ConstipationNCT00467350
Comparison Trial of Enema vs. PEG 3350 for Constipation
A study testing PEG 3350 and milk and molasses enema in people with Constipation, run by Children's Mercy Hospital Kansas City at 1 site in United States.
Trial summary
The purpose of this study is to determine if milk and molasses enema or PEG 3350 works better for treatment of fecal impaction in children who are constipated. Read more about this study
- Who is it for?
- Ages 1 year to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Constipation
- What is being tested?
- PEG 3350 and milk and molasses enema
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to May 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 year to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Constipated children who have one of the following three conditions:
- Fecal impaction (lower quadrant mass or dilated rectum with hard stool),
- Functional fecal retention (large diameter stools as determined by caregiver <twice/week and retentive behaviors, or
- Excessive stool in colon on abdominal radiograph as determined by attending radiologist or treating physician
Who cannot join
- Ill appearing patients (signs of acute surgical abdomen, abnormal vital signs, or overall ill appearing as determined by treating physician)
- Patients whose evaluation in the ED includes more than plain radiographs or urinalysis
- Patients who receive analgesia for the abdominal pain in the ED (except acetaminophen or ibuprofen)
- Non-English speaking patients and families
- Patients with milk allergy
- Patients with molasses allergy
Show all 9Show fewer
- Patients who are pregnant
- Patients with a chronic medical conditions which may be associated with constipation (including patients with cystic fibrosis, cerebral palsy, hypothyroidism, spinal anomalies, and known gastrointestinal anatomic abnormalities) or a history of prior abdominal or rectal surgery
- Patients who are admitted to an in-patient unit
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Mercy Hospital
Kansas City, Missouri, 64108
About this study
Official title: Randomized Clinical Trial of Milk and Molasses Enema vs. PEG 3350 for Fecal Impaction in Childhood Constipation
The purpose of this study is to determine if milk and molasses enema or PEG 3350 works better for treatment of fecal impaction in children who are constipated.
Read the detailed description
Constipation is a common condition in childhood and occurs without evidence of a pathological condition in most children. Symptoms range from decreased appetite to abdominal pain and constipation is frequently diagnosed in children evaluated in emergency departments. A general guideline for constipation treatment is fecal impaction removal before initiation of maintenance therapy. Disimpaction may be achieved using various oral therapies (e.g. including Polyethylene Glycol 3350 or PEG); however, rectal therapies, most commonly enemas, are frequently used, especially in the emergency/urgent care setting. The optimal treatment has not been established. There are no published randomized studies that compare effectiveness of oral versus rectal treatments.
Comparison: One milk and molasses enema given to the patient in the emergency department compared to three oral doses of PEG 3350 for relief of symptoms due to fecal impaction and constipation.
- Conditions
- Constipation
- Being tested
- PEG 3350, milk and molasses enema
- Keywords
- constipation, treatment, fecal impaction, pediatric
- Medical subject headings
- Constipation, Fecal Impaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG 3350Drug
Also called Miralax
PEG 3350 1.5 gram/kg for disimpaction then 0.8 gram/kg for maintenance
milk and molasses enemaDrug
Also called enema
enema 10 cc/kg per rectum (max 500 cc)then PEG 3350 0.8 gram/kg for maintenance
| Study group | Role | What they receive |
|---|---|---|
| enema | Active comparator | Rectal enema containing mixture of milk and molasses Receives: Drug: milk and molasses enema |
| PEG 3350 | Active comparator | Medication to be taken orally once each day for three consecutive days Receives: Drug: PEG 3350 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Participants With Main Symptom Improvement
On day 5, the number of participants who respond "improved" to the question "Has your child's main symptom improved, stayed the same or gotten worse?"
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2007 (estimated)
- Study startDec 2006
- Primary completionMay 2009
- Study completionMay 2009
Why it stopped: concern patients in oral cleaout arm had worse outcome
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melissa Miller, Children's Mercy Hospital Kansas City
- Investigators
- Melissa K Miller, MD, Principal investigator, Children's Mercy Hospital Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00467350
- Sponsor's protocol ID
- 06-07-117
- Status last verified
- Oct 2020
- First submitted
- 26 Apr 2007
- Last updated
- 2 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of Milk and Molasses Enema vs. PEG 3350 for Fecal Impaction in Childhood Constipation
- ClinicalTrials.gov ID
- NCT00467350
- Acronym / sponsor ID
- 06-07-117
- Conditions
- Constipation
- Keywords
- constipation, treatment, fecal impaction, pediatric
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: concern patients in oral cleaout arm had worse outcome
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 30 Apr 2007 (estimated)
- Results
- Posted 2 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if milk and molasses enema or PEG 3350 works better for treatment of fecal impaction in children who are constipated.
Detailed description
Constipation is a common condition in childhood and occurs without evidence of a pathological condition in most children. Symptoms range from decreased appetite to abdominal pain and constipation is frequently diagnosed in children evaluated in emergency departments. A general guideline for constipation treatment is fecal impaction removal before initiation of maintenance therapy. Disimpaction may be achieved using various oral therapies (e.g. including Polyethylene Glycol 3350 or PEG); however, rectal therapies, most commonly enemas, are frequently used, especially in the emergency/urgent care setting. The optimal treatment has not been established. There are no published randomized studies that compare effectiveness of oral versus rectal treatments.
Comparison: One milk and molasses enema given to the patient in the emergency department compared to three oral doses of PEG 3350 for relief of symptoms due to fecal impaction and constipation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| enema | Active comparator | Drug: milk and molasses enemaRectal enema containing mixture of milk and molasses |
| PEG 3350 | Active comparator | Drug: PEG 3350Medication to be taken orally once each day for three consecutive days |
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Constipated children who have one of the following three conditions:
Key exclusion criteria (9 listed)
- Ill appearing patients (signs of acute surgical abdomen, abnormal vital signs, or overall ill appearing as determined by treating physician)
- Patients whose evaluation in the ED includes more than plain radiographs or urinalysis
- Patients who receive analgesia for the abdominal pain in the ED (except acetaminophen or ibuprofen)
- Non-English speaking patients and families
- Patients with milk allergy
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 |
|---|---|---|
| PEG 3350Also: MiralaxPEG 3350 1.5 gram/kg for disimpaction then 0.8 gram/kg for maintenance | Drug | PEG 3350 |
| milk and molasses enemaAlso: enemaenema 10 cc/kg per rectum (max 500 cc)then PEG 3350 0.8 gram/kg for maintenance | Drug | enema |
Primary outcome
The Number of Participants With Main Symptom Improvement
Time frame: 5 days
On day 5, the number of participants who respond "improved" to the question "Has your child's main symptom improved, stayed the same or gotten worse?"
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
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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.
Melissa K Miller, MD principal investigator
Children's Mercy Hospital Kansas City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEG 3350 and milk and molasses enema in people with Constipation, run by Children's Mercy Hospital Kansas City at 1 site in United States.
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 4 inclusion and 9 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: stopped early, as of the sponsor's last update on 2 Nov 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 United States. 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?
Yes. Results are posted in the registry (first posted 2 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Number of Participants With Main Symptom Improvement (time frame: 5 days). 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 2 Nov 2020.