A Phase 4 interventional study of Dose Response - NS and USP Glycerin - First Intervention and Effectiveness - NS and USP Glycerin - Second Intervention in Fecal Incontinence and Neurogenic Bowel, sponsored by Nemours Children's Clinic. Completed at 1 site in United States. Open to participants aged 3 Years to 12 Years. Per ClinicalTrials.gov, last updated 2019-08-28.
Sponsored by Nemours Children's Clinic · Phase 4, Interventional, and Supportive care
Among 101 studies in Fecal Incontinence with a site in United States — 14 open to participants now, 19 under way, 2 of them phase 3. Fecal Incontinence · United States.
Among the 101 studies in Fecal Incontinence with a site in United States, this one is the 71st largest by enrollment of the 79 interventional ones that give a count, is one of 4 that started in 2016, is one of 5 in phase 4, and was the 42nd registered.
283 studies on the registry are indexed under Fecal Incontinence; 52 are open to participants now.
Browse Fecal Incontinence studies →14 of the 101 studies in Fecal Incontinence with a site in United States are open now. Recruiting first, the newest first:
University of Colorado, Denver · Sites in United States
Cedars-Sinai Medical Center · Sites in United States
Axonics, Inc. · Sites in United States, United Kingdom
Axonics, Inc. · Sites in United States, Australia
David Chu · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 38 Fecal Incontinence studies recruiting now, 25 (66%) set no upper age limit and 9 (24%) stop at 75 or younger; 6 take children under 18; 3 take healthy volunteers.
This study: 3 Years to 12 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
101 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 7 · Phase 2 7 · Phase 3 5 · Phase 4 5
First in 1998; this study’s year is marked. 4 started in 2016.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 5 is below the median of 50 across 203 interventional studies indexed under Fecal Incontinence.
Median enrollment 44 across the 79 interventional studies, 80 across the 21 observational. Of the 70 that completed or were terminated, 35 (50%) have results posted.
This tab as a report to print or save as PDF → With an account.
27 of 101 have an industry lead sponsor. The 10 most frequent:
Nemours Children's Clinic is the lead sponsor of 130 studies on the registry; 26 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Nemours Children's Clinic has 1 study filed under Fecal Incontinence — fewer than ten, so there is no comparison to draw.
11 of the studies in Fecal Incontinence with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05776277Phase 3Cook MyoSiteIltamiocel Compared to Placebo for Chronic Fecal Incontinence in Females With Obstetric Injury | 2026-12 |
| NCT07335484Axonics, Inc.Aquarius Pilot Study to Evaluate the New Axonics Trial System | 2026-11 |
| NCT04506593Indiana UniversityIndiana University Gastrointestinal Motility Diagnosis Registry | 2026-11 |
| NCT06186765Axonics, Inc.F15 Recharge Free Axonics SNM System Clinical Study | 2026-12 |
| NCT05200923MedtronicNeuroPelvic Health Electrically Evoked Recording (PEER) 2 Study | 2026-12-18 |
Among the 101 studies in Fecal Incontinence with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
There is a surgical procedure to help children with intractable fecal incontinence gain continence for stool through construction of a tube that connects the abdominal wall to the colon near or through the appendix. This tube allows easy administration of enema solution into the first part of the colon. Putting enema solution through that tube into the colon is called an antegrade continence enema (ACE) and has been shown to work well in helping some but not all children prevent stool accidents. The purpose of this study is to compare a large volume ACE flush using a salt water solution called normal saline with a small volume ACE flush using liquid glycerin. The aims of this study are to: 1) find the most effective dose and flush frequency of each solution needed to prevent stool accidents; 2) compare which solution given at the best dose has the least side effects and 3) to determine if administration of either of the ACE flushing solutions causes electrolyte abnormalities or affects colon health.
Fecal incontinence past the time of toilet training is devastating to affected children. Antegrade continence enema (ACE) therapy administered through a catheterizable stoma surgically placed in the cecum has helped children with intractable fecal incontinence attain continence for stool. There are a number of retrospective studies demonstrating the variable effectiveness rates of ACE therapy. This variability may be due to what is used to flush. There are no prospective trials evaluating the effectiveness of different flushing regimens. The catheterizable stoma used for the antegrade administration of enema solution is frequently made by bringing the appendix out through the abdominal wall or by placing a skin-level device (button) in to the cecum. ACE therapy administration through the appendix or into the cecum has the potential to cause colonic dysfunction. The effects of ACE administration on colonic mucosal health has not been investigated. This pilot study will compare a high volume normal saline (NS) flush and a low volume United States Pharmacopeia (USP) glycerin flush. The primary aims of the study are to compare which solution, given at an optimal dose and frequency, is associated with fewer side effects, while promoting the higher degree of fecal continence, and to determine if antegrade enema solution administration through an appendicostomy/cecostomy causes electrolyte abnormalities or affects gut health.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Baseline data including frequency and severity of fecal soiling and frequency and severity of abdominal pain were collected for a minimum of 2 weeks prior to surgical construction of the ACE stoma. Baseline stool calprotectin and serum electrolytes were collected in the baseline phase prior to initiation of the preoperative bowel prep. Pre-operative data served as the control.
Initial flush used NS or USP Glycerin randomized to treatment sequence. The starting volume and administration frequency for NS was 10mL/kg and glycerin 20 mL administered every other day. The NS dose was titrated in 10 mL increments to achieve continence so as not to exceed 500 mL daily for a child under five years of age and 1000 mL daily for a child over 5 years of age. USP Glycerin was titrated in 5 mL increments so as not to exceed 50 mL daily. For side effects greater than Wong Bailey Faces Pain Rating Scale (WBFPRS) level 4, NS was decreased by 2.5 mL/kg to the lowest dose of 5 mL/kg daily. USP Glycerin was decreased in 5 mL increments to the lowest dose of 5 mL daily. If the maximum dose did not result in continence, if the dose necessary to minimize side effects resulted in fecal soiling, or if there were side effects greater than WBFPRS level 4 at the lowest dose of administration, the child was be trialed on the alternate therapy and then dropped from the study.
Drug: Dose Response - NS and USP Glycerin - First Intervention
To prevent statistical bias from subject loss due to treatment failure, each child was randomized to a second treatment sequence once they achieved continence on optimal dosing with minimal side effects.This arm evaluated the long term effectiveness of NS and glycerin at optimal dose and administration frequency for 4 weeks and served as comparison between flush solutions. The study concluded with the child being placed back on 2 weeks of the initial flush in the randomized sequence.
Drug: Effectiveness - NS and USP Glycerin - Second Intervention
This trial used a repeated measures, single subjects alternating treatments A-B-C-B'-C'-B1' withdrawal design in which all subjects were tested under all conditions and each subject acted as his or her own control. The subjects were randomly assigned to either normal saline or USP glycerin to control for order effects. Baseline data A served as the control and was obtained pre-operatively. The B-C arm evaluated dose-response relationship and was used to identify the minimum dosing volume and frequency of ACE administration of NS and USP Glycerin necessary to promote fecal continence. When the optimal dose as identified, the child continued on that dose for 2 weeks to insure treatment stability and effectiveness.
Also known as: 0.9% sodium chloride solution, Glycerol, Glycerin
To prevent statistical bias from subject loss due to treatment failure, each child was randomized to a second treatment sequence once they have achieved continence with minimal side effects on optimal dosing The second phase B'-C'-B1' of the study compared the two regimens at optimal dose and administration frequency. This phase was used to confirm the effectiveness of NS and USP Glycerin at optimal dosing on continence and assess side effects.
Also known as: 0.9% sodium chloride solution, Glycerol, Glycerin
Fecal Soiling - Number of Participants That Gained and Maintained Continence on Each Flushing Regimen
Fecal soiling was defined as non-toilet elimination, which was tracked and documented by the parent/child as direct event recording and tallied as the number of pairs of underwear/protective undergarments soiled with stool per day. The purpose of this outcome measure was to document the number of individuals who gained continence on NS and USP glycerin. Descriptive statistics was limited to percentage of total participants who achieved continence on each flushing regimen. Data was calculated on the last data point in the final phase for both the NS and USP glycerin flush.
Time frame: Data collection started following consent and procedural training and was collected daily from day 1 for the duration of the study, an average of 135 days.
Fecal Soiling - Quantitative Count Detailing the Number of Episodes of Fecal Incontinence Per Day on NS and USP Glycerin
Fecal soiling was defined as non-toilet elimination, which was tracked and documented by the parent/child as direct event recording and tallied as the number of pairs of underwear/protective undergarments soiled with stool per day. Descriptive statistics included mean and standard deviation. Inferential statistical analysis was accomplished using a two-tailed, two-sample pooled variance t test with a significance level set at 0.05, calculated on the data from the last day of the completed NS and USP Glycerin phases of the study. Power analysis conducted using data from this study with α = 0.5, power of .80, correlation between two means of .598, and effect size of 1.554 estimated a sample size of 11 would be needed to minimize the risk of a Type II error to (20%).
Time frame: Data collection began following consent and procedural training and was collected daily from day 1 for the duration of the study, an average of 135 days.
NS and USP Glycerin Flush Solution Dosing Frequency Necessary to Achieve Continence
Flush administration frequency necessary to achieve continence was recorded as a single measure per subject per flush solution obtained as the number of flushes in the last three days of each dosing phase and recorded as either daily (1), every other day (2), or every third day (3). The larger the value, the less frequent the flush, the better the clinical outcome. Dosing frequency was measured using direct observational recording completed by the parent or child. Descriptive analysis included mean, and standard deviation. Inferential statistical analysis was accomplished using a two-tailed, two-sample pooled variance t test with a significance level set at 0.05. Descriptive and inferential statistics were calculated on the data from the last day of the completed NS and USP Glycerin phases of the study.
Time frame: Frequency of administration data was collected as the total number of flushes recieved over the last three days of each dosing phase for both NS and USP Glycerin and recorded as either daily (1), every other day (2), or every third day
Flush Volume
Flush volume was measured in mL/flush using a graduated cylinder and recorded by the parent or child with each flush and later calculated in mL/kg. Data derived from the last flush of the completed dosing phase of both NS and USP Glycerin were used to calculate flush volume. Descriptive analysis included mean, median, range, and standard deviation. Reported data excludes subjects who failed to gain and maintain continence on either flushing regimen.
Time frame: Data for analysis was collected from the last flush of the NS and USP Glycerin dosing phase of the study
Number of Participants With Any Electrolyte Abnormality
Evaluated impact of NS and USP Glycerin antegrade flush on serum electrolytes using a blood test called a Basic Metabolic Panel. Data analysis limited to percentage of subjects demonstrating any electrolyte abnormality on NS or USP glycerin.
Time frame: Collection dates included a baseline sample (week 1) and at the completion of the dosing trail for both NS and USP glycerin for a total of 3 samples
Change in Stool Calprotectin Levels Assessed Through Comparing Levels Obtained Following Completion of NS and USP Glycerin Dosing Phases With the Baseline Value For Each Subject
Stool calprotectin was used to evaluate the impact of NS and USP Glycerin antegrade flush on colonic health. Calprotectin levels were obtained at baseline and following completion of the NS and USP Glycerin dosing phase of the study. Descriptive data analysis included mean and standard deviation for each flush regimen. Inferential statistical analysis was accomplished using a two-tailed, two-sample pooled variance t test with a significance level set at 0.05. Both descriptive and inferential data analysis was calculated on the difference in calprotectin levels between samples obtained at baseline and samples obtained following the completion of the NS and USP Glycerin flush (value at completion of dosing phase - baseline value). The assumption was the length of each dosing phase was sufficient to achieve a credible active washout period and therefore levels obtained at the end of a phase reflected flushing regimen effects colonic health regardless of flush order.
Time frame: Collection dates included a baseline sample (week 1) and at the completion of the dosing trail for both NS and USP glycerin for a total of 3 samples
Cramping With Flush
Cramping with flush was measured using the Wong Baker Faces Pain Rating Scale (WBFPRS). The WBFPRS has undergone extensive testing and has well established psychometrics in the pediatric population. The scale ranges from 0 (very happy without pain) to 10 (the worse pain imaginable). Each pain level is associated with a facial expression. The child is asked to choose the face that best describes his/her level of discomfort (ordinal data). The parent was instructed to call if the child had flushing regimen-associated discomfort greater than a 4 on the WBFPRS. Documentation of pain severity was completed by the parent and child on a data-collection form at the time of occurrence. Descriptive statistics including mean and standard deviation. Inferential statistical analysis was accomplished using a two-tailed, two-sample pooled variance t test with a significance level set at 0.05. Descriptive and inferential statistics were calculated on the last data point in the dosing phase.
Time frame: Data analysis was completed on data obtained during the last flush in both the NS and USP Glycerin dosing phase
Number of Participants Experiencing Vagal Symptoms With Flush
Vagal symptoms including nausea, vomiting, sweating, dizziness, and pallor were noted by the parent. The parent was instructed to call if the child had any vagal symptoms. Documentation of any vagal symptoms was completed by the parent and child on a data-collection form at the time of occurrence. Data was analyzed as a percentage of subjects experiencing vagal symptoms during flush with NS and USP glycerin.
Time frame: Data collection started with the first flush administered following discharge from the hospital and was collected with every subsequent flush through completion of the study, an average of 115 days.
Participants recruited from subspecialty clinics at Nemours Children's Clinic in Jacksonville, Florida between February 2016 and January of 2017
| Milestone | No Intervention: Pre-operative Baseline Phase | Post-Operative Dose Response: NS Then USP Glycerin | Post-Operative Dose Response: USP Glycerin Then NS | Effectiveness Phase: NS Then USP Glycerin | Effectiveness Phase: USP Glycerin Then NS |
|---|---|---|---|---|---|
| Started | 5 | 0 | 0 | 0 | 0 |
| Completed | 5 | 0 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 |
| Milestone | No Intervention: Pre-operative Baseline Phase | Post-Operative Dose Response: NS Then USP Glycerin | Post-Operative Dose Response: USP Glycerin Then NS | Effectiveness Phase: NS Then USP Glycerin | Effectiveness Phase: USP Glycerin Then NS |
|---|---|---|---|---|---|
| Started | 0 | 3 | 2 | 0 | 0 |
| Completed | 0 | 2 | 1 | 0 | 0 |
| Not completed | 0 | 1 | 1 | 0 | 0 |
| Withdrew: Adverse event | 0 | 1 | 1 | 0 | 0 |
| Milestone | No Intervention: Pre-operative Baseline Phase | Post-Operative Dose Response: NS Then USP Glycerin | Post-Operative Dose Response: USP Glycerin Then NS | Effectiveness Phase: NS Then USP Glycerin | Effectiveness Phase: USP Glycerin Then NS |
|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 1 | 1 |
| Completed | 0 | 0 | 0 | 1 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 1 |
| Withdrew: Lack of efficacy | 0 | 0 | 0 | 0 | 1 |
Fecal soiling was defined as non-toilet elimination, which was tracked and documented by the parent/child as direct event recording and tallied as the number of pairs of underwear/protective undergarments soiled with stool per day. The purpose of this outcome measure was to document the number of individuals who gained continence on NS and USP glycerin. Descriptive statistics was limited to percentage of total participants who achieved continence on each flushing regimen. Data was calculated on the last data point in the final phase for both the NS and USP glycerin flush.
| Participants | Subjects Continent on NS Antegrade Flush | Subjects Continent on USP Glycerin |
|---|---|---|
| Fecal Soiling - Number of Participants That Gained and Maintained Continence on Each Flushing Regimen | 1 | 4 |
Fecal soiling was defined as non-toilet elimination, which was tracked and documented by the parent/child as direct event recording and tallied as the number of pairs of underwear/protective undergarments soiled with stool per day. Descriptive statistics included mean and standard deviation. Inferential statistical analysis was accomplished using a two-tailed, two-sample pooled variance t test with a significance level set at 0.05, calculated on the data from the last day of the completed NS and USP Glycerin phases of the study. Power analysis conducted using data from this study with α = 0.5, power of .80, correlation between two means of .598, and effect size of 1.554 estimated a sample size of 11 would be needed to minimize the risk of a Type II error to (20%).
| underwear soiled/day | Episodes of Fecal Incontinence on NS Antegrade Flush | Episodes of Fecal Incontinence on USP Glycerin Antegrade Flush |
|---|---|---|
| Fecal Soiling - Quantitative Count Detailing the Number of Episodes of Fecal Incontinence Per Day on NS and USP Glycerin | 2 ± 1.87 | 0.2 ± 0.45 |
Flush administration frequency necessary to achieve continence was recorded as a single measure per subject per flush solution obtained as the number of flushes in the last three days of each dosing phase and recorded as either daily (1), every other day (2), or every third day (3). The larger the value, the less frequent the flush, the better the clinical outcome. Dosing frequency was measured using direct observational recording completed by the parent or child. Descriptive analysis included mean, and standard deviation. Inferential statistical analysis was accomplished using a two-tailed, two-sample pooled variance t test with a significance level set at 0.05. Descriptive and inferential statistics were calculated on the data from the last day of the completed NS and USP Glycerin phases of the study.
| Flush administration/day | Dosing Frequency on NS | Dosing Frequency on USP Glycerin |
|---|---|---|
| NS and USP Glycerin Flush Solution Dosing Frequency Necessary to Achieve Continence | 1 ± 0 | 1.6 ± 0.894 |
Flush volume was measured in mL/flush using a graduated cylinder and recorded by the parent or child with each flush and later calculated in mL/kg. Data derived from the last flush of the completed dosing phase of both NS and USP Glycerin were used to calculate flush volume. Descriptive analysis included mean, median, range, and standard deviation. Reported data excludes subjects who failed to gain and maintain continence on either flushing regimen.
| mL/flush | Flush Volume of NS | Flush Volume of USP Glycerin |
|---|---|---|
| Flush Volume | 39.215 ± 12.424 | 1.475 ± 0.457 |
Evaluated impact of NS and USP Glycerin antegrade flush on serum electrolytes using a blood test called a Basic Metabolic Panel. Data analysis limited to percentage of subjects demonstrating any electrolyte abnormality on NS or USP glycerin.
| Participants | Elelctrolye Abnormalities on NS FLush | Elelctrolye Abnormalities on USP Glycerin FLush |
|---|---|---|
| Number of Participants With Any Electrolyte Abnormality | 0 | 0 |
Stool calprotectin was used to evaluate the impact of NS and USP Glycerin antegrade flush on colonic health. Calprotectin levels were obtained at baseline and following completion of the NS and USP Glycerin dosing phase of the study. Descriptive data analysis included mean and standard deviation for each flush regimen. Inferential statistical analysis was accomplished using a two-tailed, two-sample pooled variance t test with a significance level set at 0.05. Both descriptive and inferential data analysis was calculated on the difference in calprotectin levels between samples obtained at baseline and samples obtained following the completion of the NS and USP Glycerin flush (value at completion of dosing phase - baseline value). The assumption was the length of each dosing phase was sufficient to achieve a credible active washout period and therefore levels obtained at the end of a phase reflected flushing regimen effects colonic health regardless of flush order.
| μg/g | Calprotectin Levels Following NS FLush | Calprotectin Levels Following USP Glycerin FLush |
|---|---|---|
| Change in Stool Calprotectin Levels Assessed Through Comparing Levels Obtained Following Completion of NS and USP Glycerin Dosing Phases With the Baseline Value For Each Subject | 133.7 ± 183.359 | 108 ± 113.874 |
Cramping with flush was measured using the Wong Baker Faces Pain Rating Scale (WBFPRS). The WBFPRS has undergone extensive testing and has well established psychometrics in the pediatric population. The scale ranges from 0 (very happy without pain) to 10 (the worse pain imaginable). Each pain level is associated with a facial expression. The child is asked to choose the face that best describes his/her level of discomfort (ordinal data). The parent was instructed to call if the child had flushing regimen-associated discomfort greater than a 4 on the WBFPRS. Documentation of pain severity was completed by the parent and child on a data-collection form at the time of occurrence. Descriptive statistics including mean and standard deviation. Inferential statistical analysis was accomplished using a two-tailed, two-sample pooled variance t test with a significance level set at 0.05. Descriptive and inferential statistics were calculated on the last data point in the dosing phase.
| units on a scale | Pain With NS Antegrade Flush Administration | Pain With USP Glycerin Antegrade Flush Administration |
|---|---|---|
| Cramping With Flush | 0 ± 0 | 0.4 ± 0.89 |
Vagal symptoms including nausea, vomiting, sweating, dizziness, and pallor were noted by the parent. The parent was instructed to call if the child had any vagal symptoms. Documentation of any vagal symptoms was completed by the parent and child on a data-collection form at the time of occurrence. Data was analyzed as a percentage of subjects experiencing vagal symptoms during flush with NS and USP glycerin.
| Participants | Vagal Symptoms With NS FLush | Vagal Symptoms With USP Glycerin Flush |
|---|---|---|
| Number of Participants Experiencing Vagal Symptoms With Flush | 0 | 1 |
Collected over 1 year 1 month. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Vagal Symptoms With NS Flush | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Vagal Symptoms With USP Glycerin Flush | 0/5 (0%) | 0/5 (0%) | 1/5 (20%) |
| Event | Vagal Symptoms With NS Flush | Vagal Symptoms With USP Glycerin Flush |
|---|---|---|
| Vasovagal ResponseVascular disorders | 0/5 | 1/5 |
| Age, Categorical(Participants) | No Intervention: Pre-operative Baseline Phase |
|---|---|
| <=18 years | 5 |
| Between 18 and 65 years | 0 |
| >=65 years | 0 |
| Age, Continuous(months) | No Intervention: Pre-operative Baseline Phase |
|---|---|
| Mean | 66.6 ± 29.3309 |
| Sex: Female, Male(Participants) | No Intervention: Pre-operative Baseline Phase |
|---|---|
| Female | 0 |
| Male | 5 |
| Race/Ethnicity, Customized(participants) | No Intervention: Pre-operative Baseline Phase |
|---|---|
| Caucasian | 2 |
| Asian | 1 |
| Hispanic | 1 |
| African-American | 1 |
| Region of Enrollment(participants) | No Intervention: Pre-operative Baseline Phase |
|---|---|
| United States | 5 |
| Cause of Neurogenic bowel(participants) | No Intervention: Pre-operative Baseline Phase |
|---|---|
| myelomeningocele | 4 |
| Spinal Cord Trauma - MVA | 1 |
| Patulent anus(participants) | No Intervention: Pre-operative Baseline Phase |
|---|---|
| Number | 5 |
| Ambulatory(participants) | No Intervention: Pre-operative Baseline Phase |
|---|---|
| Ambulatory | 4 |
| Wheel Chair User | 1 |
1 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Feb 2016 to primary completion in Mar 2017, 13 months.
Results were first posted in Aug 2019, 2 years 4 months after primary completion.
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