Irritable Bowel SyndromePhase 1NCT02254629
The Effects of Laxative-probiotic Sequential Treatment in the Irritable Bowel Syndrome Patients
A Phase 1 study testing Probiotic Clostridium Butyricum and Laxative Polyethylene Glycol in people with Irritable Bowel Syndrome, run by Shandong University at 1 site in China.
Trial summary
the laxative-probiotic sequential treatment might reduce the symptoms of IBS and alter the fecal microbiota of the patients in a more robust manner . Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Probiotic Clostridium Butyricum and Laxative Polyethylene Glycol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteChina
- Study dates
- Jul 2014to Jul 2016
- Phase
- Phase 1
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- the presence of Rome III criteria for IBS ;
- Patients scheduled for colonoscopy examination or having negative screening examinations
- Aged between 18 and 65 years old
Who cannot join
- Antibiotic, probiotic or laxative usage within 4 weeks.
- organic gastrointestinal diseases
- Severe systematic disease: diabetes mellitus, hepatic, renal or cardiac dysfunction, thyroid disease or tumor etc.
- pregnancy or lactation.
- previous major or complicated abdominal surgery.
- severe endometriosis and dementia
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Gastroenterology, Qilu Hospital, Shandong University
Jinan, Shandong, 250012
About this study
Official title: The Effects of Laxative-probiotic Sequential Treatment on the Symptoms and Fecal Microbiota in the IBS Patients.
the laxative-probiotic sequential treatment might reduce the symptoms of IBS and alter the fecal microbiota of the patients in a more robust manner .
Read the detailed description
Probiotics can regulate intestinal immunity, repair mucosal barrier, and reportedly exert therapeutic effects on IBS patients. The laxatives could also alter the gut microflora significantly, thus the laxative-probiotic sequential treatment might affect the symptoms and the composition of fecal microbiota in the IBS patients in a more robust manner .
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Probiotic Clostridium Butyricum, Laxative Polyethylene Glycol
- Keywords
- Fecal microflora, IBS, Sequential treatment, Probiotic, Laxative
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic Clostridium ButyricumDrug
Also called Clostridium Butyricum Tablets
probiotic:2 tablets/ times, 3 times / day for 2 weeks
Laxative Polyethylene GlycolDrug
Also called Polyethylene Glycol Electrolytes Powder.
laxative：2000 ml.
| Study group | Role | What they receive |
|---|---|---|
| laxative-probiotic sequential | Experimental | laxative：2000 ml. Probiotic：2 tablets/ times, 3 times / day for the first 2 weeks，immediately after colonoscopy Receives: Drug: Probiotic Clostridium Butyricum; Drug: Laxative Polyethylene Glycol |
| probiotic | Active comparator | Probiotic：2 tablets/ times, 3 times / day for the first 2 weeks. Receives: Drug: Probiotic Clostridium Butyricum |
| Laxative followed by Probiotic 2 weeks later | Active comparator | laxative：2000 ml. Probiotic：2 tablets/ times, 3 times / day for the last 2 weeks with two weeks interval after colonoscopy. Receives: Drug: Probiotic Clostridium Butyricum; Drug: Laxative Polyethylene Glycol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject's Global Assessment of Relief
The SGA (subjective global assessment) of Relief was assessed by answering the following question: "Please consider how you felt this past week in regard to your IBS, in particular your overall wellbeing, symptoms and altered bowel habit. Compared to the way you usually felt before entering the study, how would you rate your relief of symptoms during the past week?" The scale contained five possible answers: (1) completely relieved, (2) considerably relieved, (3) somewhat relieved, (4) unchanged, or (5) worse.
Measured: 8 months
Secondary outcomes (3)
The changes of symptom scores
The symptom score includes abdominal pain, discomfort, bloating, stool frequency, stool consistency according to Bristol stool form scale and defecation urgency，imcomplete，straining.
Measured: 8 months
IBS patients'quality of life
Quality of life was determined by using IBS-QOL scoring system for patients with IBS. This questionnaire comprises a range of 34 items with response options on a 5-point rating scale. The items contribute to 8 domains as follows: Dysphoria, Interference with activity, Body image, Health worry, Food avoidance, Social reaction, Sexual, Relationship.
Measured: 8 months
Composition of Microorganisms in stool
Primary coordination of fecal samples' 16s rDNA (ribosomal deoxyribonucleic acid) will be compared between two Groups using Braycurtis distance based Primary coordination analysis (PCoA).
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2014 (estimated)
- Study startJul 2014
- Primary completionAug 2015
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanqing Li, Shandong University
- Investigators
- Yanqing Li, MD.PhD, Principal investigator, Qilu Hospital of Shandong UniversityYanqing Li, MD.PhD., Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02254629
- Sponsor's protocol ID
- 2014SDU-QILU-G04
- Status last verified
- Aug 2016
- First submitted
- 28 Aug 2014
- Last updated
- 31 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Li M, Xu R, Li YQ. Sequential laxative-probiotic usage for treatment of irritable bowel syndrome: a novel method inspired by mathematical modelling of the microbiome. Sci Rep. 2020 Nov 9;10(1):19291. doi: 10.1038/s41598-020-75225-z.
PubMed 33168839
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Laxative-probiotic Sequential Treatment on the Symptoms and Fecal Microbiota in the IBS Patients.
- ClinicalTrials.gov ID
- NCT02254629
- Acronym / sponsor ID
- 2014SDU-QILU-G04
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Fecal microflora, IBS, Sequential treatment, Probiotic, Laxative
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 2 Oct 2014 (estimated)
- 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.
the laxative-probiotic sequential treatment might reduce the symptoms of IBS and alter the fecal microbiota of the patients in a more robust manner .
Detailed description
Probiotics can regulate intestinal immunity, repair mucosal barrier, and reportedly exert therapeutic effects on IBS patients. The laxatives could also alter the gut microflora significantly, thus the laxative-probiotic sequential treatment might affect the symptoms and the composition of fecal microbiota in the IBS patients in a more robust manner .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| laxative-probiotic sequential | Experimental | Drug: Probiotic Clostridium Butyricum, Drug: Laxative Polyethylene Glycollaxative：2000 ml. Probiotic：2 tablets/ times, 3 times / day for the first 2 weeks，immediately after colonoscopy |
| probiotic | Active comparator | Drug: Probiotic Clostridium ButyricumProbiotic：2 tablets/ times, 3 times / day for the first 2 weeks. |
| Laxative followed by Probiotic 2 weeks later | Active comparator | Drug: Probiotic Clostridium Butyricum, Drug: Laxative Polyethylene Glycollaxative：2000 ml. Probiotic：2 tablets/ times, 3 times / day for the last 2 weeks with two weeks interval after colonoscopy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- the presence of Rome III criteria for IBS ;
- Patients scheduled for colonoscopy examination or having negative screening examinations
- Aged between 18 and 65 years old
Key exclusion criteria (6 listed)
- Antibiotic, probiotic or laxative usage within 4 weeks.
- organic gastrointestinal diseases
- Severe systematic disease: diabetes mellitus, hepatic, renal or cardiac dysfunction, thyroid disease or tumor etc.
- pregnancy or lactation.
- previous major or complicated abdominal surgery.
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 |
|---|---|---|
| Probiotic Clostridium ButyricumAlso: Clostridium Butyricum Tabletsprobiotic:2 tablets/ times, 3 times / day for 2 weeks | Drug | Laxative followed by Probiotic 2 weeks later, laxative-probiotic sequential, probiotic |
| Laxative Polyethylene GlycolAlso: Polyethylene Glycol Electrolytes Powder.laxative：2000 ml. | Drug | Laxative followed by Probiotic 2 weeks later, laxative-probiotic sequential |
Primary outcome
Subject's Global Assessment of Relief
Time frame: 8 months
The SGA (subjective global assessment) of Relief was assessed by answering the following question: "Please consider how you felt this past week in regard to your IBS, in particular your overall wellbeing, symptoms and altered bowel habit. Compared to the way you usually felt before entering the study, how would you rate your relief of symptoms during the past week?" The scale contained five possible answers: (1) completely relieved, (2) considerably relieved, (3) somewhat relieved, (4) unchanged, or (5) worse.
3 secondary outcomes
The changes of symptom scores
Time frame: 8 months
IBS patients'quality of life
Time frame: 8 months
Composition of Microorganisms in stool
Time frame: 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2016.
- Derived from this study: PubMed 33168839Li M, Xu R, Li YQ. Sequential laxative-probiotic usage for treatment of irritable bowel syndrome: a novel method inspired by mathematical modelling of the microbiome. Sci Rep. 2020 Nov 9;10(1):19291. doi: 10.1038/s41598-020-75225-z.
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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.
Yanqing Li, MD.PhD principal investigator
Qilu Hospital of Shandong University
Yanqing Li, MD.PhD. principal investigator
Qilu Hospital of Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Probiotic Clostridium Butyricum and Laxative Polyethylene Glycol in people with Irritable Bowel Syndrome, run by Shandong University at 1 site in China.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 31 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subject's Global Assessment of Relief (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02254629, which also lists 1 linked publication.
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 31 Aug 2016.