Encopresis With Constipation and Overflow IncontinenceEarly Phase 1NCT07604025
Senna vs. Polyethylene Glycol 3350 for the Treatment of Retentive Encopresis in Children
A Early Phase 1 study testing PEG 3350 and Senna in people with Encopresis With Constipation and Overflow Incontinence, run by Shaare Zedek Medical Center at 2 sites in Israel.
Trial summary
The goal of this clinical trial is to learn which treatment is more effective for children with functional constipation (FC) and fecal incontinence (FI), also called retentive encopresis. Functional constipation is common in children and can cause pain, embarrassment, social stress, and repeated medical visits. Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Encopresis With Constipation and Overflow Incontinence
- What is being tested?
- PEG 3350 and Senna
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesIsrael
- Study dates
- 1 Jul 2026to 1 Jan 2028
- Phase
- Early Phase 1
- 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 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 4 to 18 years.
- Diagnosis of functional constipation according to Rome IV criteria.
- Fecal incontinence occurring ≥4 times per week.
- Treatment-naïve or treatment-experienced (i.e., any of the following treatments in the past: PEG, senna, bisacodyl and rectal disimpaction) patients.
Who cannot join
- Presence of organic disease that causes or contributes to fecal incontinence (e.g., Hirschsprung disease, spinal cord anomalies, anorectal malformations).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Israel2 sites
Shamir Medical Center
Be’er Ya‘aqov
Adi Ein Dor
Shaare Zedek Medical Center
Jerusalem, 91031
Zivia Shavit, Msc, +972-54-2520204, zivias@szmc.org.il
Dotan Yogev, MD
About this study
Official title: Senna vs. Polyethylene Glycol 3350 for the Treatment of Retentive Encopresis in Children: a Randomized, Double-blinded, Study
The goal of this clinical trial is to learn which treatment is more effective for children with functional constipation (FC) and fecal incontinence (FI), also called retentive encopresis.
Functional constipation is common in children and can cause pain, embarrassment, social stress, and repeated medical visits. One of the hardest symptoms to treat is fecal incontinence. Two common treatments are polyethylene glycol 3350 (PEG), an osmotic laxative, and Senna, a plant-based stimulant laxative. PEG is often used as standard maintenance therapy, while Senna is increasingly used, especially in children with difficult or refractory constipation. However, there is not enough high-quality evidence comparing these two treatments directly in children with fecal incontinence.
Read more
The main question this study aims to answer is:
Does Senna reduce the number of fecal incontinence episodes more than PEG after 3 months of treatment? The study will also assess safety, tolerability, abdominal pain or cramping, use of rescue enemas, treatment satisfaction, and treatment compliance.
This is a prospective, randomized, double-blinded clinical trial. Children will be randomly assigned to receive either daily Senna or daily PEG for 3 months. Neither the families nor the treating medical team will know which treatment the child is receiving. Both medications will be prepared as identical-looking white powder in identical packages.
Participants will be children aged 4 to 18 years who have functional constipation according to Rome IV criteria and have fecal incontinence at least 4 times per week. Children with an organic disease that may cause fecal incontinence, such as Hirschsprung disease, spinal cord abnormalities, or anorectal malformations, will not be included.
Before starting the study medication, all participants will complete a 3-day bowel clean-out using high-dose PEG, with Pico-Salax added on the third day. After this clean-out, children will start their assigned daily treatment, either Senna or PEG. The dose will be based on age and may be adjusted by the physician according to stool consistency, stool frequency, cramping, and the child's clinical response. All families will also receive behavioral advice, including regular toilet sitting twice daily, correct toilet position using a footstool, and going to the toilet when the child feels the need.
Participants will:
- Take daily Senna or daily PEG for 3 months
- Visit the clinic at baseline, 1 month, 2 months, and 3 months
- Complete a 7-day stool and fecal incontinence diary before each visit
- Report abdominal pain, cramping, diarrhea, perianal irritation, or any other adverse events
- Return medication containers so compliance can be checked by weighing the remaining medication
- Complete satisfaction and improvement questionnaires at the 3-month visit
Outcome Measurements:
The primary outcome is the mean number of fecal incontinence episodes per week after 3 months of treatment. This will be measured using a prospective 7-day diary completed by the family before the 3-month clinic visit.
The secondary outcomes, assessed at 3 months, include:
- Change in patient-initiated toilet sitting, meaning times when the child independently says they need to defecate
- The proportion of children who reach 0-1 fecal incontinence episodes per week
- The proportion of children with any improvement, defined as at least 1 fewer fecal incontinence episode per week
- Number of rescue enemas used during the 3-month study period
- Frequency and severity of abdominal pain or cramping
- Parent-reported satisfaction with treatment using a 5-point Likert scale
- Family impression of overall improvement using a 5-point Likert scale
- The proportion of children still meeting Rome IV criteria for functional constipation
- Treatment compliance, defined as good compliance if more than 80% of doses were taken
The study plans to enroll 80 children total, with 40 children in the Senna group and 40 children in the PEG group.
- Being tested
- PEG 3350, Senna
- Keywords
- Functional constipation, Retentive encoperesis, Encoperesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG 3350Drug
Patients assigned to the PEG group will receive age-based dosing according to standard clinical guidelines, with flexibility for dosing adjustments. Each container will contain an identical white powder and a measuring spoon. One measuring spoon will contain 17g of PEG. Initial dosing will be according to age groups as follows:
- 4-7 years: ½ spoon, once daily
- 8-18 years: 1 spoon, once daily
SennaDietary supplement
Patients assigned to the Senna group will receive age-based dosing, in line with standard clinical guidelines and clinical practice. Dosing adjustments will be permitted and encouraged throughout the trial based on physician judgment at clinical visits or family-initiated requests. Each container will contain an identical white powder and a measuring spoon. One measuring spoon will contain 20mg of Senna. Initial dosing will be according to age groups as follows:
- 4-7 years: ½ spoon, once daily
- 8-18 years: 1 spoon, once daily
| Study group | Role | What they receive |
|---|---|---|
| PEG 3350 | Active comparator | Not described Receives: Drug: PEG 3350 |
| Senna | Active comparator | Not described Receives: Dietary Supplement: Senna |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of fecal incontinence incidents per week at 3 months
Mean number of fecal incontinence episodes per week at 3 months of treatment. A prospective 7-day diary will be completed by the family, at enrollment and before each monthly visit. The 3-month clinic meeting diary will be used to measure this outcome.
Measured: At 3 months
Secondary outcomes (9)
Change in patient-initiated toilet-sitting
Improvement in patient-initiated toilet-sitting: To understand changes in bowel habits, the study will distinguish between parent-initiated toilet sitting ("it's time to go to the bathroom/I think you need to poop") and patient-initiated toilet sitting ("I need to go!"). Changes in the number of patient-initiated sittings/week throughout the study will be compared between both treatments.
Measured: At 3 months
Proportion of patients achieving 0-1 fecal incontinence episodes per week.
Measured: At 3 months
Proportion of patients achieving any improvement (≥1 episode/week reduction)
Measured: At 3 months
Number of enemas used during the 3-month period
Measured: From enrollment till 3 months
Proportion of patients experiencing mild versus moderate-to-severe abdominal pain or cramping (classified by physician and family report).
Measured: From enrollment till 3 months
Parent-reported satisfaction with treatment
Parent-reported satisfaction with treatment will be measured on a 5-point Likert scale from "Very Satisfied" to "Very Dissatisfied".
Measured: At 3 months
Family impression of overall improvement
Family impression of overall improvement will be measured on a 5-point Likert scale from "Very Satisfied" to "Very Dissatisfied".
Measured: At 3 months
Proportion of patients still meeting Rome IV criteria for functional constipation
Measured: At 3 months
Compliance Assessment: Compliance with assigned treatment will be assessed based weighing the medication containers: Classification as "good compliance" (>80% doses taken) versus "poor compliance" (<80%)
Measured: From enrollment till 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Encopresis With Constipation and Overflow IncontinenceStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Assaf-Harofeh Medical Center
- Responsible party
- Principal investigator, Yogev Dotan, Shaare Zedek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07604025
- Sponsor's protocol ID
- Senna vs PEG
- Status last verified
- Jun 2026
- First submitted
- 17 May 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Senna vs. Polyethylene Glycol 3350 for the Treatment of Retentive Encopresis in Children: a Randomized, Double-blinded, Study
- ClinicalTrials.gov ID
- NCT07604025
- Acronym / sponsor ID
- Senna vs PEG
- Keywords
- Functional constipation, Retentive encoperesis, Encoperesis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Collaborators
- Assaf-Harofeh Medical Center
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 22 May 2026 (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.
The goal of this clinical trial is to learn which treatment is more effective for children with functional constipation (FC) and fecal incontinence (FI), also called retentive encopresis.
Functional constipation is common in children and can cause pain, embarrassment, social stress, and repeated medical visits. One of the hardest symptoms to treat is fecal incontinence. Two common treatments are polyethylene glycol 3350 (PEG), an osmotic laxative, and Senna, a plant-based stimulant laxative. PEG is often used as standard maintenance therapy, while Senna is increasingly used, especially in children with difficult or refractory constipation. However, there is not enough high-quality evidence comparing these two treatments directly in children with fecal incontinence.
The main question this study aims to answer is:
Does Senna reduce the number of fecal incontinence episodes more than PEG after 3 months of treatment? The study will also assess safety, tolerability, abdominal pain or cramping, use of rescue enemas, treatment satisfaction, and treatment compliance.
This is a prospective, randomized, double-blinded clinical trial. Children will be randomly assigned to receive either daily Senna or daily PEG for 3 months. Neither the families nor the treating medical team will know which treatment the child is receiving. Both medications will be prepared as identical-looking white powder in identical packages.
Participants will be children aged 4 to 18 years who have functional constipation according to Rome IV criteria and have fecal incontinence at least 4 times per week. Children with an organic disease that may cause fecal incontinence, such as Hirschsprung disease, spinal cord abnormalities, or anorectal malformations, will not be included.
Before starting the study medication, all participants will complete a 3-day bowel clean-out using high-dose PEG, with Pico-Salax added on the third day. After this clean-out, children will start their assigned daily treatment, either Senna or PEG. The dose will be based on age and may be adjusted by the physician according to stool consistency, stool frequency, cramping, and the child's clinical response. All families will also receive behavioral advice, including regular toilet sitting twice daily, correct toilet position using a footstool, and going to the toilet when the child feels the need.
Participants will:
- Take daily Senna or daily PEG for 3 months
- Visit the clinic at baseline, 1 month, 2 months, and 3 months
- Complete a 7-day stool and fecal incontinence diary before each visit
- Report abdominal pain, cramping, diarrhea, perianal irritation, or any other adverse events
- Return medication containers so compliance can be checked by weighing the remaining medication
- Complete satisfaction and improvement questionnaires at the 3-month visit
Outcome Measurements:
The primary outcome is the mean number of fecal incontinence episodes per week after 3 months of treatment. This will be measured using a prospective 7-day diary completed by the family before the 3-month clinic visit.
The secondary outcomes, assessed at 3 months, include:
- Change in patient-initiated toilet sitting, meaning times when the child independently says they need to defecate
- The proportion of children who reach 0-1 fecal incontinence episodes per week
- The proportion of children with any improvement, defined as at least 1 fewer fecal incontinence episode per week
- Number of rescue enemas used during the 3-month study period
- Frequency and severity of abdominal pain or cramping
- Parent-reported satisfaction with treatment using a 5-point Likert scale
- Family impression of overall improvement using a 5-point Likert scale
- The proportion of children still meeting Rome IV criteria for functional constipation
- Treatment compliance, defined as good compliance if more than 80% of doses were taken
The study plans to enroll 80 children total, with 40 children in the Senna group and 40 children in the PEG group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEG 3350 | Active comparator | Drug: PEG 3350 |
| Senna | Active comparator | Dietary Supplement: Senna |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged 4 to 18 years.
- Diagnosis of functional constipation according to Rome IV criteria.
- Fecal incontinence occurring ≥4 times per week.
- Treatment-naïve or treatment-experienced (i.e., any of the following treatments in the past: PEG, senna, bisacodyl and rectal disimpaction) patients.
Key exclusion criteria (1 listed)
- Presence of organic disease that causes or contributes to fecal incontinence (e.g., Hirschsprung disease, spinal cord anomalies, anorectal malformations).
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 3350Patients assigned to the PEG group will receive age-based dosing according to standard clinical guidelines, with flexibility for dosing adjustments. Each container will contain an identical white powder and a measuring spoon. One measuring spoon will contain 17g of PEG. Initial dosing will be according to age groups as follows: * 4-7 years: ½ spoon, once daily * 8-18 years: 1 spoon, once daily | Drug | PEG 3350 |
| SennaPatients assigned to the Senna group will receive age-based dosing, in line with standard clinical guidelines and clinical practice. Dosing adjustments will be permitted and encouraged throughout the trial based on physician judgment at clinical visits or family-initiated requests. Each container will contain an identical white powder and a measuring spoon. One measuring spoon will contain 20mg of Senna. Initial dosing will be according to age groups as follows: * 4-7 years: ½ spoon, once daily * 8-18 years: 1 spoon, once daily | Dietary supplement | Senna |
Primary outcome
Number of fecal incontinence incidents per week at 3 months
Time frame: At 3 months
Mean number of fecal incontinence episodes per week at 3 months of treatment. A prospective 7-day diary will be completed by the family, at enrollment and before each monthly visit. The 3-month clinic meeting diary will be used to measure this outcome.
9 secondary outcomes
Change in patient-initiated toilet-sitting
Time frame: At 3 months
Proportion of patients achieving 0-1 fecal incontinence episodes per week.
Time frame: At 3 months
Proportion of patients achieving any improvement (≥1 episode/week reduction)
Time frame: At 3 months
Number of enemas used during the 3-month period
Time frame: From enrollment till 3 months
Proportion of patients experiencing mild versus moderate-to-severe abdominal pain or cramping (classified by physician and family report).
Time frame: From enrollment till 3 months
Parent-reported satisfaction with treatment
Time frame: At 3 months
Family impression of overall improvement
Time frame: At 3 months
Proportion of patients still meeting Rome IV criteria for functional constipation
Time frame: At 3 months
Compliance Assessment: Compliance with assigned treatment will be assessed based weighing the medication containers: Classification as "good compliance" (>80% doses taken) versus "poor compliance" (<80%)
Time frame: From enrollment till 3 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 Jun 2026.
- Individual participant dataSharing planned: Undecided
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing PEG 3350 and Senna in people with Encopresis With Constipation and Overflow Incontinence, run by Shaare Zedek Medical Center at 2 sites in Israel.
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 1 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: opening soon, as of the sponsor's last update on 18 Jun 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 Israel. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Dotan Yogev, MD (+972-50-8668221, dotany@szmc.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of fecal incontinence incidents per week at 3 months (time frame: At 3 months). 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 Jun 2026.