CombizymPhase 4NCT02097394
The Clinical Study on Combizym and Bifidobacteri to Prevent the Recurrence of Colon Polyps
A Phase 4 study testing Combizym, Bifidobacteri and Combizym + Bifidobacteri in people with Combizym and Bifidobacteri, run by RenJi Hospital at 1 site in China.
Trial summary
The study hypothesis is whether digestion enzyme(Combizym) and intestinal flora drugs(Bifidobacteria) can decease recurrence rate of colon polyps Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Combizym, Bifidobacteri, Colon Polyps
- What is being tested?
- Combizym, Bifidobacteri and Combizym + Bifidobacteri
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Jun 2013to Jun 2020
- Phase
- Phase 4
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Patients who have cutted colon polyps in one month, and the diagnosis were proved by pathological analysis
Who cannot join
- have organic or other functional disease
- pregnant or breast-feeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Study on Combizym and Bifidobacteria to Prevent the Recurrence of Colon Polyps
The study hypothesis is whether digestion enzyme(Combizym) and intestinal flora drugs(Bifidobacteria) can decease recurrence rate of colon polyps
Read the detailed description
Colon polyps has high recurrence rate in the digestion diseases. However, the reasons are not clear. The possible reasons for the recurrence of colon polyps include intestinal inflammation (e.g., Ulcerative colitis), intestinal flora imbalance (the benefit intestinal bacteria reduced, which lead to diarrhea or constipation), long-term indigestion. The investigators propose to examine whether digestion enzyme (Combizym) and intestinal flora drugs(Bifidobacteria) can decease recurrence rate of colon polyps
- Conditions
- Combizym, Bifidobacteri, Colon Polyps
- Being tested
- Combizym, Bifidobacteri, Combizym + Bifidobacteri
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CombizymDrug
Also called Oryz-Aspergillus Enzyme And Pancreatin Tablet, (provided by Nordmark Arzneimittel GmbH & Co. KG)
Combizym( 1 tablet, po, tid)
BifidobacteriDrug
Also called Live Combined Bifidobacterium，Lactobac and Enterococcus Capsules, (produced by Shanghai XinYi Company)
Bifidobacteri (2 tablet, po, tid)
Combizym + BifidobacteriDrug
Also called Combizym(Oryz-Aspergillus Enzyme And Pancreatin Tablet), (produced by Nordmark Arzneimittel GmbH & Co. KG), Bifidobacteri(Live Combined Bifidobacterium，Lactobac and Enterococcus Capsules), (produced by Shanghai XinYi Company)
Combizym( 1 tablet, po, tid) + Bifidobacteri (2 tablet, po, tid)
| Study group | Role | What they receive |
|---|---|---|
| Combizym-treated group | Active comparator | The patients who received polypectomy of colon polyps take the digestion enzyme (Combizym) regularly. Receives: Drug: Combizym |
| Bifidobacteri-treated group | Active comparator | The patients who received polypectomy of colon polyps take Bifidobacteri regularly Receives: Drug: Bifidobacteri |
| Combizym + Bifidobacteri-treated group | Active comparator | The patients who received polypectomy of colon polyps take drugs (Combizym + Bifidobacteri) regularly Receives: Drug: Combizym + Bifidobacteri |
| control | No intervention | The patients who received polypectomy of colon polyps take no drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence of colon polyps
The whole patients need be examined by colonoscopy one year later. The recurrence rate of colon polyps will be acquired in different arms
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2014 (estimated)
- Study startJun 2013
- Primary completionJun 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CombizymStudies of the same condition, open and under way.
- More trials run by RenJi 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shengliang Chen, RenJi Hospital
- Investigators
- Shengliang Chen, Study director, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02097394
- Sponsor's protocol ID
- RJYYXHNK-002
- Status last verified
- Mar 2020
- First submitted
- 12 Jul 2013
- Last updated
- 5 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study on Combizym and Bifidobacteria to Prevent the Recurrence of Colon Polyps
- ClinicalTrials.gov ID
- NCT02097394
- Acronym / sponsor ID
- RJYYXHNK-002
- Conditions
- Combizym, Bifidobacteri, Colon Polyps
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (actual)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- Jun 2013 (actual)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 27 Mar 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 study hypothesis is whether digestion enzyme(Combizym) and intestinal flora drugs(Bifidobacteria) can decease recurrence rate of colon polyps
Detailed description
Colon polyps has high recurrence rate in the digestion diseases. However, the reasons are not clear. The possible reasons for the recurrence of colon polyps include intestinal inflammation (e.g., Ulcerative colitis), intestinal flora imbalance (the benefit intestinal bacteria reduced, which lead to diarrhea or constipation), long-term indigestion. The investigators propose to examine whether digestion enzyme (Combizym) and intestinal flora drugs(Bifidobacteria) can decease recurrence rate of colon polyps
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Combizym-treated group | Active comparator | Drug: CombizymThe patients who received polypectomy of colon polyps take the digestion enzyme (Combizym) regularly. |
| Bifidobacteri-treated group | Active comparator | Drug: BifidobacteriThe patients who received polypectomy of colon polyps take Bifidobacteri regularly |
| Combizym + Bifidobacteri-treated group | Active comparator | Drug: Combizym + BifidobacteriThe patients who received polypectomy of colon polyps take drugs (Combizym + Bifidobacteri) regularly |
| control | No intervention | –The patients who received polypectomy of colon polyps take no drugs |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Patients who have cutted colon polyps in one month, and the diagnosis were proved by pathological analysis
Key exclusion criteria (2 listed)
- have organic or other functional disease
- pregnant or breast-feeding
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 |
|---|---|---|
| CombizymAlso: Oryz-Aspergillus Enzyme And Pancreatin Tablet, (provided by Nordmark Arzneimittel GmbH & Co. KG)Combizym( 1 tablet, po, tid) | Drug | Combizym-treated group |
| BifidobacteriAlso: Live Combined Bifidobacterium，Lactobac and Enterococcus Capsules, (produced by Shanghai XinYi Company)Bifidobacteri (2 tablet, po, tid) | Drug | Bifidobacteri-treated group |
| Combizym + BifidobacteriAlso: Combizym(Oryz-Aspergillus Enzyme And Pancreatin Tablet), (produced by Nordmark Arzneimittel GmbH & Co. KG), Bifidobacteri(Live Combined Bifidobacterium，Lactobac and Enterococcus Capsules), (produced by Shanghai XinYi Company)Combizym( 1 tablet, po, tid) + Bifidobacteri (2 tablet, po, tid) | Drug | Combizym + Bifidobacteri-treated group |
Primary outcome
recurrence of colon polyps
Time frame: one year
The whole patients need be examined by colonoscopy one year later. The recurrence rate of colon polyps will be acquired in different arms
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2020.
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.
Shengliang Chen study director
RenJi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Combizym, Bifidobacteri and Combizym + Bifidobacteri in people with Combizym and Bifidobacteri, run by RenJi Hospital 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 1 inclusion and 2 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 5 Mar 2020. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
recurrence of colon polyps (time frame: one year). 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 5 Mar 2020.