ProbioticsEarly Phase 1NCT01934959
A Trial on Probiotics in Preventing Hirschsprung's Disease Associated Entercolitis
A Early Phase 1 study testing Bifico in people with Probiotics and Hirschsprung's Disease Associated Enterocolitis, run by Tongji Hospital.
Trial summary
Enterocolitis(EC) is the most common and serious postoperative complication of Hirschsprung's disease(HD) with high morbidity and mortality. Probiotics are live microbes that, when administered in adequate amounts, confer health benefit to the host.Based on this previous knowledge on the beneficial effects of… Read more about this study
- Who is it for?
- Ages 1 month to 13 years
- Conditions the study is for
- Probiotics, Hirschsprung's Disease Associated Enterocolitis
- What is being tested?
- Bifico
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2008to Jan 2010
- Phase
- Early 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 1 month to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The inclusion criteria consists of all patients suffering from HD at an age of less than 13 years old, and HD is confirmed by postoperative pathological examination, barium enema and anorectal manometry.
Who cannot join
- Age> 13 years old
- Patients are complicated with mental, neurological disorders (such as hypoxic-ischemic encephalopathy, epilepsy and dementia) or can not thrive.
- Patients are complicated with congenital gastrointestinal malformations (such as anal stenosis, intestinal atresia stenosis), metabolic and endocrine diseases caused by organic constipation and functional constipation in children.
- Children are complicated with liver, kidney dysfunction, blood disorders, immune deficiency diseases and significant ECG abnormalities.
- Children have taken oral antibiotics, microecological modulator, yogurt, other gastrointestinal motility drugs which can affect the gut flora.
- Drug allergies, or allergic diseases..
- Poor compliance with oral probiotics treatment.
About this study
Official title: A Prospective Multicenter Randomized Controlled Trial on Probiotics in Preventing Hirschsprung's Disease Associated Entercolitis
Enterocolitis(EC) is the most common and serious postoperative complication of Hirschsprung's disease(HD) with high morbidity and mortality. Probiotics are live microbes that, when administered in adequate amounts, confer health benefit to the host.Based on this previous knowledge on the beneficial effects of probiotics during pro-inflammatory conditions of the gastrointestinal tract, investigators hypothesized that oral probiotics could decrease the incidence and severity of Hirschsprung's disease associated enterocolitis(HAEC).Investigators conducted a prospective, multicenter, randomized and controlled trial to assess whether oral probiotics could decrease the incidence and severity of Hirschsprung's disease associated enterocolitis(HAEC).
- Being tested
- Bifico
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BificoDrug
| Study group | Role | What they receive |
|---|---|---|
| Probiotics | Experimental | Not described Receives: Drug: Bifico |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probiotics Prevent Hirschsprung's Disease Associated Entercolitis
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2013 (estimated)
- Study startJan 2008
- Primary completionJan 2010
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 ProbioticsStudies of the same condition, open and under way.
- More trials run by Tongji 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Anhui Provincial Hospital
- Responsible party
- Principal investigator, Jiexiong Feng, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01934959
- Sponsor's protocol ID
- Tongji
- Status last verified
- Aug 2013
- First submitted
- 21 Aug 2013
- Last updated
- 4 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wang X, Li Z, Xu Z, Wang Z, Feng J. Probiotics prevent Hirschsprung's disease-associated enterocolitis: a prospective multicenter randomized controlled trial. Int J Colorectal Dis. 2015 Jan;30(1):105-10. doi: 10.1007/s00384-014-2054-0. Epub 2014 Nov 5.
PubMed 25370155
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Randomized Controlled Trial on Probiotics in Preventing Hirschsprung's Disease Associated Entercolitis
- ClinicalTrials.gov ID
- NCT01934959
- Acronym / sponsor ID
- Tongji
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Collaborators
- Anhui Provincial Hospital
- Study start
- Jan 2008
- Primary completion
- Jan 2010 (actual)
- First posted
- 4 Sep 2013 (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.
Enterocolitis(EC) is the most common and serious postoperative complication of Hirschsprung's disease(HD) with high morbidity and mortality. Probiotics are live microbes that, when administered in adequate amounts, confer health benefit to the host.Based on this previous knowledge on the beneficial effects of probiotics during pro-inflammatory conditions of the gastrointestinal tract, investigators hypothesized that oral probiotics could decrease the incidence and severity of Hirschsprung's disease associated enterocolitis(HAEC).Investigators conducted a prospective, multicenter, randomized and controlled trial to assess whether oral probiotics could decrease the incidence and severity of Hirschsprung's disease associated enterocolitis(HAEC).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Probiotics | Experimental | Drug: Bifico |
Who may qualify
- Ages
- 1 month to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- The inclusion criteria consists of all patients suffering from HD at an age of less than 13 years old, and HD is confirmed by postoperative pathological examination, barium enema and anorectal manometry.
Key exclusion criteria (7 listed)
- Age> 13 years old
- Patients are complicated with mental, neurological disorders (such as hypoxic-ischemic encephalopathy, epilepsy and dementia) or can not thrive.
- Patients are complicated with congenital gastrointestinal malformations (such as anal stenosis, intestinal atresia stenosis), metabolic and endocrine diseases caused by organic constipation and functional constipation in children.
- Children are complicated with liver, kidney dysfunction, blood disorders, immune deficiency diseases and significant ECG abnormalities.
- Children have taken oral antibiotics, microecological modulator, yogurt, other gastrointestinal motility drugs which can affect the gut flora.
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 |
|---|---|---|
| Bifico | Drug | Probiotics |
Primary outcome
Probiotics Prevent Hirschsprung's Disease Associated Entercolitis
Time frame: two years
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 4 Sep 2013.
- Derived from this study: PubMed 25370155Wang X, Li Z, Xu Z, Wang Z, Feng J. Probiotics prevent Hirschsprung's disease-associated enterocolitis: a prospective multicenter randomized controlled trial. Int J Colorectal Dis. 2015 Jan;30(1):105-10. doi: 10.1007/s00384-014-2054-0. Epub 2014 Nov 5.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Bifico in people with Probiotics and Hirschsprung's Disease Associated Enterocolitis, run by Tongji 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 1 inclusion and 7 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 4 Sep 2013. 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Probiotics Prevent Hirschsprung's Disease Associated Entercolitis (time frame: two years). 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 NCT01934959, 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 4 Sep 2013.