ConstipationPhase 4NCT05821309
Evaluation of Fecal Microbiome Changes After Antegrade Continence Enema Placement and Initiation of Bowel Flush Regimen
A Phase 4 study testing PEG 3350, PEG-3350 with electrolytes and Glycerin in people with Constipation, run by Indiana University at 2 sites in United States.
Trial summary
This study will evaluate changes in the fecal microbiome in constipated pediatric patients before and after antegrade continence enema placement and initiation of antegrade enema flushes. Subjects will have their microbiome sequenced prior to placement by obtaining a fecal sample. Read more about this study
- Who is it for?
- Ages 2 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Constipation
- What is being tested?
- PEG 3350, PEG-3350 with electrolytes and Glycerin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Jun 2023to Jul 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 2 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Recalcitrant chronic functional constipation necessitating a MACE appendicostomy or cecostomy for treatment at Riley Hospital for Children
- Intact colonic motility as evidenced by CMS studies
Who cannot join
- Underlying anatomic or pathologic etiology for constipation
- History of prior gastrointestinal surgery (excluding placement of G or GJ tubes)
- Underlying severe GI disease unrelated to the patient's chronic constipation
- Use within the past month of consent of probiotic supplements, prebiotic supplements or antibiotics
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
IU North Hospital
Carmel, Indiana, 46032
Erik Andrewski, MD, 317-944-3774, edandrew@iu.edu
Ann Klipsch, RN, 317-944-3774, aeye@iu.edu
- Recruiting
Riley Hospital for Children
Indianapolis, Indiana, 46224
Erik Andrewski, MD, 317-944-3774, edandrew@iupui.edu
Ann Klipsch, RN, 317-944-3774, aeye@iu.edu
About this study
This study will evaluate changes in the fecal microbiome in constipated pediatric patients before and after antegrade continence enema placement and initiation of antegrade enema flushes. Subjects will have their microbiome sequenced prior to placement by obtaining a fecal sample. Pre-antegrade continence enema placement results will be compared to fecal samples obtained at 0, 4, 8 months after placement of the antegrade continence enema and initiation of miralax or golytely flushes to look for changes in bacterial diversity.
Read the detailed description
This is a prospective, longitudinal study of children 2 -18 years of age who undergo a clinical Malone Antegrade Continence Enema (MACE) appendicostomy or cecostomy for treatment of chronic functional constipation as defined by the Rome IV criteria. Only patients with intact motility on colonic manometry (CMS) will be included. The antegrade enema flush medication regimen will be randomized in 1:1 ratio of PEG 3350 and PEG3350 with electrolytes. The study statistician will create a blocked randomization schedule which will be uploaded into REDCap. Glycerin and stimulant laxatives will be titrated as needed by a pediatric gastroenterologist in conjunction with the pediatric general surgery team. Neither patient nor providers will be blinded to laxative randomization as objective data in the form of microbiome composition is being evaluated.
Patients will have a pre-MACE placement stool sample obtained at time of colonic motility studies and repeat stool samples collected at 1 month, 4 months and 8 months post-MACE placement and initiation of antegrade enemas. Post-MACE samples will be submitted at standard follow-up appointments. All stool samples will be self-collected by patients. Samples will be collected with the OMNIgene GUT kit which provides stabilization of DNA at room temperature for up to 60 days. Once the sample is collected by the research team, sample tubes will be stored at -80 Celsius until all samples are collected and sent for sequencing. Pre-MACE stool samples will be collected while abstaining from osmotic laxative therapy for one week. If patients do not spontaneously pass stool during the week of osmotic laxative abstention, stool will be collected from the first bowel movement after pre-CMS bowel flush with PEG 3350 with or without electrolytes has been initiated. Data regarding if stool collection occurred before or after receiving PEG 3350 with or without electrolytes for CMS bowel flush will be recorded. Patients will perform daily flushes after MACE placement and post-MACE stool samples will be collected within the first 10 minutes of flush initiation.
- Conditions
- Constipation
- Being tested
- PEG 3350, PEG-3350 with electrolytes, Glycerin
- Keywords
- Fecal microbiome, Malone Antegrade Continence Enema (MACE), Miralax, PEG 3350, Antegrade Continence Enema, Chronic Constipation
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG 3350Drug
Also called MiraLAX or generic equivalent
The purpose of this study is to determine if a sustained change in the fecal microbiome occurs after prolonged use of an antegrade continence enema bowel flush regimen. Patients' microbiomes will be evaluated via 16s rRNA sequencing. PEG 3350 will be compared to PEG 3350 with electrolytes
PEG-3350 with electrolytesDrug
Also called GoLytely or generic equivalent
The purpose of this study is to determine if a sustained change in the fecal microbiome occurs after prolonged use of an antegrade continence enema bowel flush regimen. Patients' microbiomes will be evaluated via 16s rRNA sequencing. PEG 3350 will be compared to PEG 3350 with electrolytes
GlycerinDrug
Glycerin will be given to patients based on standard of care, at the discretion of the pediatric gastroenterology and pediatric surgery teams. Glycerin administration will not be randomized. For secondary analysis, the microbiomes of those who have and have not received glycerin will be compared.
| Study group | Role | What they receive |
|---|---|---|
| PEG 3350 | Experimental | Patients will receive PEG 3350 (miralax or generic equivalent) for their MACE flushes. Receives: Drug: PEG 3350; Drug: Glycerin |
| PEG 3350 with electrolytes | Experimental | Patients will receive PEG 3350 with electrolytes (Go-Lytely or generic equivalent) for their MACE flushes. Receives: Drug: PEG-3350 with electrolytes; Drug: Glycerin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fecal Microbiome at 1 month
The purpose of this study is to determine if a sustained change in the fecal microbiome occurs after prolonged use of an antegrade continence enema bowel flush regimen. Patients' microbiomes will be evaluated via 16s rRNA sequencing
Measured: At baseline and 1 month post-MACE
Change in Fecal Microbiome at 4 months
The purpose of this study is to determine if a sustained change in the fecal microbiome occurs after prolonged use of an antegrade continence enema bowel flush regimen. Patients' microbiomes will be evaluated via 16s rRNA sequencing
Measured: At baseline and 4 months post-MACE
Change in Fecal Microbiome at 8 months
The purpose of this study is to determine if a sustained change in the fecal microbiome occurs after prolonged use of an antegrade continence enema bowel flush regimen. Patients' microbiomes will be evaluated via 16s rRNA sequencing
Measured: At baseline and 8 months post-MACE
Secondary outcomes (3)
Effect of Bowel Regimen Solution on Fecal Bacterial Diversity
Determine whether a difference in fecal bacterial diversity determined by 16s rRNA sequencing exists between differing MACE bowel regimens of 1. Bisacodyl and PEG 3350 in electrolyte solution (GoLytely) or 2. Bisacodyl and PEG 3350 without electrolytes (Miralax).
Measured: Through study completion, approximately 8 months
Effect of Glycerin on Fecal Microbiome Diversity
Determine whether patients receiving glycerin in addition to PEG 3350 with or without electrolytes display differences in their fecal microbiota as measured by 16s rRNA sequencing.
Measured: Through study completion, approximately 8 months
Effect of Redundant Sigmoid Colon on Microbiome Diversity
Evaluate for differences in the fecal microbiome determined by 16s rRNA sequencing between those patients who have a redundant sigmoid colon based on barium enema results and those who do not
Measured: Through study completion, approximately 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start8 Jun 2023
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (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 Indiana UniversityThe 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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kathryn Hawa, DO, Indiana University
- Investigators
- Kate Hawa, DO, Principal investigator, Riley Hospital for Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05821309
- Sponsor's protocol ID
- 17083
- Status last verified
- Aug 2026
- First submitted
- 7 Apr 2023
- Last updated
- 18 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Fecal Microbiome Changes After Antegrade Continence Enema Placement and Initiation of Bowel Flush Regimen
- ClinicalTrials.gov ID
- NCT05821309
- Acronym / sponsor ID
- 17083
- Conditions
- Constipation
- Keywords
- Fecal microbiome, Malone Antegrade Continence Enema (MACE), Miralax, PEG 3350, Antegrade Continence Enema, Chronic Constipation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 8 Jun 2023 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 20 Apr 2023 (actual)
- 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 will evaluate changes in the fecal microbiome in constipated pediatric patients before and after antegrade continence enema placement and initiation of antegrade enema flushes. Subjects will have their microbiome sequenced prior to placement by obtaining a fecal sample. Pre-antegrade continence enema placement results will be compared to fecal samples obtained at 0, 4, 8 months after placement of the antegrade continence enema and initiation of miralax or golytely flushes to look for changes in bacterial diversity.
Detailed description
This is a prospective, longitudinal study of children 2 -18 years of age who undergo a clinical Malone Antegrade Continence Enema (MACE) appendicostomy or cecostomy for treatment of chronic functional constipation as defined by the Rome IV criteria. Only patients with intact motility on colonic manometry (CMS) will be included. The antegrade enema flush medication regimen will be randomized in 1:1 ratio of PEG 3350 and PEG3350 with electrolytes. The study statistician will create a blocked randomization schedule which will be uploaded into REDCap. Glycerin and stimulant laxatives will be titrated as needed by a pediatric gastroenterologist in conjunction with the pediatric general surgery team. Neither patient nor providers will be blinded to laxative randomization as objective data in the form of microbiome composition is being evaluated.
Patients will have a pre-MACE placement stool sample obtained at time of colonic motility studies and repeat stool samples collected at 1 month, 4 months and 8 months post-MACE placement and initiation of antegrade enemas. Post-MACE samples will be submitted at standard follow-up appointments. All stool samples will be self-collected by patients. Samples will be collected with the OMNIgene GUT kit which provides stabilization of DNA at room temperature for up to 60 days. Once the sample is collected by the research team, sample tubes will be stored at -80 Celsius until all samples are collected and sent for sequencing. Pre-MACE stool samples will be collected while abstaining from osmotic laxative therapy for one week. If patients do not spontaneously pass stool during the week of osmotic laxative abstention, stool will be collected from the first bowel movement after pre-CMS bowel flush with PEG 3350 with or without electrolytes has been initiated. Data regarding if stool collection occurred before or after receiving PEG 3350 with or without electrolytes for CMS bowel flush will be recorded. Patients will perform daily flushes after MACE placement and post-MACE stool samples will be collected within the first 10 minutes of flush initiation.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEG 3350 | Experimental | Drug: PEG 3350, Drug: GlycerinPatients will receive PEG 3350 (miralax or generic equivalent) for their MACE flushes. |
| PEG 3350 with electrolytes | Experimental | Drug: PEG-3350 with electrolytes, Drug: GlycerinPatients will receive PEG 3350 with electrolytes (Go-Lytely or generic equivalent) for their MACE flushes. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Recalcitrant chronic functional constipation necessitating a MACE appendicostomy or cecostomy for treatment at Riley Hospital for Children
- Intact colonic motility as evidenced by CMS studies
Key exclusion criteria (4 listed)
- Underlying anatomic or pathologic etiology for constipation
- History of prior gastrointestinal surgery (excluding placement of G or GJ tubes)
- Underlying severe GI disease unrelated to the patient's chronic constipation
- Use within the past month of consent of probiotic supplements, prebiotic supplements or antibiotics
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: MiraLAX or generic equivalentThe purpose of this study is to determine if a sustained change in the fecal microbiome occurs after prolonged use of an antegrade continence enema bowel flush regimen. Patients' microbiomes will be evaluated via 16s rRNA sequencing. PEG 3350 will be compared to PEG 3350 with electrolytes | Drug | PEG 3350 |
| PEG-3350 with electrolytesAlso: GoLytely or generic equivalentThe purpose of this study is to determine if a sustained change in the fecal microbiome occurs after prolonged use of an antegrade continence enema bowel flush regimen. Patients' microbiomes will be evaluated via 16s rRNA sequencing. PEG 3350 will be compared to PEG 3350 with electrolytes | Drug | PEG 3350 with electrolytes |
| GlycerinGlycerin will be given to patients based on standard of care, at the discretion of the pediatric gastroenterology and pediatric surgery teams. Glycerin administration will not be randomized. For secondary analysis, the microbiomes of those who have and have not received glycerin will be compared. | Drug | PEG 3350, PEG 3350 with electrolytes |
Primary outcome
Change in Fecal Microbiome at 1 month
Time frame: At baseline and 1 month post-MACE
The purpose of this study is to determine if a sustained change in the fecal microbiome occurs after prolonged use of an antegrade continence enema bowel flush regimen. Patients' microbiomes will be evaluated via 16s rRNA sequencing
Change in Fecal Microbiome at 4 months
Time frame: At baseline and 4 months post-MACE
The purpose of this study is to determine if a sustained change in the fecal microbiome occurs after prolonged use of an antegrade continence enema bowel flush regimen. Patients' microbiomes will be evaluated via 16s rRNA sequencing
Change in Fecal Microbiome at 8 months
Time frame: At baseline and 8 months post-MACE
The purpose of this study is to determine if a sustained change in the fecal microbiome occurs after prolonged use of an antegrade continence enema bowel flush regimen. Patients' microbiomes will be evaluated via 16s rRNA sequencing
3 secondary outcomes
Effect of Bowel Regimen Solution on Fecal Bacterial Diversity
Time frame: Through study completion, approximately 8 months
Effect of Glycerin on Fecal Microbiome Diversity
Time frame: Through study completion, approximately 8 months
Effect of Redundant Sigmoid Colon on Microbiome Diversity
Time frame: Through study completion, approximately 8 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Kate Hawa, DO principal investigator
Riley Hospital for Children
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PEG 3350, PEG-3350 with electrolytes and Glycerin in people with Constipation, run by Indiana University at 2 sites 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 2 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erik Andrewski, MD (317-944-3774, edandrew@iupui.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fecal Microbiome at 1 month (time frame: At baseline and 1 month post-MACE). The study lists 3 primary outcomes in all. 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 18 Aug 2026.