Slow Transit ConstipationPhase 2NCT02844426
Effect of a Synbiotic on Symptoms of Patients With STC
A Phase 2 study testing bifid triple viable capsule and pectin and maltodextrin in people with Slow Transit Constipation, run by Jinling Hospital, China at 1 site in China.
Trial summary
To evaluate the efficacy of synbiotic (BIFICOPEC) containing Enterococci, Bifidobacteria, Lactobacilli triple viable bacteria and pectin in patients with slow transit constipation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Slow Transit Constipation
- What is being tested?
- bifid triple viable capsule and pectin and maltodextrin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Sep 2015to Sep 2016
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥ 18 years;
- BMI: 18.5-25kg/m2;
- chronic constipation was diagnosed according to RomeⅢ criteria;
- colonic transit time (CTT) >48 hours;
- mild-to-moderate constipation with wexner constipation scale between 16 and 25.
Who cannot join
- megacolon, intestinal obstruction, inflammatory bowel disease, and cancer;
- secondary constipation (i.e. drugs, endocrine disorders, neurological disorders, metabolic disorders, psychological disorders or abdominal surgery);
- severe anterior rectocele or full thickness rectorectal intussusception according to defecography;
- pregnant or lactating women;
- infection with enteric pathogen;
- usage of antibiotics or proton pump inhibitors (PPIs);
- hepatic, renal, cardiovascular, respiratory or psychiatric disease;
- other diseases or factors evaluated by the investigator which could influence intestinal transit or intestinal microbiota.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
Nanjing, Jiangsu, 210002
About this study
Official title: Effect of a Synbiotic on Symptoms of Patients With Slow Transit Constipation: A Prospective Randomized Trial
To evaluate the efficacy of synbiotic (BIFICOPEC) containing Enterococci, Bifidobacteria, Lactobacilli triple viable bacteria and pectin in patients with slow transit constipation.
Read the detailed description
Chronic constipation has become a common, often chronic, functional gastrointestinal disease which influences the quality of life all over the world. A total of 100 patients diagnosed as slow transit constipation (STC) using Rome III criteria were randomized to receive either synbiotic or placebo twice daily for 12 weeks. The primary efficacy endpoint was the clinical remission and improvement rate at week 4 and 12. Stool frequency and consistency, colonic transit time (CTT), evacuation and abdominal symptoms, Patient Assessment of Constipation Symptoms (PAC-SYM scores), Gastrointestinal Quality-of-Life Index (GIQLI), Satisfaction scores and adverse events were also monitored.
- Conditions
- Slow Transit Constipation
- Being tested
- bifid triple viable capsule and pectin, maltodextrin
- Keywords
- synbiotic, soluble dietary fiber, slow transit constipation, microbiota
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bifid triple viable capsule and pectinDrug
maltodextrinDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | patients allowed to take maltodextrin by the experienced doctor. Receives: Drug: maltodextrin |
| synbiotic | Experimental | patients are allowed to take synbiotic (BIFICOPEC) contained 0.63g bifid triple viable capsule (BIFICO) and 8g soluble dietary fiber (Pectin) . Receives: Drug: bifid triple viable capsule and pectin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical remission rate
Patients having an average of three or more spontaneous complete bowel movements (SCBMs) per week were defined as remission.
Measured: 3 months
Clinical improvement rate
Patients with an average increase of one or more spontaneous complete bowel movements (SCBMs) per week were defined as improvement.
Measured: 3 months
Secondary outcomes (9)
Number of bowel movements per week
Measured: 3 months
Stool consistency according to the Bristol Stool Form Scale (BSFS)
Stool types 1 and 2 indicated constipation; types 3, 4, and 5 indicated normal; and types 6 and 7 indicated diarrhea.
Measured: 3 months
Colonic transit time (CTT)
CTT was measured by Metcalf method.
Measured: 3 months
Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire
The questionnaire contained 12 symptoms which were grouped into three subscales for stool, abdominal and rectal symptoms.
Measured: 3 months
The Gastrointestinal Quality-of-Life Index (GIQLI)
To evaluate specific quality of life in patients with gastrointestinal diseases, comprised 36 questions using a 5-point Likert-type scale ranging from 0 to 4 (0, worst; 4, best).
Measured: 3 months
Satisfaction score of constipated patients
The score ranged from 1 (extremely unsatisfied) to 5 (extremely satisfied).
Measured: 3 months
Abdominal symptoms
Patients recorded their symptoms of abdominal pain or cramps and bloating or flatulence according to five classifications of symptoms (1, none; 2, mild; 3, moderate; 4, severe; 5, very severe).
Measured: 3 months
Evacuation symptoms
Patients recorded their perception of straining, lumpy hard stools, sensation of incomplete evacuation, and sensation of anorectal blockage according to a 5-point ordinal scale (1, none; 2, mild; 3, moderate; 4, severe; 5, very severe).
Measured: 3 months
Treatment-related adverse events
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2016 (estimated)
- Study startSep 2015
- Primary completionJun 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Slow Transit ConstipationStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jinling Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianfeng Gong, Jinling Hospital, China
- Investigators
- Ning Li, Study director, department of generay surgery, jinling hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02844426
- Sponsor's protocol ID
- BIFICOPEC-2015
- Status last verified
- Sep 2016
- First submitted
- 20 Jul 2016
- Last updated
- 30 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Synbiotic on Symptoms of Patients With Slow Transit Constipation: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT02844426
- Acronym / sponsor ID
- BIFICOPEC-2015
- Conditions
- Slow Transit Constipation
- Keywords
- synbiotic, soluble dietary fiber, slow transit constipation, microbiota
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Jinling Hospital, ChinaUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 26 Jul 2016 (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.
To evaluate the efficacy of synbiotic (BIFICOPEC) containing Enterococci, Bifidobacteria, Lactobacilli triple viable bacteria and pectin in patients with slow transit constipation.
Detailed description
Chronic constipation has become a common, often chronic, functional gastrointestinal disease which influences the quality of life all over the world. A total of 100 patients diagnosed as slow transit constipation (STC) using Rome III criteria were randomized to receive either synbiotic or placebo twice daily for 12 weeks. The primary efficacy endpoint was the clinical remission and improvement rate at week 4 and 12. Stool frequency and consistency, colonic transit time (CTT), evacuation and abdominal symptoms, Patient Assessment of Constipation Symptoms (PAC-SYM scores), Gastrointestinal Quality-of-Life Index (GIQLI), Satisfaction scores and adverse events were also monitored.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: maltodextrinpatients allowed to take maltodextrin by the experienced doctor. |
| synbiotic | Experimental | Drug: bifid triple viable capsule and pectinpatients are allowed to take synbiotic (BIFICOPEC) contained 0.63g bifid triple viable capsule (BIFICO) and 8g soluble dietary fiber (Pectin) . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age ≥ 18 years;
- BMI: 18.5-25kg/m2;
- chronic constipation was diagnosed according to RomeⅢ criteria;
- colonic transit time (CTT) >48 hours;
- mild-to-moderate constipation with wexner constipation scale between 16 and 25.
Key exclusion criteria (8 listed)
- megacolon, intestinal obstruction, inflammatory bowel disease, and cancer;
- secondary constipation (i.e. drugs, endocrine disorders, neurological disorders, metabolic disorders, psychological disorders or abdominal surgery);
- severe anterior rectocele or full thickness rectorectal intussusception according to defecography;
- pregnant or lactating women;
- infection with enteric pathogen;
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 |
|---|---|---|
| bifid triple viable capsule and pectin | Drug | synbiotic |
| maltodextrin | Drug | Placebo |
Primary outcome
Clinical remission rate
Time frame: 3 months
Patients having an average of three or more spontaneous complete bowel movements (SCBMs) per week were defined as remission.
Clinical improvement rate
Time frame: 3 months
Patients with an average increase of one or more spontaneous complete bowel movements (SCBMs) per week were defined as improvement.
9 secondary outcomes
Number of bowel movements per week
Time frame: 3 months
Stool consistency according to the Bristol Stool Form Scale (BSFS)
Time frame: 3 months
Colonic transit time (CTT)
Time frame: 3 months
Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire
Time frame: 3 months
The Gastrointestinal Quality-of-Life Index (GIQLI)
Time frame: 3 months
Satisfaction score of constipated patients
Time frame: 3 months
Abdominal symptoms
Time frame: 3 months
Evacuation symptoms
Time frame: 3 months
Treatment-related adverse events
Time frame: 3 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 30 Sep 2016.
Related trials for Slow Transit Constipation
RecruitingPhase 3
Efficacy and Safety of Lubiprostone in the Treatment of Slow Transit Constipation
Slow Transit Constipation, Pharmacotherapy
Active, not recruiting
STOPS Trial: Total vs Subtotal Colectomy for Slow Transit Constipation
Slow Transit Constipation, Surgery
Not yet recruitingObservational study
Preoperative Fish Oil PN and Prognosis After Constipation Surgery
Constipation, Slow Transit Constipation
Recruiting
MSOT and MRI for Non-invasive Assessment of Intestinal Transit Time in Children With Chronic Bowel Emptying Disorders
Chronic Constipation, Slow Transit Constipation
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.
Ning Li study director
department of generay surgery, jinling hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing bifid triple viable capsule and pectin and maltodextrin in people with Slow Transit Constipation, run by Jinling Hospital, China 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 5 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: finished, as of the sponsor's last update on 30 Sep 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. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Clinical remission rate (time frame: 3 months). The study lists 2 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 30 Sep 2016.