ConstipationNCT02255747
Anal Dilatation for Infants and Children With Constipation
A study testing Lactulose in people with Constipation, run by Tongji Hospital at 1 site in China.
Trial summary
This study is to evaluate the effect of anal dilation in infants and children with constipation. Read more about this study
- Who is it for?
- Ages 1 month to 14 years
- Conditions the study is for
- Constipation
- What is being tested?
- Lactulose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Sep 2014to Oct 2016
- 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 1 month to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants and Children With Constipation
- Postoperative infants and children with Hirschsprung's disease
- Good compliance
Who cannot join
- Infants and Children With Constipation
- Poor compliance
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital
Wuhan, Hubei, 430030
Zhi Li, MD PhD, +8613387664883, lizhimdphd@163.com
About this study
This study is to evaluate the effect of anal dilation in infants and children with constipation.
- Conditions
- Constipation
- Being tested
- Lactulose
- Keywords
- infants and children with constipation
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LactuloseDrug
| Study group | Role | What they receive |
|---|---|---|
| anal dilatation | Active comparator | Not described Receives: Drug: Lactulose |
| Oral Lactulose | Active comparator | Not described Receives: Drug: Lactulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily stool times
Measured: two years
Secondary outcomes (2)
The frequency of intestinal peristalsis waves
Measured: two years
The amplitude of intestinal peristalsis waves
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 posted3 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionAug 2016 (estimated)
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiexiong Feng, Tongji Hospital
- Investigators
- Jiexiong, Feng, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02255747
- Sponsor's protocol ID
- Anal Dilatation
- Status last verified
- Sep 2014
- First submitted
- 28 Sep 2014
- Last updated
- 3 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anal Dilatation for Infants and Children With Constipation
- ClinicalTrials.gov ID
- NCT02255747
- Acronym / sponsor ID
- Anal Dilatation
- Conditions
- Constipation
- Keywords
- infants and children with constipation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 3 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.
This study is to evaluate the effect of anal dilation in infants and children with constipation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| anal dilatation | Active comparator | Drug: Lactulose |
| Oral Lactulose | Active comparator | Drug: Lactulose |
Who may qualify
- Ages
- 1 month to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Infants and Children With Constipation
- Postoperative infants and children with Hirschsprung's disease
- Good compliance
Key exclusion criteria (2 listed)
- Infants and Children With Constipation
- Poor compliance
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 |
|---|---|---|
| Lactulose | Drug | Oral Lactulose, anal dilatation |
Primary outcome
Daily stool times
Time frame: two years
2 secondary outcomes
The frequency of intestinal peristalsis waves
Time frame: two years
The amplitude of intestinal peristalsis waves
Time frame: two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2014.
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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.
Jiexiong, Feng principal investigator
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactulose in people with Constipation, run by Tongji 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 3 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 3 Oct 2014. 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.
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 Zhi Li, MD PhD (+8613387664883, lizhimdphd@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily stool times (time frame: two years). 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 3 Oct 2014.