NCT00467350

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 30, 2007

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
11.5 years until next milestone

Results Posted

Study results publicly available

November 2, 2020

Completed
Last Updated

November 2, 2020

Status Verified

October 1, 2020

Enrollment Period

2.4 years

First QC Date

April 26, 2007

Results QC Date

August 19, 2020

Last Update Submit

October 9, 2020

Conditions

Constipation

Keywords

constipationtreatmentfecal impactionpediatric

Outcome Measures

Primary Outcomes (1)

  • 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?"

    5 days

Study Arms (2)

enema

ACTIVE COMPARATOR

Rectal enema containing mixture of milk and molasses

Drug: milk and molasses enema

PEG 3350

ACTIVE COMPARATOR

Medication to be taken orally once each day for three consecutive days

Drug: PEG 3350

Interventions

PEG 3350DRUG

PEG 3350 1.5 gram/kg for disimpaction then 0.8 gram/kg for maintenance

Also known as: Miralax
PEG 3350
milk and molasses enemaDRUG

enema 10 cc/kg per rectum (max 500 cc)then PEG 3350 0.8 gram/kg for maintenance

Also known as: enema
enema

Eligibility Criteria

Age1 Year - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

MeSH Terms

Conditions

ConstipationFecal Impaction

Interventions

polyethylene glycol 3350MilkEnema

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsIntestinal ObstructionIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

BeveragesDiet, Food, and NutritionPhysiological PhenomenaDairy ProductsFoodFood and BeveragesDrug TherapyTherapeutics

Limitations and Caveats

More than half of patients who were approached declined participation. A moderate number of patients (29%) were lost to follow-up.

Results Point of Contact

Title
Melissa Miller MD
Organization
Children's Mercy Hospitals and Clinics
mmiller@cmh.edu
8162343000

Study Officials

  • Melissa K Miller, MD

    Children's Mercy Hospital Kansas City

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 26, 2007

First Posted

April 30, 2007

Study Start

December 1, 2006

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

November 2, 2020

Results First Posted

November 2, 2020

Record last verified: 2020-10

Locations

US(1)