preparation after probiotic or placebo supplementation
Measured: 32 weeks
Insulin resistance
Change in HOMA-IR pre- and post-bowel preparation after probiotic or placebo supplementation
Measured: 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
Measured: 32 weeks
Total cholesterol
Change in Total cholesterol (mg/dL) pre- and post-bowel preparation after probiotic or placebo supplementation
Measured: 32 weeks
LDL
Change in Low density lipoprotein, LDL (mg/dL) pre- and post-bowel preparation after probiotic or placebo supplementation
Measured: 32 weeks
HDL
Change in high density lipoprotein, HDL (mg/dL) pre- and post-bowel preparation after probiotic or placebo supplementation
Measured: 32 weeks
TG
Change in triglyceride, TG (mg/dL) pre- and post-bowel preparation after probiotic or placebo supplementation
Measured: 32 weeks
Weight
Change in weight (Kg) pre- and post-bowel preparation after probiotic or placebo supplementation
Measured: 32 weeks
Waist
Change in Waist (cm) pre- and post-bowel preparation after probiotic or placebo supplementation
Measured: 32 weeks
Fatty liver (grade)
Change in fatty liver severity (grade) pre- and post-bowel preparation after probiotic or placebo supplementation
Measured: 32 weeks
Fatty liver (CAP)
Change in fatty liver severity (CAP, dB/m) pre- and post-bowel preparation after probiotic or placebo supplementation
Measured: 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study startMar 2021 (estimated)
- Primary completionJan 2023 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microbial ColonizationStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Li-Chun Chang, M.D. Ph.D., Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04774042
- Sponsor's protocol ID
- 202006016MIPB
- Status last verified
- Feb 2021
- First submitted
- 19 Feb 2021
- Last updated
- 26 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotic Supplementation in the Dysbiosis of Bowel Preparation
- ClinicalTrials.gov ID
- NCT04774042
- Acronym / sponsor ID
- 202006016MIPB
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Mar 2021 (estimated)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 26 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Infloran placebo, Dietary Supplement: HAC placeboPlacebo HAC two packs once daily; Placebo Infloran one pill three times per day for 8 weeks |
| HAC | Experimental | Dietary Supplement: HAC probiotic, Dietary Supplement: Infloran placeboProbiotic HAC two packs once daily; Placebo Infloran one pill three times per day for 8 weeks |
| Infloran | Experimental | Dietary Supplement: Infloran probiotic, Dietary Supplement: HAC placeboPlacebo HAC two packs once daily; Probiotic Infloran one pill three times per day for 8 weeks |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults age >20
- Undergoing colonofibroscopy (CFS) with PEG bowel preparation
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infloran probioticInfloran | Dietary supplement | Infloran |
| HAC probioticHAc probiotic | Dietary supplement | HAC |
| Infloran placeboInfloran placebo | Dietary supplement | HAC, Placebo |
| HAC placeboHAC placebo | Dietary supplement | Infloran, Placebo |
Primary outcome
Alpha diversity
Time frame: 32 weeks
Change in alpha diversity of bacterial species post-bowel preparation between probiotic group and placebo group.
Beta diversity
Time frame: 32 weeks
Change in beta diversity of bacterial species post-bowel preparation between probiotic group and placebo group.
Bacterial species abundance
Time frame: 32 weeks
Change in abundance of bacterial species post-bowel preparation between probiotic group and placebo group.
12 secondary outcomes
Incidence of functional bowel symptoms
Time frame: 32 weeks
BMI
Time frame: 32 weeks
Insulin resistance
Time frame: 32 weeks
Dyslipidemia
Time frame: 32 weeks
Total cholesterol
Time frame: 32 weeks
LDL
Time frame: 32 weeks
HDL
Time frame: 32 weeks
TG
Time frame: 32 weeks
Weight
Time frame: 32 weeks
Waist
Time frame: 32 weeks
Fatty liver (grade)
Time frame: 32 weeks
Fatty liver (CAP)
Time frame: 32 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li-Chun Chang, M.D. Ph.D. principal investigator
National Taiwan University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Infloran probiotic and HAC probiotic in people with Microbial Colonization and Irritable Bowel Syndrome, run by National Taiwan University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tzu-Chan Hong, M.D. (886-2-972653917, edisonhong77@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alpha diversity (time frame: 32 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2021.