Chronic ConstipationPhase 1/2NCT06543979
Anorectal Manometery in Pediatric Chronic Refractory Constipation
A Phase 1/2 study testing lubiprostone , single arm, biofeed back sessions and botox injection in people with Chronic Constipation, run by Ain Shams University at 1 site in Egypt.
Trial summary
Anorectal manometry and high-resolution anorectal manometry (HRAM) are becoming the investigation of choice for understanding the pathophysiology of chronic constipation with or without fecal incontenance in children in many institutions. Read more about this study
- Who is it for?
- Ages 4 to 16 years
- Conditions the study is for
- Chronic Constipation
- What is being tested?
- lubiprostone , single arm, biofeed back sessions and botox injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Sep 2024to 1 Oct 2025
- Phase
- Phase 1/2
- 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 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children and adolescents aged from 4 to 16 years.
- Participants fulfilling Rome IV criteria for the diagnosis of functional constipation.
- At least 2 of the following present at least once per week for at least 1 month:
- 2 or fewer defecations in the toilet per week
- At least 1 episode of fecal incontinence per week
- History of retentive posturing or excessive volitional stool retention
Show all 11Show fewer
- History of painful or hard bowel movements
- Presence of a large fecal mass in the rectum
- History of large-diameter stools that may obstruct the toilet The symptoms cannot be fully explained by another medical condition (Hyams et al., 2016).
- Participants who have chronic refractory constipation. Chronic refractory constipation (CRC) is defined as children who are unable to pass stools in spite of being on maximum laxative therapy and require daily rectal stimulation in the form of enemas or suppositories to pass stools 4-Is willing and able to keep a diary on his/her own and willing and able to complete a questionnaire.
- 5-The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
Who cannot join
- participants who have anorectal malformation
- participants who have neurological disease affecting lower limbs
- Has a history of hypersensitivity or allergies to lubiprostone
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
yosra mohamed mohsen awad, MD contact
Egypt1 site, 1 recruiting
- Recruiting
Ain shams university
Cairo
Asmaa Abdelnaby, Master, 01070689789, Samka2015.abdelnaby@gmail.com
About this study
Official title: The Diagnostic Value of Anorectal Manometry in Pediatric Chronic Refractory Constipation With or Without Fecal Incontinence
Anorectal manometry and high-resolution anorectal manometry (HRAM) are becoming the investigation of choice for understanding the pathophysiology of chronic constipation with or without fecal incontenance in children in many institutions. In high resolution anorectal manometery we are able to gain information whether the symptoms are related to sphincter dysfunction, impaired sensation, or pelvic floor dyssynergia
Read the detailed description
Primary objective: To assess different patterns of anorectal manometry in children with chronic refractory constipation with or without fecal incontinence.
Secondary objective: To determine the effectiveness of different modalities of treatment of chronic refractory constipation based on the anorectal findings. To assess the safety ,tolerability and effectiveness of lubiprostone in pediatric age group with chronic refractory constipation. To assess the effect of elimination of cow milk products in patient with chronic refractory constipation.
- Conditions
- Chronic Constipation
- Being tested
- lubiprostone , single arm, biofeed back sessions, botox injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lubiprostone , single armDrug
Also called lubicont
laxative
biofeed back sessionsProcedure or surgery
Biofeedback for participants with dyssynergic defecation and participants with reduced rectal sensations
botox injectionProcedure or surgery
Botulinum toxin injection for participants suffering from elevated anal canal pressure
| Study group | Role | What they receive |
|---|---|---|
| single arm as all participant will receive the treatment | Other | all participant will receive lubiprostone Receives: Drug: lubiprostone , single arm; Procedure: biofeed back sessions; Procedure: botox injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the manometric parameters in children with chronic refractory constipation
To measure the percent of the most common manometric parameters in children with chronic refractory constipation e.g dyssengeric defecation and reduced rectal sensetivity and anal sphincter dysfunction.
Measured: 1 year
evaluate the efficacy of oral administration of lubiprostone 8 and 24 μg once daily for 4 weeks in participants with chronic refractory constipation
Spontaneous Bowel Movement (SBM) Frequency at Week 1,2,3 and 4 A SBM was defined as any bowel movement (BM) that does not occur within 24 hours after rescue medication use (laxative, suppository, or enema). Participants will be given a diary to complete at home where they will record all details of each SBM including the consistency of the stool and the difficulty they have in passing it.
Measured: 1 month
Secondary outcomes (3)
To determine the effect of biofeed back sessions in children with dyssengeric defecation and in children with rectal hyposensetivity
Participants with chronic refractory constipation and manometry parameters showed dyssengeric defecation or hyposensitivity will receive biofeedback sessions and the investigators measure the difference in bowel management scoring tool before and after the biofeedback sessions the higher the score the worest the condition
Measured: 3 months
To determine the effect of cow milk protein free diet on chronic refractory constipation in children
Participants will receive cow milk free diet for 4 weeks and investigators measure the difference in bowel management scoring tool before and after cow milk free diet the higher the score the worest the condition
Measured: 1 month
To determine the effect of botulinum toxin injection in children with elevated anal canal resting pressure
Participants with chronic refractory and manometric parameters showed high anal canal resting pressure will have botulinum toxin injection and investigators measure the difference in bowel management scoring tool before and after the injection the higher the score the worest the condition
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start7 Sep 2024
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, asmaa abdelnaby, Ain Shams University
- Investigators
- asmaa abdelnaby mohamed soliman, master, Principal investigator, assistant lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06543979
- Sponsor's protocol ID
- manometery in constipation
- Status last verified
- Oct 2024
- First submitted
- 9 May 2024
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Diagnostic Value of Anorectal Manometry in Pediatric Chronic Refractory Constipation With or Without Fecal Incontinence
- ClinicalTrials.gov ID
- NCT06543979
- Acronym / sponsor ID
- manometery in constipation
- Conditions
- Chronic Constipation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 7 Sep 2024 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 9 Aug 2024 (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.
Anorectal manometry and high-resolution anorectal manometry (HRAM) are becoming the investigation of choice for understanding the pathophysiology of chronic constipation with or without fecal incontenance in children in many institutions. In high resolution anorectal manometery we are able to gain information whether the symptoms are related to sphincter dysfunction, impaired sensation, or pelvic floor dyssynergia
Detailed description
Primary objective: To assess different patterns of anorectal manometry in children with chronic refractory constipation with or without fecal incontinence.
Secondary objective: To determine the effectiveness of different modalities of treatment of chronic refractory constipation based on the anorectal findings. To assess the safety ,tolerability and effectiveness of lubiprostone in pediatric age group with chronic refractory constipation. To assess the effect of elimination of cow milk products in patient with chronic refractory constipation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm as all participant will receive the treatment | Other | Drug: lubiprostone , single arm, Procedure: biofeed back sessions, Procedure: botox injectionall participant will receive lubiprostone |
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- Children and adolescents aged from 4 to 16 years.
- Participants fulfilling Rome IV criteria for the diagnosis of functional constipation.
- Participants who have chronic refractory constipation. Chronic refractory constipation (CRC) is defined as children who are unable to pass stools in spite of being on maximum laxative therapy and require daily rectal stimulation in the form of enemas or suppositories to pass stools 4-Is willing and able to keep a diary on his/her own and willing and able to complete a questionnaire.
- 5-The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
Key exclusion criteria (3 listed)
- participants who have anorectal malformation
- participants who have neurological disease affecting lower limbs
- Has a history of hypersensitivity or allergies to lubiprostone
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 |
|---|---|---|
| lubiprostone , single armAlso: lubicontlaxative | Drug | single arm as all participant will receive the treatment |
| biofeed back sessionsBiofeedback for participants with dyssynergic defecation and participants with reduced rectal sensations | Procedure or surgery | single arm as all participant will receive the treatment |
| botox injectionBotulinum toxin injection for participants suffering from elevated anal canal pressure | Procedure or surgery | single arm as all participant will receive the treatment |
Primary outcome
To evaluate the manometric parameters in children with chronic refractory constipation
Time frame: 1 year
To measure the percent of the most common manometric parameters in children with chronic refractory constipation e.g dyssengeric defecation and reduced rectal sensetivity and anal sphincter dysfunction.
evaluate the efficacy of oral administration of lubiprostone 8 and 24 μg once daily for 4 weeks in participants with chronic refractory constipation
Time frame: 1 month
Spontaneous Bowel Movement (SBM) Frequency at Week 1,2,3 and 4 A SBM was defined as any bowel movement (BM) that does not occur within 24 hours after rescue medication use (laxative, suppository, or enema). Participants will be given a diary to complete at home where they will record all details of each SBM including the consistency of the stool and the difficulty they have in passing it.
3 secondary outcomes
To determine the effect of biofeed back sessions in children with dyssengeric defecation and in children with rectal hyposensetivity
Time frame: 3 months
To determine the effect of cow milk protein free diet on chronic refractory constipation in children
Time frame: 1 month
To determine the effect of botulinum toxin injection in children with elevated anal canal resting pressure
Time frame: 3 month
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 9 Oct 2024.
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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.
yosra mohamed mohsen awad, MD contact
asmaa abdelnaby mohamed soliman, master principal investigator
assistant lecturer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing lubiprostone , single arm, biofeed back sessions and botox injection in people with Chronic Constipation, run by Ain Shams University at 1 site in Egypt.
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 11 inclusion and 3 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 9 Oct 2024. 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 Egypt. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 asmaa abdelnaby mohamed soliman, master (+2001070689789, samka2015.abdelnaby@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the manometric parameters in children with chronic refractory constipation (time frame: 1 year). The study lists 2 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 9 Oct 2024.